1. Intrathecal Infusion Patient Selection
Pre-Pump-Implant Trials
Surgical Implantation Techniques
Intraoperative Complications
Post-Operative Complications
Outcome Studies
Algosresearch
Algosresearch.org

2. SLIDE INDEX
Contributions by J Patrick Couch, Elliott Krames, K Follett, J Ordia
 Physician Qualifications/Clinics- Slide 4
 Patient Selection- Slide 7
 Neuraxial Screening Trials- Slide 34
 Surgical Techniques- Slide 87
 Intraoperative Complications- Slide 148
 Early Postoperative Complications-Slide 161
 Late Postoperative Complications-Slide 189
 Medication Effects-Slide 226
 Selected Outcome Studies- Slide 252

3. WE EACH HAVE OUR OWN TALENTS
Not everyone should be implanting pumps

4. Physician Qualifications/Training
 Because pain medicine has no residency
program, no defined scope of practice, or no
defined standards for intrathecal pump
implantation, the qualifications are nebulous
 From a practical standpoint, only full time pain
physicians or those with full time pain coverage
by other physicians qualified to implant pumps
should be implanting these devices
 Surgical skills are very useful and may help
avoid or reduce complications
 Some pain physicians will perform only the trial
then perform the refills for an implanting
neurosurgeon.

5. Clinic Setup
 An intrathecal pump service is far more complex
than a simple block or RF service
 Requirements include: FDA tracking, medication
log, access to medical records 24 hours a day in
case the patient is admitted to another institution,
nurse in charge of tracking/refills/medication
orders, 24 hour a day availability by a physician
qualified to implant pumps and manage
complications, quality assurance in intrathecal
medication sterility and expiration times, pump
refill kits, screening psych tools pre-implantation,
billing is understood, contacting patients re: refills

6. Pre-Implantation:
 Conservative Measures Exhausted
 High Dose Oral or Transdermal Opiates Have
Been Tried with Intractable Side Effects
 Psych Screen OK
 Extended Informed Consent
 Insurance approval or criteria met
 Appropriate venue: Medicare cannot be
implanted in an ASC
 Functional Intrathecal Trial
 Systems are in place for office refills, pump
tracking, physician backup for vacations
 Malpractice Insurance

7. Intrathecal Infusion
Therapy:
Patient Selection

8. Many Choices in Pain
Management

9. Patient Selection:
The Good, The Bad,
and the Ugly

10. Classic Patient Selection Criteria
 Seven patient selection criteria for intrathecal
pump implantation, Elliot Krames, M.D. J Pain
& Symptom Mgt., 1996:
 More conservative therapies have failed
 An observable pathology exists that is concordant
with the pain complaint
 Further surgical intervention is not indicated
 No serious untreated drug habituation exists
 Psychological evaluation and clearance for
implantation has been obtained
 No contraindications to implantation exist
 A Screening Test has been successful

11. Considerations for Implantation
Whitworth, 2003
 Medically necessary
 Failure of conservative therapy
 Psychologically stable
 Financially feasible
 Refill considerations (timing, cost)
 Adequate trial
 No anticipated definitive surgery
 Risk/benefit ratio acceptable
 Technical pump implant considerations

12. Common Indications for
Intrathecal Therapy
 Chronic non-malignant pain treatment
 Cancer pain treatment
 Spasticity treatment
 Chemotherapy administration

13. Medical Conditions That May
Respond to Intrathecal
Therapy
 CRPS with spasticity or more than 1
extremity involvement
 Peridural fibrosis
 Neuropathic pain (less responsive)
 Spasticity (s/p CVA, MS, dystonias, CP)
 CNS spinal cord tumors
 Central pain (poor response)
 FMS (variable response-need good trial)

14. Medical Necessity Means:
 Other more conservative therapies have
been tried (often for more than 2-3 mos)
 Opiate/local/alpha2 responsive pain or
baclofen responsiveness of spasticity
 There are no definitive surgical treatments
available
 The therapy is a standard accepted and
indicated therapy for the particular
condition

15. Conservative Therapy Failure
 Oral or transdermal medications (several
types) produce significant side effects of
mentation changes, hypersedation, or
inadequate pain relief. Constipation,
pruritis, urinary retention are common
features of intrathecal therapy therefore
the presence of these side effects during
oral or transdermal opiate therapy is not a
definitive indication for intrathecal therapy.
Nausea and vomiting may be improved
with IT therapy.

16. Other Failure Indicators in
Conservative Therapy
 Failure to significantly affect pain when
targeted
 Failure to significantly improve
functionality
 Significant side effects are occurring with
conservative therapy which are intolerable
in spite of adjunctive measures

17. Some Contraindications Based
on Conservative Therapy
Observations
 Patient passivity
 Unwilling to participate in functional
restoration programs, injection
therapies, or psychological treatment
 Excessive optimism regarding post
implant pain relief
 You have become the messiah

18. Other Contraindications
 Pre-existing pedal edema: edema can
become severe in 30% with intrathecal MS
infusions (Eur J Pain. 2000;4(4):361-5.
Leg edema from intrathecal opiate
infusions. Aldrete JA)
 Significant systemic side effects of
transdermal, oral, or parenteral drugs of
the same type to be infused
 Any underlying infection at the time of
surgery

19. Psych
Eval

20. Psychological Considerations
 Psychological assessment: (1) exposes
psychological factors that should be
addressed in treatment; (2) suggests
specific treatments that may help resolve
psychological risk factors; (3) facilitates
patient selection for specific pain
therapies; and (4) provides clues to
evaluate the patient's response to a
screening test or treatment.

21. Important Psych Contraindications
 Untreated moderate to severe depression
 Severe personality disorders
 Suicidal
 Homicidal
 Severe obsessive-compulsive
 Somatization
 Substance abuse
 Unable to tolerate implantation of subcutaneous
pump due to self image problems or underlying
psych problems
 Manipulative or chronically dissatisfied

22. Psychomimetric Instruments
 MMPI
 BHI
 P90
 P3
 Face to face evaluation with psychologist
(most important of all)

23. Substance Abuse Issues
 Cannot be defined
without a narcotic
agreement which
spells out clinic
rules for
prescribing and
violations of these
rules.
 Patient induced overdose,
script alteration, threats of
legal action unless narcotics
are prescribed, and diversion
of meds are absolute issues.
 Lost or stolen drugs,
positive UDS for illegal
drugs, negative UDS for
prescribed drugs, repeated
calls afterhours for drugs,
failure to keep scheduled
appts, etc. all warrant
extreme caution.

24. By implanting
an intrathecal
pump, you are
married to the
patient

25. Marriage and IT Pumps
 Dance a little before you decide to get
married
 Don’t marry anyone you don’t like (divorce
of a patient with a pump is messy)
 Don’t implant a pump to silence a patient
from complaining about pain: it will not.
Patients will still complain just as much
after implantation.

26. Financial Considerations
 Acquisition cost to
hospitals/ASC for
pump plus catheter
ranges from $5,500 to
10,500.
 Implant costs plus
trial plus acquisition
costs may exceed
$20,000
 Break even point
usually does not occur
until 9-15 months
after implantation
(money savings on
oral meds)
 Medicaid does not
cover pumps.
 Because of the costs,
the deductable alone
can thwart
implantation

27. Do Not Implant Programmable
Pumps In Patients Who:
 May not have insurance in the future
 Who are anticipated to have Medicaid as
their insurer
 Who do not have a demonstrated need for
programmed dosing
 Who do not follow a rigid schedule every
day
 Have HMO Medicare: Costs May Not Be
Covered-check with the intermediary

28. Pump Refill Considerations
 Meds to refill the pump may have
acquisition costs of $20-$500 per refill
or much higher for Prialt
 Pump refill kits range from $15-$35 per
refill
 Shorter refill times in cancer patients
 Longer refill times in those with chronic
pain on stable therapy
 Pump delivery is 10% plus or minus
 Transportation vs. Home Refill

29. Importance of Trial
 Next to psych eval, trial is most important
feature leading to intrathecal implantation
 Adequate pain reduction
 Increase functionality
 Lack of significant side effects

30. Acceptable Risk Ratio
 Severe Pulmonary disease patients may
pose intraoperative risks but less long
term risk vs. Oral narcotics
 Uncontrolled diabetes patients will not
heal from implantation.
 Adequate anticoagulation reversal
 Patient accepts risks of bleeding,
infection, neurological injury,
inadequate pain relief, need for revision
surgery.

31. Serious Risk: Catheter Granulomas in Patients
 Neurosurgery. 2002 Jan;50(1):78-86;
discussion 86-7. Inflammatory mass
lesions associated with intrathecal drug
infusion catheters: report and
observations on 41 patients. Coffey RJ,
Burchiel K
 30 of the 41 underwent surgery for
cauda equina syndrome, 11 of these
were non ambulatory afterwards
 Only seen with narcotic infusion

32. Chronic IT MS Infusions
Produce Significant Side
Effects in Sheep
 MS IT sheep infusions 12-18mg/day produce
inflammatory masses extending the length of
the catheter and hindlimb deficits in 2/3 of
sheep. 6-9mg/day produced 5cm inflammatory
mass; 3mg/day produced no inflammation.
Anesthesiology. 2003 Jul;99(1):188-198. Safety of
Chronic Intrathecal Morphine Infusion in a Sheep Model.
Gradert TL, Baze WB, Satterfield WC, Hildebrand KR,
Johansen MJ, Hassenbusch SJ.

33. Tolerance is the Norm-IT
Infusions Do Not Eliminate the
Need for Escalating Doses
 Mean MS dosing increased from 1.2mg to
5.1mg after 24 months J Pain Symptom Manage.
2001 Oct;22(4):862-71. Long-term intrathecal infusion of
drug combinations for chronic back and leg pain.
 Mean MS dosing increased from 1.1 mg to
3.1mg after 6 months Surg Neurol. 2001
Feb;55(2):79-86; discussion 86-8. Continuous intrathecal
morphine treatment for chronic pain of nonmalignant
etiology: long-term benefits and efficacy. Kumar K, Kelly
M, Pirlot T.

34. Neuraxial
Screening
Trials

35. There Are Mixed
Signals as to What
Constitutes the
Most Appropriate
Intrathecal Trial

36. Screening Trials
 Last step in patient selection process
 Performed by admin. Intraspinal MS,
hydromorphone, or sufenta via lumbar puncture
or percutaneous catheter
 Bolus or continuous infusion
 Paice et al.> Most common:continuous epidural
infusion (35.3%), intrathecal bolus (33.7%),
bolus epidural (24.5%). Least common:
continuous intrathecal infusion 6%
 Paice JA, Penn RD, Shott S. Intraspinal morphine for chronic pain: a retrospective, multi-center
study. J Pain symptom management 1996;11:71-80.

37. Purpose of Trialing
 Eliminate placebo effect
 Access side effect profile
 Determine optimal starting dosages
 Provide satisfactory response

38. Satisfactory
Patient
Response
is the
Most
Important
Element
of the
Trial

39. Other Purposes of the Trial
 Allow the Physician to Observe the Patient
Response
 Permits the patient to experience the
feeling of intrathecal infusion and side
effects

40. Medical-legal:
Appropriate
trials can
reduce the risk
of having to
swim with the
sharks later

41. Advantages &
Disadvantages IT/Epidural
 Advantages
 Intrathecal
 Replicates system to be
implanted
 Better predictor of
efficacy
 Epidural
 Less invasive
 No post dural puncture
headache
 Less chance of
meningitis
 Disadvantages
 Intrathecal
 Risk of postdural puncture
headache
 More invasive
 Risk of spinal-cutaneous fistula
 Epidural
 May observe more adverse
events due to higher dose
 Potency of epidural opioids is less
than for intrathecal opioids
 Systemic absorption very
high

42. Screening Trials Criteria
 Not have benefited satisfactorily with optimal
medical management
 More conservative measures ruled out
 Different methods available but should
address:
 Does the patient have side effects with the
administered drug that would
contraindicate the therapy?
 Does the patient demonstrate adequate
pain relief?

43. Screening Criteria
(Tutak & Doleys)
I. At least 50% relief of pain during the trial**
II. Discontinued use of systemic narcotics during
the trial
III. Increased activity level or decreased level of
discomfort at typical activity level
IV. Absence of untoward side effects
V. Absence of significant psychopathology
VI. Appropriate expectations
Tutak U, doleys DM: Intrathecal infusion systems for treatment of chronic low back and
leg pain of noncancer origin. Southern Medical J 89:295, 1996.
** Note Overt Withdrawal Syndrome will Occur if Oral Meds Discontinued During
Sufentanil or Fentanyl Intrathecal Trials

44. Approaches
 Single Bolus (Epidural vs. intrathecal)
 Multiple bolus injections
 Placebo
 Epidural or intrathecal
 Catheter
 Continuous with external pump (epidural
or functional intrathecal trial)

45. Catheter Screening
Techniques
 Percutaneous (Epidural & Intrathecal)
 Most frequently used
 Paramedian approach
 Catheter placement, tunneled subcutaneously
 Surgical-Permanent Catheter Implanted at
the Time of the Trial
 Avoids instrumenting the spine twice
 Use of second disposable tunneled catheter
 Use only if you are really really sure...

46. Patients
Don’t
Like
Surprises
(so do a good trial
to prove to the
patient exactly how
the infusion will feel)

47. Time Trials for Potential Pump Patients:
Functional Intrathecal Trials

48. Intrathecal Infusions (Deer et al.)
 Oral MSO4 (Ms) dose titrated down prior to
initiation
 Implanted tunneled catheter below costal margin
 External pump with MSO4 @ 0.5-1.0mg/d;
increased @ 1 mg/day until 50% relief
 Oral MS decreased 50% on first day for 3 days
then stopped
 Co-medication with metoclopramide and laxatives
 Pain diary kept of VAS; successful if > 50% for 3
days
Deer T, Winkelmuller W, erdine S, Burchiel K. Intrathecal Therapy for cancer and nonmalignant pain:
patient selection and patient management. Neuromodulation 1999;2:55-66.

49. Advantages of Functional
Intrathecal Trials (FIT)
 Physician will know exact starting dose
to be placed in intrathecal pump which
eliminates need for post-permanent
implant hospitalization
 Patient knows exactly what they will
obtain in the way of pain relief
 Outpatient IT trial is used to determine
effects of ADL on pain
 Patients are usually opiate effect
tolerant

50. Disadvantages of FIT
 Infection/meningitis risk
 Post dural puncture headache 5-20%
 Patients may not recognize significant side
effects
 System must be closed and not re-opened
(eliminates multiple drug possibilities)
 Limited timeframe (Some physicians are using
up to 2-4 week functional intrathecal trials
 Use of IT sufenta during oral opiate reduction
for the trial may induce a full blown narcotic
withdrawal syndrome

51. FIT Screening Devices

52. How to Conduct FIT Safely
 Scrupulous skin preparation
 Antibiotic IV 30-60min prior to insertion and
follow-up for 10 days with antibiotic
 19ga wire wound epidural catheter placed
intrathecally-tunnel the catheter
 Use lumbar placement unless pain is
cervical and sufenta is the opiate chosen
 External infusor at 0.1-2 cc/hr
 Superglue all connections together
 Average 5-7 day trial- Bolus in OR

53. Fluoroscopic Placement of IT Needle

54. IT Catheter Advancement

55. Fluoroscopic Catheter Placement

56. Incision at Needle Entry Site

57. Stitch Placed Across Incision

58. Metal Stylette or 20ga Needle
Tunneled From Incision Site Laterally

59. Epidural Needle Removed then
Placed End to End with Stylette

60. Advance Epidural Needle Over Tip of
Stylette to Avoid Catheter Laceration

61. Once Epidural Needle is Advanced
to Central Incision, Thread Catheter
Through the Epidural Needle

62. Catheter Buried Under Suture

63. Epidural Needle Retracted

64. Central Incision Closed-Prior Stitch
Placement With Protected Catheter Avoids
Pithing Catheter Later with Needle

65. Knot Tied In Catheter

66. Catheter Loop Stitch to Skin

67. Final View
Central Incision
Intrathecal Catheter

68. Dressing, Filter,
Connect to
External Pump,
INSTRUCTIONS!

69. There is a significant cervical-lumbar
concentration gradient for hydrophilic
compounds
 Using hydrophilic Indium labeled DETAPA, the T2
concentrations were only 42% as high as the T12
concentrations after lumbar boluses in humans
Neurosurgery. 1993 Aug;33(2):226-30
 In another study, the ratio of high cervical vs. Low thoracic
concentrations of morphine was 21% following a single bolus.
The same percentage for meperidine was 10%. Anesthesiology. 1985
Nov;63(5):483-9. Distribution of morphine and meperidine after intrathecal administration
in rat and mouse. Gustafsson LL
 Another study demonstrated no cisternal
methadone after lumbar injections.

70. PCEA: Continuous Epidural Infusion
Trials
 Arrow Flextip Catheter
 Outpatient vs. 23 hour stay
 Local anesthesia with iv sedation
 Fluoroscopy
 Epidurogram; contrast non-ionic ONLY!
 Cervical v Thoracic v Lumbar
 Tip location
 Tunnel catheter
 0.22 micron filter
 Microject Infusion PCEA pump

71. Outpatient Continuous
Epidural Infusion Trial
 Long term 1-4 weeks
 Patient returned to usual , familiar
environment
 Less cost $$ than inpatient
 Increase specificity/selection?
 Patient satisfaction
 Greater control
 Medicare may not reimburse enough to
cover outpatient trial costs

72. PCEA Trial Dosing and Setup
J Patrick Couch, MD
 23hr observation/Outpatient trial
 Initial dose equivalent to daily oral dose
 Reduce oral dose by 50% initially to
prevent withdrawal
 Continue oral taper by 15-20%/day
 Increase infusion by 25-33% q 24 hrs until
pain relief >50%

73. Protocol
 Set initial infusion at 0.3-0.5cc/hr.
 PCEA mode:
 -10%
 -30 min –1 hr lockout
 Physician judgment
 Duration
 1-4 weeks
 Antibiotic prophylaxis x 2 weeks

74. Disadvantages to PCEA Trials
 Yaksh demonstrated in 1986 that the
fraction of epidural morphine crossing the
dura after single injections is only 0.31%
(Anesthesia & Analgesia, Vol 65, 583-592)
 There is no direct correlation between
epidural and intrathecal opiate doses
 Major effect may be systemic since
concentrations of the systemic drug may be
high

75. Problems with Continuous Epidural
Trials
 CSF and plasma MS concentrations 60 min after
epidural installation are equal. Concentrations in CSF
are 4-8 times higher with epidural vs IM injection
Pharmacol Res Commun. 1985 Feb;17(2):189-96.
 Sufentanil blood levels were equal for epidural vs IV
infusions with same pain control Anesthesiology.
1994 Aug;81(2):346-52; discussion
 Fentanyl blood levels during continuous epidural
infusion produced a steady rise in blood
concentrations to produce hypoxia after 48 hours.
Pain control was no different than IV fentanyl infusion.

76. Complications Of Continuous
Trial Systems (FIT and Epidural)
 Patient Related-incompetent patients, inability to
articulate pain, inability to comprehend
instructions, risks due to patient at home
 Surgical
 Infection
 Bleeding
 Dural puncture headache/CSF leak
 Tissue breakdown
 Device-Related
 System malfunction
 Catheter migration/obstruction
 Pain caused by system placement

77. Complications of Continuous
Trial Systems (Cont’d)
 Infusate-related
 Dosage miscalculation
 Overdosage
CATHETER BREAKAGE CAN OCCUR ON
REMOVAL! Usually this occurs in the tunnel
and it is easy to remove the stitch from the
spinal wound and extricate the remaining
catheter

78. Not All Trials Give the Desired Result

79. Single Bolus Trials
 NPO 6 hours
 Informed consent
 IV access
 Bolus injection based on oral equivalent dose
 Monitor for 12 hours (23 hour observation) This may be waived
in healthy opiate tolerant patients
 Disadvantages: 1. High concentrations opiates may produce
side effects, but it is not certain these will abate over time after
implant 2. Lack of continuous infusion does not adequately
test real life conditions, insidious side effects such as pedal
edema, severe constipation, sedation 3. Patient cannot detect
problems with either pain control nor side effects when not at
steady state

80. Effect of IT vs IV MS on Ventilatory
Response to Hypoxia
NEJMVolume 343:1228-1234 October 26, 2000
0
5
10
15
20
25
30
35
40
45
Placebo MS IT
30 min
12 hrs
 MS IV dose was
0.14mg/kg
 MS IT dose was 0.3
mg/kg
 12 hour respiratory
depression remained
significant
 However, these were
not opiate tolerant
patients
Liters/min

81. Predictive Value of Single Shot
Intrathecal Opiate Trials Pain Practice Dec
2002
Dominguez, et. al
 Three groups of responders: 0.25mg
(low dose), 0.5mg (standard dose),
1mg (biggie size) MS used or equiv.
 Patients were followed both by
diagnosis and by intrathecal dose
escalation after implantation of pump
 Dose equivalencies were determined
using a Texas Tech IT opiate
equivalency scale

82. Dose Escalation for the 3
Groups
Dominguez, et al Pain Practice Dec 2002
0
5
10
15
20
25
30
35
Initial 6 mos 12 mos 18 mos 24 mos
mg/day
High Dose
Standard
Low Dose

83. Dose Escalation vs. Disease
Dominguez, et al Pain Practice Nov 2002
0
10
20
30
40
50
60
70
Initial 6 mos 12 mos 18 mos 24 mos
mg/day
Cervicalgia
Visceral
Deafferentiation
Chronic Low Back
Peripheral
Neuropathy

84. Prospective Randomized Trial of
IT single shot vs Epidural
Infusion for IT Pump Implant
Valerie Anderson et al Neuromodulation July 2003
 67% of IT single shot patients had
relief>50% and underwent implant
 79% of CEI patients had relief >50% and
underwent implantation
 6 month successful pain relief was 60% in
both groups
 No difference in pain rating, quality of life,
mood, or function after 6 months
{37 patients total in trial}

85. The Dark Side of Trials

86. Complications Rates
(Dahm et al.)
 Epidural vs. Intrathecal
 No difference re. Skin breakdown or local infxn.
 Deep infections
 -epidural 6%
 -intrathecal 1%
 Catheter dislodgement, leakage and obstruction
was sig. Higher in the epidural group
 Meningitis rare in epidural trials, more common
in intrathecal trials
 Dahm P, NitescuP, Appelgren L, et al. Efficacy and technical complications of long-term continuous
intraspinal infusions of opioid and/or bupivicaine in refractory nonmalignant pain: a comparison
between the epidural and the intrathecal approach with externalized or implanted catheters and
infusion pumps. Clin j Pain 14:4-16, 1998.

87. Surgical Techniques

88. Key Issues of Surgical Technique
 Planning
 What to implant (i.e., type of device)
 Where to implant it
 Preparation
 Asepsis and antibiotics
 Performance
 Incision
 Dissection
 Closure

89. Intrathecal Infusion Pump
Considerations
 Programmable vs Non Programmable
 Differing reservoir sizes (chronic non-malignant
pain- usually the larger the better)
 Pump morphology: Codman is flying saucer
shape, Medtronics is cylindrical
 Anchoring Loops vs no loops
 Catheter access port vs none (always use a
pump with a catheter access port for chronic
non-malignant pain)
 Cost: Programmable costs 40-90% more than
non-programmable- Refill costs considerations

90. 50cc, 30cc, 16cc
0.3-2cc/day
28cc-0.4cc/day
18cc, 10cc
20, 35, 60cc
0.3, 0.5, 1.0, 1.5, 4cc/day
“Know
Thy
Pumps”
Michael 5:15
20cc, 40cc

91. Decision Making Algorithm on Pump
Location
Morbid Obesity Normal Hypersthenic
Anatomic Preclusion to Implant: Colostomy, Planned abdominal surgery,
severe scar tissue, etc
Yes
No
Consider
Posterior
Implant
Lateral
Sleeper
Supine
Sleeper
Contralateral
Abdominal Wall
Implantation
Right Abdominal
Wall Implantation
Consider small
Pump or submuscular
Fascia implant anteriorly
Contralateral abdomen
Implant, posterior
Implant, or possibly
small pump in thigh
After the above,
have patient show
where they would
like the pump

92. Catheter Placement Considerations
 Granuloma formation with
catheter tip in the thoracic spine
is a real and potentially
devastating possibility
 Location of pain: cervical,
thoracic, lumbar, abdominal,
global
 For cervical tip placement, risk of
long subarachnoid catheter from
the lumbar spine vs risk of a
cervical subarachnoid puncture.

93. Lipophilicity of Infused IT
Medications
 Lipophilicity of the drug:
MS 1.42 Baclofen1.56 Dexmedetomidine 2.89
Meperidine 38 Alfentanil 130
Hydromorphone 525 Bupivicaine 560
Fentanyl citrate 816 Sufentanil 1727
There were some studies demonstrating a much higher coefficient for
bupivicaine (around 1500). Values for clonidine were not found but may be
close to dexmedetomidine
 Above values are octanol:water partition coefficients

94.  No fusion in the area of lumbar needle
placement and lumbar catheter placement:
MAC/Spinal/General
 Fusion in area of lumbar needle placement,
non-lumbar needle placement, catheter
advancement to thoracic or cervical regions:
MAC for catheter advancement then GA for
remainder
 TIGHT BLOOD SUGAR CONTROL DURING AND
AFTER SURGERY IN DIABETICS LOWERS
WOUND INFECTION RATES BY 66%. (Endocr Pract.
2004 Mar-Apr;10 Suppl 2:21-33)
ANESTHESIA CONSIDERATIONS:

95. Antibiotic Coverage and
Prep
 IV antibiotics (cefazolin 1g, levaquin 500mg)
30-60 min before initial incision. DO NOT
COMPROMISE ON THIS POINT
 Everyone in the OR wears a mask on entry
 Surgical hand wash
 Surgical scrub then prep
 Double glove for draping, then shed outer gloves
 +/- Ioban
 C-arm drape

96. Planning
 “Decision before incision”
 Select appropriate device-patient may help
with this-give them a model preop
 Select appropriate implant site
 Incision location
 Minimize scar appearance
 Incise along “relaxed skin tension lines,” NOT
across skin creases
 Minimize interference with function
 Locate pump away from ribs and iliac crest

97. Asepsis
 Aseptic technique
 Minimize handling of implanted devices
 Consider “no touch” technique
(e.g., use forceps to handle catheter)
 Consider “double gloving” with color
undergloves
 Breached surgical gloves are observed in surgical
team members in up to 30% of CSF shunt
surgeries

98. General Surgical Principles
 Minimize tissue trauma
Be gentle (Do unto others as you would have
them do unto you)
 Use appropriate size instruments
 Grasp skin edges gently
(dermis, not epidermis)
 Achieve careful hemostasis
 Bleeding reduces visibility, promotes infection,
delays healing- but do not use electrocautery
excessively

99. Incision
K. Follette, MD
 Hold knife however you prefer but incise
perpendicular to skin
From Sherris and Kerns, Basic Surgical Skills, 1999

100. Incision and Dissection
K Follett, MD
 Know your tissue layers
Pump
pocket goes
here
Anchors
go here

101. Closure
 For best closure, select appropriate
sutures and needles
 Tapered needle for “soft” tissues
 “Cutting” needle for “firm” tissue
(e.g., skin)
From Sherris and Kerns, Basic Surgical Skills, 1999

102. Sutures
 Types of suture
 Absorbable 120 day or less strength
 Minimal long-term inflammatory response
 Lower infection risk?
 Non-absorbable (may last many years)
 Greater longevity (e.g., for anchors and connecting parts)
 Braided
 Easy to tie, holds knots
 Monofilament
 Lower risk of infection?
 More difficult to tie

103. Suture Materials
From Sherris and Kerns, Basic Surgical Skills, 1999

104. Staying Power of Sutures

105. Suture Materials
From Sherris and Kerns, Basic Surgical Skills, 1999

106. Time after surgery (weeks)
0 6
%
normal
tissue
strength
100
suture strength
tissue strength
total wound strength
Suture must provide wound strength until tissue heals

107. Infection Risk of Suture

108. Closure
 Technique
 Obliterate dead space (pocket should hold
pump without tension but not be too large)
 Undermine to reduce tension on skin closure
 Approximate skin edges to promote healing
and minimize infection and wound breakdown
risk
 Approximate, don’t strangulate !

109. Deep Closure
From Sherris and Kerns, Basic Surgical Skills,
1999

110. Skin Closure
From Sherris and Kerns, Basic Surgical Skills,
1999
Approximate,
don’t strangulate

111. Surgical Instruments
Gelpi
Retractor
Weitlander
Retractor Adson Toothed
Forceps
DeBakey
Forceps
(No teeth)
Curved Metzenbaum
Dissecting Scissors
“Metz”
Kocher Clamp
With Teeth
Mayo
Scissors
Mosquito
Hemostat
Allis Clamp

112. Surgical Sequence
 Spinal Incision midline, slight paramedian needle
placed into CSF, thread catheter, open pump for
prep, placement of anchor stitch +/- purse string
stitch in ISL, abdominal incision, pocket creation
with fascial exposure, fascial non-absorbable
anchor stitches, tunneling, remove spinal needle
and catheter stylette, anchor catheter.
 Pass catheter to abdominal wound, trim catheter
and pass off trimmed section for measurement,
connector application, connect and secure to
pump, insert pump +/- Dacron pouch, suture
pump to fascia with excess catheter coiled
beneath pump, wound irrigation, layered
interrupted stitch closure, bolus in OR

113. Scrupulous Sterile
Technique and Draping

114. Local Anesthesia
Before Incision

115. Option: If IT Access Is
Anticipated to be Difficult,
Use Fluoro and Place Needle
First

117. Electrocautery for Hemostasis in Spread
Wound: Do NOT touch epidermis with
active electrocautery

120. HINT: CSF Is Easier to Obtain In the
Lateral Position with 20 deg Reverse
Trendelenburg

121. Advance Catheter Under Fluoroscopy
And Do NOT Pull Back On a Silastic
Or Soft Catheter (Shearing)

122. Epidurogram Myelogram
Use Low Volumes Non-Ionic Contrast
(Omnipaque or Isovue) for
intraoperative myelogram. Be very
careful with cervical catheter
placement to use low volumes and
Keep HOB elevated

123. Options: Anchor Stitch in ISL or SSL, Double Anchor
Stitches, Anchor Plus Purse-string Suture

125. Use Manual Traction and
Countertraction During the
Incision. Pocket Length Is 1cm
Longer than Pump Diameter

126. 2/3 of Pocket Is Developed
Inferior to the Incision to
Prevent Scar Formation
Directly Over Fill Port

127. Allis Clamp Used to Hold the Dermis
(not the epidermis) in Preparation
For Undermining the Tissues

128. Lateral Dissection with Electrosurgical Cut
Is Rapid but More Hazardous than Other
Techniques

129. Manual Finger Dissection Creating
Pump Pocket. Other Options Include
Metzenbaum or Electrocautery
Dissection

130. Non-absorbable
Heavy Gauge
(size 0) Used
To Anchor
Pump to the
Fascia
(Ethibond)

131. Passage of Tunneling
Device using Digital
Contact with Tip
During Advancement

133. Removing the Stylette
(Hold the
Catheter and Gently,
Slowly Remove
The Stylette Using
Steady Retraction)
Remove Epidural Needle
Anchor to SSL or ISL

134. Passage of Catheter
Through Tunneling
Device

135. Free flow of CSF Should Be Seen.
If Not, Aspirate to Confirm

136. Layered Closure with Interrupted
Deep Layer Stitches

137. Skin
Closure
Is
Interrupted
Horizontal
Mattress
Stitch

140. Remove
Guard
To Connect
Catheter

141. Secure the Pump
to the Fascia with
the Non-absorbable
Fascial Stitches

142. Pump Should Not Be Too Tight in Pocket:
If So, Remove Pump and Expand the
Pocket Size Slightly. The Skin Should
Close without Tension

144. Post Op Care
 Bolus may be given in PACU
 No immersion bathing or showering until return
for suture or staple removal
 No bending over forward or excessive lifting until
cleared
 Tight control at home of diabetes
 Continued oral antibiotics
 Contact number where physician may be
reached for fever, edema, erythema, excessive
drainage, nuchal rigidity, changes in mentation
 Follow in office in 7 days for wound check
 Stop oral narcotics based on bolus timing

145. Troubleshooting and
Complications
of Intrathecal Infusion Pumps

146. “Itcouldbethatthepurposeofyourlifeis
onlytoserveasawarningtoothers”

147. Intraoperative
Complications
of IT Infusion
Pump
Implantation

148. I. Intraoperative Complications
 Catheter Sheering
 Inability to locate subarachnoid space
(stenosis, position, etc)
 Intra-abdominal tunneling (into abdomen)
 Extremely deep fascia (anchoring issues)
 Prior surgery (may not be evident where
fusion mass exists)
 Spinal cord damage due to passage of
catheter (cauda equina or syrinx formation)
Reg Anesth Pain Med. 2004 Nov-Dec;29(6):606-9.- syrinx reference
 Catheter obstruction (kinking or tie)

149. Intraop Neurological Complications
 Types: Root, cauda equina, spinal
cord
 Incidence <1% permanent
 Transient root irritation in up to
8% with some paresis in up to 8%
 Etiology: Traumatic placement of
catheter, inability to easily
advance catheter, high needle
placement
 Survey of 519 implanters: 35
patients with these problems

150. New Major Neurological Deficit
In PACU
 MRI with contrast lumbar/thoracic spine to rule
out epidural hematoma or cord damage. This
must be done immediately.
 Early EMG within 2 days may be useful as a
baseline study
 Early consultation with neurosurgeon or
neurologist is preferred
 Do not inject local anesthetics intrathecally
during the pump implant or during the trial to
avoid confusion of drug effect vs complications.

151. Pulling Back on the Catheter
May Produce Sheer

152. Difficulty in Accessing CSF
Tumor, spinal stenosis, etc.
Myelogram blockage L2
(Tumor)

153. Extremely Deep Fascia

154. Solutions:
 Use very long sutures between the pump
and the fascia (0-Ethibond)
 Use a Dacron pouch into which grows
fibrous tissue from the body and
stabilizing the pump location
 No pouch, no sutures. Secure by making
a snug but not too tight subcutaneous
pocket.

155. Fusion Nightmares
Solutions:
1. Enter at thoracic
level
2. Enter caudal level
through the
sacrococcygeal
ligament
3. Retrograde thoracic

156. Trauma Due to Catheter
Passage

157. Catheter kinking/separation
Fissure in Connector
Permitting Catheter
Disconnection

158. Avoidance of Kinking/disconnect
at time of Implantation
Non-Kinking Titanium
Wire Reinforced Cath Intraoperative
Myelography
Avoid overtightening
or suture strangulation of
catheter. Scrupulous
detail at catheter
connections

159. Radiocontrast Reactions
 Immediate: anaphylaxis
 Use non-ionic contrast only:
Omnipaque 240 or 180, Isovue M.
Never ever use conray or ionic contrast.
 Presentation: paresthesias, ascending
tonic-clonic spasms, generalized
seizures, respiratory compromise,
metabolic acidosis, rhabdomyolysis,
coma, death
 Incidence rare but take iodine allergies
seriously

160. Death Due to Delayed Contrast Transfer
Into the Brain After Movement of a
Morbidly Obese Patient to a Gurney s/p
T11 Contrast Placement

161. II. Early Complications after Implant
 Epidural Hematoma
 Post Operative Seroma Formation
 Bleeding from abdominal
or spinal incision Local skin infection
 Edema of skin over pump
 Wound dehiscence
 Inadequate analgesia
 PDPH with CSF leak
 CSF Hygroma
 Drug Overdose

162. Seroma Formation
 Not uncommon-serosanguinous straw colored
 Fluctuance over intrathecal pump with edema
 No erythema, usually very little drainage
 May be quite large 200-300cc
 DO NOT TAP UNLESS ABSOLUTELY NECESSARY
 Compression bandage to treat
 Avoidance through not using
excessively large pocket for
pump. Measure the pump.
 Abdominal binder on all patients

163. Seroma Fluid Aspiration

164. Wound Dehiscence
 Systemic factors: Age older than 65
years, hypoalbuminemia, obesity, uremia,
malignancy, systemic infection,
hypertension, Cushing disease, thyroid
disease, liver disease, and congestive
heart failure, tobacco use, steroids, ASA
can predispose to wound dehiscence. the
risk of dehiscence.
 Inadequate surgical technique:
crushing of tissue, excessive
electrocautery, ineffective
hemostasis, dead space in the
wound, excessive wound
tension, and overly tight sutures.

165. SUPERFICIAL WOUND
INFECTION (1-10% incidence)

167. EDEMA
Purulence
ERYTHEMA

168. AVOID THIS: EXPLANT NECESSARY
65-85% of Infections associated with Pump
Implants are in the Pump Pocket

169. Avoidance of Wound Infections
 Do not operate with FUO or elevated WBC
 Prophylactic antibiotics (eg. Cefazolin,
Levaquin)
 Avoid skin shaving (clip if necessary)
 Scrupulous skin prep
 Meticulous sterile technique
 Approximation of skin edges
 Avoidance of crushing skin edges
 Minimal electrocautery use but effective
hemostasis
 Smallest sturdy caliber of suture

170. More avoidance of infection
 Monofilament sutures
 Antibiotic timed one hour before beginning
of procedure
 Sufficiently snug closure to avoid
hematoma or seroma formation
 Use currently recommended prophylaxis
from infectious disease in your hospital
 Use tight control of blood sugar in
diabetics pre, intra, and post op x 1 week

171. the usual suspect
Some Hospitals Have A MRSA Rate Approaching 90% of
All Staph Infections: Try Avoiding Implants In These
Hospitals

172. Staphylococcus epidermidis

173. E. Coli

174. Treatment of Infection
 Sterile Q tip exploration of open
wound...if subcutaneous layer is intact,
pack wound with sterile gauze and
change 2x daily
 If subcutaneous layer is open, then I and
D in the OR with a pulsation irrigation
system with bacitracin 50,000U per liter
saline
 Culture at time of probing
 Appropriate antibiotic therapy
 Explant if pocket infected or deep spinal
wound infection

175. If the pump pocket is infected, explant.
Cultures preop via pocket aspiration or
intraoperative gram stain

176. Post Operative Bleeding

177. Avoidance of Post Op Bleeding
 Preoperatively stop anticoagulants 72-
96 hours, NSAIDs 3-4 days; ASA, Plavix,
Ticlid, garlic, ginsing, vit E- 10 days;
ginko 24 hours
 Dry field before closing
 Use layered interrupted suture closure
including skin
 Approximation of skin edges
with mattress stitch

178. Treatment Post Op Bleeding
 Pressure dressing
 Reassurance
 More frequent monitoring for the terrible
tetrad of hematoma, infection, necrosis,
dehiscence
 May require evacuation if continued
expansion occurs

179. “Nurse Wright, when I givethe signal, you slap
that Band-Aid on him as fast as possible”

180. Hematoma:
Early-semigelatinous
Late-solid
Edema, raised area,
often
bluish discoloration.
No increased temp of
wound

181. ULTRASOUND OF
SUBCUTANEOUS HEMATOMA
(No Pump is Present)

182. Post Dural Puncture Headache
 Loss of CSF at time of implant or from
persistent CSF leak
 Positional headache with or without
abducens nerve traction symptoms
 Incidence approx 15% severe
 Immitrex is a good first choice
 Consider blood patch but only if
absolutely necessary: consider adjacent space
entry

183. Persistent Leaks: Spinal-Cutaneous
CSF Leak
 Continued CSF
Drainage from
Wound
 More Common
After Old Spinal
Catheter Removal
 Options: Time or
Epidural Blood
Patch
 Do Not Probe
Wound
 Lying Supine May
Help Slow Leak

184. CSF Hygroma
 Persistent CSF leak into subcutaneous
tissues causing a subcutaneous
collection
 May be confused with seroma
 Incidence 0.5% with purse-string suture
(Naumann), 0.5%-8% without
 May persist 4 weeks
 Treatment: compression dressing, tap
only if concerned about infection
 Caudal catheter blood patch may be
helpful

185. Early Fascial Stitch Rupture Caused Frequent Pump Rotation
With Subsequent Torque At Connection and CSF Hygroma

186. Epidural hematoma
T9-12
*RAPID ONSET OF
Myelopathic symptoms
and/or radicular symptoms
*Usually within hours
*Incidence <1%
*Treatment: Emergent
surgical decompression
EPIDURAL
HEMATOMA

187. IT Drug Overdose
 Whereas there are only 4 reported cases of post
intrathecal injection seizures after morphine,
there are many cases of improper drug dosing
resulting in early somnolence, respiratory
depression, and death
 These may occur in the PACU
 Do not ever permit a nurse or tech to access the
bolus port without your immediate presence and
direction…nurses should absolutely never ever
inject contrast into the bolus port, however
there are some currently doing this.
 Check the programming personally to make sure
there is no overdose when giving an initial bolus.

188. Long Term Side Effects Are Possible
from Intrathecal Infusion Therapy

189. III. Late Complications
 Pump Malfunction (battery depletion, clogged
internal filter, gear 5 dysfunction, MRI exposure >
1.5 Tesla, leaky access port, mis-programmed)
 Pump migration (flipped pump or pump migration
due to increased or decreased weight )
 Epidural abscess
 Catheter disconnect or kinking
 Catheter penetration (from needles or surgery)
 Catheter migration (from intrathecal CSF)
 Spinal granuloma formation
 Seeded infection

190. Sudden Onset Generalized Severe
Pain and Withdrawal Symptoms
 If Recent Refill, check invoice on drug
 Query program to insure is correct
 Simultaneous Check of Reservoir Volume
and Pump Myelogram or Indium Scan
 If catheter system is intact, then do a rotor
study if Indium reservoir scan above not
performed (takes 3 days) or in a non-
programmable pump perform serial residual
volume checks.
Proper Medication is Not Reaching Spinal Receptors

191. Trouble shooting: Catheter
 Break
 Kink
 Disconnection
 Dislodgement

192. Indium Scan
 Inject 0.55 mCi of
Indium 111 into pump
reservoir
 Obtain scan
 Repeat scan at 2 or 3
days
Normal Indium Scan

193. Trouble shooting-Catheter
Initial
Leakage
3 Day

194. Trouble shooting
(Indium Scan)
Occlusion

195. New Severe Low Back or Mid
Back Pain with Myelopathy
 MRI lumbar spine to rule out epidural
abscess, new lumbar disc problem or
spondylolisthesis, arachnoiditis, spinal cord
infarction, and granuloma of the spine
 C-reactive protein, ESR, and CBC useful

197. Epidural abscess
L4-5 with disciitis
Epidural Abscess:
-Intense back pain midline
-Slight or normal elevation
of WBC
-Elevated C reactive protein
-MRI diagnosis

198. Inflammatory Mass (Granuloma)
• Associated with high
concentration or high dose
intrathecal opioid
Presentation: loss of
analgesia, new pain +/-
neurological deficits
Has not been described in
patients receiving baclofen
alone

199. Inflammatory Mass
(granuloma)

201. Inflammatory Mass
 Recommendations for the diagnosis, treatment, and prevention of
catheter-tip granuloma formation
 Diagnosis
 1. Document a thorough baseline evaluation.
 2. Document three-dimensional location of the intrathecal catheter
tip at implantation.
 3. Provide attentive follow-up and remain alert to diminishing
analgesic effects, loss of previously satisfactory pain relief,
remarkable or unusual increases in the patients underlying pain,
steep or frequent dose escalations, or neurologic symptoms
suggestive of an inflammatory mass.
 4. Have a low threshold of performing contrast-enhanced T1-
weighted MRI or CT-myelography.

 Treatment
 1. Mildly symptomatic patients can be treated conservatively by
drug cessation through the catheter into the mass.
 2. Patients with severe neurologic symptoms should have a
neurosurgical consult and possible neurosurgical removal of the
mass. Hassenbusch S et al: Management of Intrathecal Catheter-Tip Inflammatory Masses: A
Consensus Statement. Pain Medicine 2002;3(4):315-323

202. Inflammatory Mass
Prevention
1. Consider placement of the catheter tip in the lumbar
thecal sac.
2. Keep the drug dose and concentration as low as
possible for as long as possible while still achieving
adequate analgesia.
Hassenbusch S et al: Management of Intrathecal Catheter-Tip Inflammatory Masses:
A Consensus Statement. Pain Medicine 2002;3(4):315-323
In dog studies, addition of clonidine appeared to markedly
reduce the incidence of inflammation due to morphine

203. Catheter Granulomas in
Patients
 Neurosurgery. 2002 Jan;50(1):78-86;
discussion 86-7. Inflammatory mass
lesions associated with intrathecal drug
infusion catheters: report and
observations on 41 patients. Coffey RJ,
Burchiel K
 30 of the 41 underwent surgery for
cauda equina syndrome, 11 of these
were non ambulatory afterwards
 Only seen with narcotic infusion

204. Chronic IT MS Infusions
Produce Dose Related
Significant Side Effects in
Sheep
 MS IT sheep infusions 12-18mg/day produce
inflammatory masses extending the length of
the catheter and hindlimb deficits in 2/3 of
sheep. 6-9mg/day produced 5cm inflammatory
mass; 3mg/day produced no inflammation.
Anesthesiology. 2003 Jul;99(1):188-198. Safety of
Chronic Intrathecal Morphine Infusion in a Sheep Model.
Gradert TL, Baze WB, Satterfield WC, Hildebrand KR,
Johansen MJ, Hassenbusch SJ.

205. IT MS Produces Motor Deficits and
Inflammatory Masses on the Spinal
Cord in Dogs
Anesthesiology. 2003 Jul;99(1):174-187. Chronically Infused Intrathecal Morphine
in Dogs. Yaksh TL, Horais KA, Tozier NA, Allen JW, Rathbun M, Rossi SS,
Sommer C, Meschter C, Richter PJ, Hildebrand KR. Beagles with 28
day infusions of morphine intrathecally developed
motor deficits and inflammatory masses which
were dependent on the amount of morphine
infused. All animals with 12mg/day developed
significant inflammatory masses and many had
motor deficits. Allodynia developed almost immediately on
initiation of infusion. Clonidine co-infusion seemed to supress
the development of the inflammatory mass.

206. Pain Med. 2004 Mar;5(1):14-25. Continuous intrathecal infusion of
hydromorphone: safety in the sheep model and clinical implications. Johansen
MJ, Satterfield WC, Baze WB, Hildebrand KR, Gradert TL, Hassenbusch SJ. Department of Experimental
Therapeutics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030-4009, USA.
OBJECTIVE: To determine the safety of hydromorphone delivered by continuous intrathecal infusion via
implanted delivery systems in sheep. DESIGN: Sheep implanted with intrathecal infusion systems were
randomly assigned to receive either 1.5, 3, or 6 mg/day hydromorphone HCl or saline control (3 sheep/dose
level) at a fixed infusion rate of 1.92 mL/day for 28-31 days. Infusions were initiated approximately 5 days
after surgical implantation of the delivery systems (pumps and intrathecal catheters), and investigators were
blinded to doses administered. An additional group of sheep (N=3) received hydromorphone (open label) at a
dose of 12 mg/day. All animals were examined daily during drug infusion for changes in behavior and
neurologic function. Cerebrospinal fluid was analyzed for protein, cytology, and hydromorphone concentration
in samples collected prior to and at the end of drug infusion. The spinal cord with the catheter in situ was
removed en bloc and fixed in formalin for microscopic analysis. RESULTS: All sheep receiving intrathecal
hydromorphone exhibited gaiting deficits and biting behavior over the caudal lumbar area above the infusion
site. Animals treated with 12 mg/day were sedate and lethargic, and exhibited repeated biting behavior over
the caudal lumbar area during the study. No lesions were noted in any animal upon gross
evaluation of the spinal cord. Microscopic changes were comparable between
hydromorphone- and saline-treated animals with one exception. Mild inflammation 5
cm cranial to the catheter tip was present in two of three sheep receiving 12 mg/day
and in one of three sheep receiving 1.5 mg/day. Mild chronic inflammation
hydromorphone in the vicinity of the catheter was also presented in saline-treated
animals. CONCLUSIONS: Hydromorphone was not associated with inflammatory mass
formation in the sheep model. Further studies are necessary to determine whether
hydromorphone is a safer alternative to morphine for continuous intrathecal infusion
for the treatment of chronic pain. Copyright American Academy of Pain Medicine

207. Arachnoiditis
 A permanently painful condition that may
include loss of bowel or bladder control,
systemic effects, and motor dysfunction
 More common after spine trauma, spine
surgery, and contrasts.
 Is rare in the US and is seen only on a
small fraction of MRIs

208. MRI of Arachnoiditis:
Clumping of nerve roots
at red dot. Compare with
the free nerve roots below.
Open spine surgery is
thought to be the number
one cause of new
cases of arachnoiditis
today
It is possible the tears of
the dura seen in up to 7%
of open surgeries cause
this inflammation

209. Arachnoiditis Stage 1: Arachnoid Layer
and Spinal Nerves become Inflamed

210. Operative Photograph: First Stage of Adhesive
Arachnoiditis. Nerve roots markedly swollen.

211. Stage 2 Arachnoiditis: Scarring and adhesions
begin to bind the arachnoid and start to
encapsulate spinal nerves

212. Stage 3 Arachnoiditis: Calcification and
hardened scar completely encapsulate nerves

213. Operative Photograph: Final stage of adhesive
arachnoiditis. Appears to be an empty cavity,
nerves totally encased in dense scar tissue

214. Increasing Residual Volumes
and Decreasing Pain Control
 Internal filter occluded (eg. Meperidine at
100mg/cc or MS at 50-100mg/cc)
 Battery Failure (Programmable Pumps)
 Internal programmable pump malfunction
 Catheter occlusion (kinking)
 ?granuloma
Perform catheter study (Indium or contrast), then rotor study,
then if crystallization of drug suspected, warm saline flush of
fill chamber. For battery failure, pump replacement is necessary.

215. Meperidine Crystals under Microscope

216. Expected Residual Volume
with Increasing Pain
 Catheter disconnect or migration
 Tolerance to the drug
 New or worsening disease (eg.
metastasis)
 With low residual volumes, infusion rate
becomes non-linear and slows.
Increase drug delivery, add an adjunctive drug, change drug,
earlier refill dates, consider catheter studies and disease
workup if the above fails.

217. Metastatic vertebral
breast cancer
Osteoporotic compression
fracture

218. Inability to Access Pump
 Inexperience of person performing refill
 Pump inversion
 Pump rotation in skin fold (obesity)
 Seroma, hematoma, or abscess in pocket
Fluoroscopy of pump to confirm location, possible
site revision if necessary. Manual flip of pump is possible
in some patients.

219. Massive
Weight
Loss
(Pump Is
Displaced
Significantly)

220. Massive Weight Gain

221. Intrathecal Pump
May Migrate
Inferiorly
And Rotate
Into Skin Folds
Making Access
Difficult
and May
Lead to
Ulceration
Over Pump

222. Lower than Expected
Residual Volume
 Pump overfill on last refill
 Partial refill: needle pulled out before refill
complete
 Malprogrammed pump
 Primary pump malfunction
 Septum leakage
 Surreptitious patient access of pump (Anesthesiology. 2004
Sep;101(3):807 ), J Anal Toxicol. 1999 Mar-Apr;23(2):130-3.
Close monitoring of refill procedure, double check programming
with a second individual, consideration of a fluoroscopic fill with
contrast to observe septum leakage

223. Inability to Fill Reservoir
Initially or During Refill Period
 Reservoir valve dysfunction or activation
 Technical problem with needle
placement in septum
 Air injected into reservoir
 Lack of removal of prior residual fluid or
attempted overfill
Purge reservoir procedure during implant (pump may be too
cold; removal of all
reservoir contents for subsequent refills. Do NOT attempt
to force fluid into the pump-this will damage the valve

224. Headache, nausea, vomiting
 If hygroma or edema along catheter is visible,
consider CSF leak due to catheter migration or
pericatheter leakage from dura (positional
headache)
 If there is fever and rigid neck, suspect
meningitis
 If none of the above, check pump
programming and pump drug being used
For suspected meningitis, tap CSF through catheter, hospitalize and
place on prophylactic antibiotics. For suspected CSF leakage,
perform catheter study or indium study.

225. Meningitis

226. IV. Medication Effects
 Tolerance
 Loss of libido
 Peripheral edema
 Rash/hives
 Nausea/vomiting
 Sedation
 Weight gain
 Drug precipitation
 Urinary retention
 Constipation
 Diaphoresis
 GRANULOMA
10-15% of Patients
with Intrathecal
Infusion Systems for
Pain have either
intolerable side effects
from the medications
or inadequate pain
relief.
Anderson et al Pain Med Vol2 #4
2001

227. Tolerance is the
Norm
 Mean MS dosing increased from 1.2mg to
5.1mg after 24 months J Pain Symptom Manage.
2001 Oct;22(4):862-71. Long-term intrathecal infusion of
drug combinations for chronic back and leg pain.
 Mean MS dosing increased from 1.1 mg to
3.1mg after 6 months Surg Neurol. 2001
Feb;55(2):79-86; discussion 86-8. Continuous intrathecal
morphine treatment for chronic pain of nonmalignant
etiology: long-term benefits and efficacy. Kumar K, Kelly
M, Pirlot T.

228. Tolerance
 The average increase in the amount of
narcotic used from month 1 to month
12 is a factor of 2.5 times.
 Adding adjunctive meds may lessen this
 Appears to be mediated by the NMDA
receptor activation by narcotics
 No evidence drug holiday or opiate
rotation makes any difference
 May consider oral magnesium and
NMDA antagonists, CCK agents,
microdose naltrexone orally

229. Hypogonadism in Males with
Intrathecal Opiate Infusion
0
10
20
30
40
50
60
Testosterone Free Androgen
Index
LH
Control
IT Opiates
Normal Ranges: Testosterone 9=26 nm/l, FAI 30-80, LH2-9U/L
The Journal of Clinical Endocrinology & Metabolism Vol. 85, No. 6 2215-2222

230. Hypogonadism in
Postmenopausal Females with
IT Opiate Infusions
0
5
10
15
20
25
30
35
40
LH FSH
Controls
IT Opiates
The Journal of Clinical Endocrinology & Metabolism Vol. 85, No. 6 2215-2222
Normal Values:LH>13 U/L, FSH>38 U/L

231. Percent of Patients with
Significant Reduction or
Absence of Libido
0
10
20
30
40
50
60
70
80
90
100
Males Females
Pain Patient Controls
IT Infusion
The Journal of Clinical Endocrinology & Metabolism Vol. 85, No. 6 2215-2222

232. Diagnostic Recommendations
for Sexually Active Patients
 Baseline FSH, LH in women and baseline
testosterone, LH in men prior to implant
 One month post implant testing
 Endocrinology referral when appropriate
(especially for women)

233. Treatment Options:
 Androderm for males if the PSA is normal
and there is no history of prostate CA.
 Injectable testosterone if above is not
possible
 Viagra or equivalent for both males and
females if not contraindicated by other
medical conditions
 Consider urology consultation

235. Peripheral Edema
 Much higher incidence in patients with pre-
existing arterial or venous vascular disease,
DVT history, and is made much worse in
patients who already have peripheral edema
 6-20% incidence with IT opiate infusions
 8/37 patients receiving hydromorphone IT
exhibited peripheral edema (Anderson et al)
 Only 16% improve through opiate rotation
 Mechanism: release of vasopressin from
posterior pituitary (induced by IT opiates)

236. Treatment of Peripheral Edema
Induced by Intrathecal Opiates
 Diuretics
 Elastic support stockings
 Compression pumps
 Opiate rotation(unproven)
 Discontinuation of opiates (In a small
study of 23 patients, the reduction of
intrathecal opiates improved peripheral
edema)
Leg edema from intrathecal opiate infusions. Eur J Pain. 2000;4(4):361-5.

237. Rash/hives
 Rare with intrathecal infusion since the
non-immunological production of hives
is due to mast cell degranulation due to
a direct morphine effect. However, in
the CSF there are not many mast cells.
 Rashes may be due to pruritic patient
response.
 Rash may be due to herpes reactivation
 Treatment is switching to an alternative
opiate.

238. Nausea/vomiting from Intrathecal
Opiates
 Direct effect of hydrophilic opiates on the
vomiting center and CTZ.
 Usually is self limiting
50% have nausea/vomiting
immediately after
implantation: this drops to
25% after 1 year
 Incorporate conservative
treatments-cyclizine may
 be more effective than some
other therapies

240. Sedation
 Too high a drug dose
 Combination effect with other sedatives
 May be due to pump mis-programming
 Treatment: Switch to a more lipophilic drug (fentanyl,
sufentanil) or reduce rate of infusion; add Provigil
200mg PO BID-TID, dexadrin, Vivactyl

241. Weight Gain
 Through reduction in
GH, muscle is loss and
fat is added.
 Lack of activity due to chronic
pain
 Peripheral edema
 Failure to adjust eating
downward in spite of
decreased TSH and GH

242. Treatment of Weight Gain: Exercise

243. Intrathecal
Opiates
May Lead
To
Bladder
Distension

244. Urinary Retention
 Present in approx 42% initially but
gradually declines
 May be detrusor muscle direct effect
 Treatment: carbichol, flomax.
 Catheterize if severe

245. Constipation
 Up to 50% with IT MS infusions
 1st step: increase water consumption
 2nd step: OTC laxatives
 3rd step: Miralax
 4th step: Pyridostigmine

246. Paice JA, Penn RD,
Shott S: Intraspinal
morphine for chronic
pain: a retrospective,
multicenter study. J
Pain Symptom Manage
1996;11:71-80
Winkelmuller M,
Winkelmuller, W:
Long-term effects of
continuous intrathecal
opioid treatment in
chronic pain of
nonmalignant
etiology. J Neurosurg
1996;65:458-467
 Winkelmull
er
 Paice
 4.9
 5.4
 11.7
 7.2
 13.3
 25.2%
 8.5
 Diaphoresis
 4.9
 Reduced libido
 Weight gain
 6.1
 Edema
 14.6
 Pruritus
 42.7
 Urinary retention
 50
 Constipation
 36.6%N,
24.4V
 Nausea and vomiting

247. Side Effects of Systemic vs.
Intrathecal Opioids
Adverse Events
Short-Term Long-Term
Side Effect Systemic Intrathecal Systemic Intrathecal
Constipation ++ (+) + -
Nausea ++ (+) (+) -
Vomiting + (+) (+) -
Pruritus (+) (+) - -
Urinary retention (+) (+) (+) -
Erectile dysfunction (+) (+) (+) (+)
Sedation + - - -
Respiratory - - - -
depression
Endocrinological - - + +
changes
++ = Side effect occurs in most patients + = Side effect occurs in some patients
(+) = Side effect occurs, but tolerance develops - = Side effect does not occur
Short- and Long-term Side Effects: Systemic vs. Intrathecal Opioids
Naumann, et al. Neuromodulation. 1999;2(2):92-107. (From Mueller-Schwefe
G.’s presentation at 4th International Congress of the International
Neuromodulation Society; September 20 1988; Lucerne, Switzerland)

248. Reduction in 15 Toxicities
*Statist.
Signific.
(P<0.05)
Individual
Toxicity
Reduction in Mean
Severity
CMM
IDDS
-0.3 -0.2 -0.1 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8
Reduced libido
Urticaria
Pruritus
Weight loss
Vomiting
Nausea
Dehydration
Constipation
Anorexia
Personality
Memory loss
Reduced level of consciousness
Confusion
Fatigue
*
*
Impotence
Journal of Clinical Oncology, Vol 20, No 19, October 1, 2002: 4040-4049.

249.  Oral Robinul
 Diaphoresis
 Surgical decompression/Catheter
revision, change to hydromorphone
 Inflammatory mass
 Mg, NMDA ant orally
 Tolerance
 Replace catheter/filter drug
 Precipitation
 Reduce morphine/add bupivacaine,
Androderm, Viagra
 Loss of libido
 Change medication
 Weight gain
 Change medication, diuretic
 Leg Edema
 Diphenhydramine, Zyrtec
 Pruritus
 Catheterization
 Carbachol 2mg/Naloxone 0.2mg
 Urinary retention
 Laxative/Stool softener
 Constipation
 Anti-emetic, switch narcotic
 Nausea and vomiting

250. In spite of pump system functioning
properly, patient is convinced the
pump is not doing anything...
 Turn off pump or withdraw all the meds
from the reservoir (unless baclofen is
the primary drug)
 Some have unrealistic expectations-
need help in redefining these
 Some patients are just nuts.
 If you don’t like the patient,
then don’t implant. Try to find out
if they are nuts beforehand.

251. Contraindications To IT Pump
 Infection
 Subcutaneous fat less than 2.5 cm
 Inadequate body size
 Allergy to morphine
 Coagulopathy
 Pregnancy
 Inability to keep follow-up appointments
 Patient is Nuts
 Substance Abuse

252. Selected
OUTCOME STUDIES

253. Pain Med. 2004 Mar;5(1):6-13. Intrathecal drug delivery for treatment of chronic low
back pain: report from the National Outcomes Registry for Low Back Pain. Deer T,
Chapple I, Classen A, Javery K, Stoker V, Tonder L, Burchiel K. Center for Pain Relief,
Charleston, West Virginia 25301, USA. doctdeer@aol.com OBJECTIVE: To obtain data on
patient demographics, clinical practices, and long-term outcomes for patients with
chronic low back pain treated with implantable drug-delivery systems. DESIGN: The
National Outcomes Registry for Low Back Pain collected data at baseline, trialing,
implant (or decision not to implant), and at 6- and 12-month follow-ups. Data were
collected at all time points, regardless of implant status. OUTCOME MEASURES: Numeric
pain ratings and Oswestry Low Back Pain Disability scores from implanted patients were
compared among baseline and 6- and 12-month follow-ups. Patients were also asked to
rate their quality of life and satisfaction with the therapy. RESULTS: Thirty-six physicians
enrolled 166 patients to be trialed for drug-delivery systems. The trialing success rate
was 93% (154 patients). In all, 136 patients (82%) were implanted. In the implant
group, numeric pain ratings dropped by more than 47% for back pain and more than
31% for leg pain at the 12-month follow-up. More than 65% of implanted patients
reduced their Oswestry scores by at least one level at their 12-month follow-ups
compared with baseline. At 12-month follow-ups, 80% of implanted patients were
satisfied with their therapy and 87% said they would undergo the procedure again.
CONCLUSIONS: Current clinical practices related to trialing of drug-delivery systems
resulted in the majority of patients successfully trialed. At 12-month follow-ups,
implanted patients experienced reductions in numeric back and leg pain ratings,
improved Oswestry scores, and high satisfaction with the therapy. Copyright American
Academy of Pain Medicine

254. J Neurosurg. 2002 Oct;97(4):803-10. Treatment of chronic pain by using intrathecal
drug therapy compared with conventional pain therapies: a cost-effectiveness analysis.
Kumar K, Hunter G, Demeria DD. Department of Surgery, Section of Neurosurgery, Regina General
Hospital, University of Saskatchewan, Regina, Saskatchewan, Canada. kkumar@reginahealth.sk.ca
OBJECT: The object of this study was to compare the cost-effectiveness of intrathecal drug therapy
(IDT) with that of conventional pain therapy (CPT) in patients suffering from chronic low back pain
caused by failed back syndrome. In this study, the authors tabulated actual costs, in Canadian
dollars, in a consecutive series of patients undergoing IDT within the Canadian health care system
and have compared them with costs in a control group in the same environment. The influence of
these treatments on the quality of life (QOL) was also analyzed. METHODS: The authors report
on a series of 67 patients suffering from failed back syndrome, 23 of whom underwent
implantation of a programmable drug delivery pump and 44 of whom acted as controls.
Patients were followed for a 5-year period during which the investigators tabulated the
actual costs incurred for diagnostic imaging, professional fees, implantation costs
including hardware, nursing visits for maintenance of the pumps, alternative therapies,
and hospitalization costs for breakthrough pain. From this data, cumulative costs for
each group were calculated for a 5-year period. Patient responses on the Oswestry Pain
Questionnaire were analyzed to assess the impact of treatment on QOL. The actual
cumulative costs for IDT during a 5-year period were $29,410, as opposed to $38,000
for CPT. High initial costs of equipment required for IDT were recovered by 28 months.
After this time point, managing patients with CPT became the more expensive treatment
option for the remainder of the follow-up period. The Oswestry Disability Index showed
a 27% improvement for patients in the IDT group, compared with a 12% improvement
in the control group. CONCLUSIONS: In patients who respond to this treatment, IDT is
cost effective in the long term despite high initial costs of implantable devices.

255. Surg Neurol. 1998 Jan;49(1):92-8; discussion 98-9. Intrathecal morphine pump as a
treatment option in chronic pain of nonmalignant origin. Angel IF, Gould HJ Jr, Carey ME.
Department of Neurosurgery, Louisiana State University Medical Center, New Orleans
70112, USA. BACKGROUND: Implantable pumps for the delivery of intrathecal morphine
have become a common option for administering opiate medication for the management
of pain in patients with terminal cancer. Options for treating chronic pain of non-
malignant origin are more controversial. This study describes responses to intrathecal
morphine administration for managing chronic pain in patients without an underlying
malignancy. METHODS: Eleven patients between the ages of 29 and 81 years, nine with
failed back syndrome (FBS) and two with neuropathic pain (NP) from other causes, were
chosen from 15 consecutive individuals referred to neurosurgery clinic. The presenting
levels of pain and a functional-economic outcome level were determined for each
patient. Patients were admitted to the hospital for therapeutic trials and were assessed
for the appropriateness of their analgesic response and for adverse responses to the
medication. A morphine pump was implanted in five males and six females who were
followed for up to 3 years. RESULTS: A good to excellent analgesic response was seen in
8 (73%) patients (6 FBS; 2 NP). In the remaining three patients (27%), the analgesic
response was judged poor (3 FBS). In patients with FBS, the total effective response
was 67%. Two patients experienced bladder dysfunction requiring pump removal. Other
adverse effects of pump placement were rare. CONCLUSIONS: The morphine pump was
found to be a viable alternative in the management of failed back syndrome. Its use in
long-term therapy, however, is not without limitations and should be a last choice
option.

256. J Neurosci Nurs. 1998 Aug;30(4):233-9, 243-4. Managing chronic
nonmalignant pain with continuous intrathecal morphine. Valentino L, Pillay KV,
Walker J. Methodist Hospitals, Merrillville, Indiana 46410, USA. One alternative
to traditional treatment modalities for chronic pain is continuous intrathecal
administration of morphine via an implanted pump. However, relatively little is
known about the benefits and long-term complications of this therapy for
chronic nonmalignant pain. The purpose of this study was to describe patient
responses to continuous intrathecal morphine over the course of one year with
respect to morphine dosage used, complications and subjective assessments of
pain. Data were obtained from twelve patients who completed one year of
therapy. After one year, a 42% reduction in pain as measured by the McGill
pain questionnaire had occurred (p < .01). A similar 41% reduction in pain was
also present based on the Verbal Descriptor Scale (p < .01). A 35% reduction
in the perceived hardship of pain was present (p < .01) accompanied by
anecdotal comments that an improvement in the ability to manage activities of
daily living had occurred. One patient was able to return to work. A statistically
nonsignificant increase in the mean daily dosage of morphine occurred and
few long-term adverse effects were present. Complications of implantation
occurred in 33.3% of the patients and were successfully managed without
discontinuing therapy. In selected patients with chronic pain, intrathecal
administration of morphine via an implanted pump can reduce pain with
minimal long-term adverse effects or complications

257. Clin Ther. 1997 Jan-Feb;19(1):96-112; discussion 84-5. Cost-effectiveness of long-term
intrathecal morphine therapy for pain associated with failed back surgery syndrome. de
Lissovoy G, Brown RE, Halpern M, Hassenbusch SJ, Ross E. A decision analytic study
was conducted using computer simulation to project the outcomes in a simulated cohort
of patients whose treatment for back surgery had failed. The objective of this study was
to estimate the direct cost of intrathecal morphine therapy (IMT) delivered via an
implantable pump relative to alternative therapy (medical management) over a 60-
month course of treatment. IMT administered by way of an implantable pump can provide effective pain
relief for selected patients whose less invasive treatment modalities have failed. Previous research suggested that
a pump implant is less costly than alternative methods providing comparable analgesia for treatment exceeding
12 to 18 months. However, those analyses did not include the cost of complications or pump replacement.
Scenarios representing the course of IMT, devised by a panel of experts, were represented as treatment pathways
in a Monte Carlo simulation. Adverse event rates were drawn from published data supplemented by expert
judgment. Direct costs were based on a health insurer paid claims perspective (direct costs) discounted at a 5%
annual rate. The cost-effectiveness of IMT was calculated based on a report of 65% to
81% "good to excellent" pain relief relative to alternative (medical) management. With
both adverse event probabilities and costs set at most likely (base case) values, the
expected total cost of IMT over 60 months was $82,893 (an average of $1382 per
month). In a sensitivity analysis, the best case (low adverse event rate, low cost)
estimate was $53,468 ($891/mo), whereas the worst case (high adverse event rate,
high cost) estimate was $125,102 ($2085/mo). Cost-effectiveness estimates ranged
from $7212 (best case) to $12,276 (worst case) per year of pain relief. Results from a
computer simulation designed to collect the costs not included in previous empiric
research indicate that IMT appears to be cost-effective when compared with alternative
(medical) management for selected patients when the duration of therapy exceeds 12 to
22 months.

258. Rehabil Nurs. 2003 Sep-Oct;28(5):159-63. A self-report of quality of life of
patients receiving intrathecal baclofen therapy. Staal C, Arends A, Ho S. Center for Limb
Differences, Mary Free Bed Hospital and Rehabilitation Center, 235 Wealthy Street, Grand Rapids, MI 49503, USA.
cstaal@mfbrc.com The purpose of this study was to explore through a department quality
improvement tool a possible relation between quality of life (QOL), complication rates,
and length of intrathecal baclofen (IB) treatment as reported by patients receiving IB
therapy in a community-based rehabilitation center outpatient clinic. A second objective
was to examine complication rates among the clinic's patients. No conclusions could be drawn
as to the relation between QOL, various reported complications, and length of treatment. A rank order frequency
of areas reported by respondents to have the greatest impact on their QOL could be extrapolated from the data
collected. In addition, complication rates among the patients who responded to the survey could be reported.
Surveys from 49 patients about their experiences with IB therapy were analyzed.
Respondents included 30 adult and 19 pediatric patients. Thirty-six patients (73%) had
used the IB pump for 1 year or more. The survey included questions about QOL,
complications, and length of IB treatment. Forty-three respondents (88%) stated
they felt that their QOL had improved with IB therapy. Four patients (8%)
responded that they were not sure that it had, and only 2 patients (4%) said
that IB had not improved their QOL. The most frequently reported positive effects
on QOL were reported in the following areas: spasticity control without the sedative
effect of oral medication; ease of care for caregivers; easier positioning; less
pain/increased comfort; and improved patient transfers. High ratings of improvement in the
patients' QOL were reported despite a reported overall complication rate of 39%. The most common
complications cited were infection and catheter breakage or disconnect. The overall infection rate for respondents
was 10% (5 patients of the 49 surveyed reported infection). The rate of catheter breakage or disconnect was also
10%. Despite the complications reported, 46 patients stated they would recommend baclofen treatment to
others. Three patients did not respond to the question. None of the patients said they would not recommend
baclofen to others.

259. Impact of Intrathecal Morphine
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Great Moderate Slight
Effect on ADL
Patient Satisfaction
Paice JA, Penn RD, Shott S. Intraspinal Morphine for Chronic Pain: A Retrospective, Multicenter Study, JPSM,
Feb. 1996; 11(2):71-80.

260. Clinical Experience with
Intrathecal Therapy
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Patients Receiving
Good to Excellent
Pain Relief
Paice et al.,
1996 95%
97% Gilmer-Hill,
1999
88% Krames,
Gershow,
1985
84% Penn,
Paice, 1987
Follett et al., Z
1992 77%
64% Onofrio,
Yaksh, 1990
76% Devulder,
1996
79%
Shetter,
1986

261. Surg Neurol. 1999 Jan;51(1):6-11. Intrathecal morphine delivered via
subcutaneous pump for intractable pain in pancreatic cancer. Gilmer-Hill HS, Boggan
JE, Smith KA, Frey CF, Wagner FC Jr, Hein LJ. Department of Neurological Surgery, UC Davis Medical Center,
Sacramento, California 95817, USA. BACKGROUND: Pain secondary to unresectable pancreatic cancer is
frequently severe and extremely difficult to control with traditional methods of analgesia. This retrospective study
reports the analgesic effects of intrathecal morphine sulfate by implanted infusion pumps in nine patients with
unresectable adenocarcinoma of the pancreas. METHODS: Nine patients were implanted over a 2-
year period. Preoperative morphine i.v. equivalents were a mean of 81.51 mg/day, with
a range of 20-140 mg/day. Patients were hospitalized for a trial dose of 1-2 mg of
intrathecal Duramorph, 1 mg/ml, via lumbar puncture to assess whether adequate pain
relief could be achieved and whether there would be drug-related side effects.
RESULTS: All patients who received a trial dose experienced excellent pain relief, and
subsequently underwent implantation of a lumbar subarachnoid catheter and infusion
pump during the same hospitalization. The mean number of days from diagnosis to
pump implant was 119, with a range of 3-587 days. The mean maximum daily dose was
21.28 mg, with a range of 3-73.10 mg. No patient experienced respiratory depression or
excess sedation which prevented achievement of pain control. Minor supplemental
narcotic use was documented in three of the nine patients. Assessment of pain control
was made by the level of activity and the analog pain scale, with 0 being no pain and 10
being the worst pain imaginable. All of the patients experienced good to excellent relief
of pain. The mean duration of intrathecal morphine sulfate use until death was 137.3
days, with a range of 52-354 days. CONCLUSIONS: This series of nine patients indicates
that long-term administration of intrathecal morphine via implanted infusion pump in
patients with pancreatic cancer is both efficacious and safe. All patients and their
families reported an improved quality of life with an increased level of activity.

262. Curr Pain Headache Rep. 2005 Aug;9(4):243-8. Pain management, including intrathecal
pumps. Smith TJ, Swainey C, Coyne PJ. Division of Hematology/Oncology and Palliative
Care, Massey Cancer Center of Virginia Commonwealth University, MCV Box 980230,
Richmond, VA 23298-0230, USA. tsmith@hsc.vcu.edu. Even when managed
according to guidelines, approximately 14% of cancer patients have unrelieved
pain or unacceptable side effects, and there is good evidence that patients still
are not receiving optimal therapy. Implantable drug delivery systems (IDDS)
administer small amounts of drugs directly to the spinal cord and reduce
systemic narcotic exposure by a factor of 300 to one. In a large randomized
trial of 202 patients with pain scores of 7.5 or higher, despite 200 mg or more
of morphine or equivalent narcotics, IDDS gave better clinical success than
comprehensive medical management (84.5% vs 70.8%, P=0.05). Pain scores
were reduced by 52% versus 39%, drug toxicity scores were reduced by 50%
versus 17%, and IDDS patients lived longer. Even the most refractory pain
patients--those failed by a month of comprehensive medical management by
experts--when subsequently provided with IDDS, had a 27% reduction in pain
scores and a 50% reduction in drug side effects. Given multiple
positive small cohort studies and a positive high-power
randomized trial, IDDS should be considered as the best
treatment for this population.

263. Palliat Med. 2004 Sep;18(6):507-15. Evolving spinal analgesia practice in
palliative care. Baker L, Lee M, Regnard C, Crack L, Callin S; Tyneside Spinals
Group. St. Oswald's Hospice, Newcastle upon Tyne, UK.
lisabaker@doctors.org.uk Intraspinal analgesia can be helpful in some patients
with intractable pain. Over 15 years palliative care professionals evolved their
spinals policy through a repeated series of evaluations, discussions and
literature reviews. One hundred intraspinal lines were then reviewed. Notable
changes in policy were the switch from epidurals to intrathecals, and the
insertion of lines during working hours rather than as emergencies. Our
efficacy, and frequency of adverse effects, is equal or better to published
studies. Key issues in reducing adverse effects were the improved care of the
spinal line exit site, a change from bolus administration to continuous
infusions, and modifying line insertion techniques. Current policy is to use
continuous infusions of diamorphine and bupivacaine in a 1:5 ratio through
externalized intrathecal lines. The lines are effective in approximately
two thirds of patients and can be kept in place for up to 18 months.
The policy continues to be updated and common documentation is now in
place.
External Intrathecal Lines for Long Term Use: Argument for Functional Intrathecal Trials

264. High Dose Oral Opiate Side Effect
Reason Number 228
to Implant an
Intrathecal Pump