Intrathecal Infusion Pumps for Pain:
Supporting References
Pain Med. 2006 Jan-Feb;7(1):10-5.
Intrathecal hydromorphone for intractable nonmalignant pain: a retrospective study.
Du Pen S, Du Pen A, Hillyer J. Overlake Pain Medicine Clinic, Overlake Medical Center, Bellevue, Washington 98004, USA. stuart.dupen@overlakehospital.org
BACKGROUND: Hydromorphone is often administered intrathecally for the treatment of cancer and nonmalignant chronic intractable pain. It is frequently
utilizedin combination with other analgesics in a multidrug intrathecal infusion; however, very little data are available documenting efficacy or safety of
intrathecal hydromorphone as a solo analgesic. OBJECTIVE: This study was conducted to examine pain and side effects in patients receiving intrathecal
hydromorphone. DESIGN: A retrospective review was conducted of all patients receiving intrathecal hydromorphone monotherapy in two large pain specialty
practices in the Pacific Northwest. All data collected within 30 days of the patient's 3-month, 6-month, and 12-month anniversary of implant were analyzed.
PATIENTS: Twenty-four patients with noncancer-related chronic pain were included in the study. Thirteen patients had eligible pain data at 1 month, 10 patients
had pain data at 3 months and seven patients had pain data available at 12 months after initiation of intrathecal hydromorphone. RESULTS: Average pain
scores decreased significantly (P = 0.03). Side-effect and pain-interference scores remained essentially unchanged in this small sample of patients
J Palliat Med. 2005 Aug;8(4):736-42.
Implantable drug delivery systems (IDDS) after failure of comprehensive medical management (CMM) can palliate symptoms in the most refractory cancer pain
patients.
Smith TJ, Coyne PJ. Thomas Palliative Care Unit, Division of Hematology/Oncology and Palliative Care, Virginia Commonwealth University, MCV Box 980230,
Richmond, VA 23298-0230, USA. tsmith@hsc.vcu.edu
BACKGROUND: A randomized clinical trial of implantable drug delivery system (IDDS) plus comprehensive medical management (CMM) versus CMM alone in 200
patients with refractory cancer pain showed better clinical success with IDDS. The objective of this study was to evaluate whether IDDS could help the most
refractory patients failed by expert CMM. PATIENTS AND METHODS: This was a planned longitudinal prospective analysis of 30 of 99 (30%) patients for whom
CMM failed who crossed over to IDDS by 6 months, as part of the randomized clinical trial. Patients had a pain visual analogue scale (VAS) score of 5 or
more despite CMM with 320 mg or morphine-equivalent opioids and adjunct drugs for 1 month. The intervention was an implantable intrathecal programmable
pump with opioids and local anesthetics. Clinical success was measured as a 20% change in pain VAS score and NCI CTEP drug toxicity scales. RESULTS:
Clinical success was achieved with pain scores and drug toxicity scores significantly reduced by 27% (p = 0.011) and 51% (p < 0.0001). Median survival was 103
days after IDDS implant, similar to IDDS patients who received implantation as part of the initial randomization. CONCLUSIONS: CMM patients who crossed over
to IDDS for the most refractory pain had significant reductions in pain and drug toxicity. The survival time of 3 months may be long enough for the IDDS implant
to be cost effective. In this prospective longitudinal study, patients with refractory cancer pain despite comprehensive medical management derived benefit
from IDDS.
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 Universi ty, 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 largerandomized 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 clinicalsuccess 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
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
Pain. 2003 Mar;102(1-2):163-6. Management of chronic intractable angina - spinal opioids offer an alternative therapy. Cherry DA, Gourlay GK, Eldredge
KA. Pain Management Unit, Flinders Medical Centre, Bedford Park, SA 5042, Australia. david.cherry@flinders.edu.au The successful treatment of chronic
intractable angina by spinally administered opioids via an Algomed drug delivery device (hereinafter called the pump) is reported in seven patients. All
patients had at least two prior cardiac surgeries and the duration of minimally controlled chronic intractable angina varied from 5 to 19 years prior to
spinally administered opioids. The duration of effective spinally administered analgesia to either the epidural (two cases) or intrathecal (five cases) spaces
varied from 2 to 7 years. The opioid used was either morphine or fentanyl and the dose increase (either mg/year or microg/year, respectively) varied from
1.2 to 16. We suggest that bolus spinal morphine or fentanyl administered via the pump is a viable alternative for the effective control of angina when more
established therapies have been found to provide insufficient pain relief.
Acta Anaesthesiol Scand. 2002 Jan;46(1):114-7. Successful treatment of restless legs syndrome with an implanted pump for intrathecal drug delivery.
Jakobsson B, Ruuth K. Pain Clinic, Department of Anaesthesia and Intensive Care, Pitea Hospital, Sweden. bengt.jakobsson@nll.se Two patients with
incapacitating symptoms from restless legs syndrome, not adequately responding to conventional treatment with dopaminergic drugs, were implanted with a
pump device (Isomed) for intrathecal delivery of morphine and bupivacaine. The treatment resulted in total resolution of all symptoms with few side effects.
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
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.
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. MEDTAP International, Inc., Bethesda, Maryland, USA. 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.
Ned Tijdschr Geneeskd. 1996 Jul 6;140(27):1410-2. [Intrathecal administration of morphine and bupivacaine in the treatment of severe pain in chronic
pancreatitis] [Article in Dutch] Verheijen R, Slappendel R, Jansen JB, Crul BJ, van Dongen RT. Pijnteam/Instituut voor Anesthesiologie, Academisch
Ziekenhuis, Nijmegen. A 25-year-old male with idiopathic chronic pancreatitis suffered from severe pain not reacting to medical therapy. Intractable pain
persisted after the following procedures: subtotal resection of the pancreas, interpleural administration of bupivacaine, epidural administration of
bupivacaine, and thoracoscopic sympathectomy. Eventually, adequate pain relief was achieved with intrathecal administration of morphine and bupivacaine.
An infusion pump, externally controlled by radiotelemetry, was implanted subcutaneously for intrathecal drug administration. With this pump the patient
was fully ambulant. Intrathecal administration of morphine and bupivacaine through an implanted pump is a possible new technique for pain management
in chronic pancreatitis.
South Med J. 1996 Mar;89(3):295-300. Intrathecal infusion systems for treatment of chronic low back and leg pain of noncancer origin. Tutak U, Doleys
DM. Department of Anesthesiology and Pain Management Services, HealthSouth Medical Center, Birmingham, Ala, USA. In this study, 26 patients
(average age, 44.3 years) with chronic noncancer pain averaging 115 months' duration had implantation of an infusion pump with intrathecal catheter
placement. In general, preservative-free morphine sulfate was used. Average follow-up was 23 months. Measurements of pain reduction, activity
improvement, oral medication use, and overall satisfaction by patient, spouse, and clinic staff were obtained. Of the 26 patients, 20 noted a good or excellent
outcome. Average daily dosage of intrathecal morphine increased over time by approximately sevenfold. Subjective pain levels decreased an average of
59%, and daily functioning increased 50%. No postoperative complications were noted, but 11 patients required additional surgery (9 for catheter
complications). These data support chronic spinal opiate therapy as an option for safe and long-term management of noncancer pain.
Can J Neurol Sci. 1995 May;22(2):153-9. Comment in: Can J Neurol Sci. 1996 May;23(2):156-7. Long term treatment of intractable reflex sympathetic
dystrophy with intrathecal morphine. Becker WJ, Ablett DP, Harris CJ, Dold ON. Department of Clinical Neurosciences, University of Calgary, Alberta,
Canada. BACKGROUND: Some patients with reflex sympathetic dystrophy (RD) develop intractable symptoms unresponsive to conventional therapy.
Recently, intrathecal morphine therapy has been used with some success in such patients. METHODS: The clinical course of two patients with intractable
reflex sympathetic dystrophy (RSD) is described. Both patients developed intractable leg pain, swelling and autonomic changes after a leg injury. Numerous
medical treatments and surgical sympathectomies failed to provide long term relief. RESULTS: Relatively satisfactory symptom control was achieved only
with the use of long term intrathecal morphine therapy delivered by subcutaneously implanted infusion pumps. Exacerbations of the RSD continued to
occur, at times in association with further leg trauma, but these could be controlled by a temporary escalation of the intrathecal morphine dose.
Complications of morphine therapy were relatively minor. A red rash appearing over the pump site was the first sign that a drug catheter break had
occurred, necessitating surgical catheter revision. CONCLUSION: Long term intrathecal morphine therapy is a useful treatment option for patients with
intractable severe RSD who have failed other therapies and remain markedly disabled.
J Neurosurg. 1990 Feb;72(2):200-9. Long-term pain relief produced by intrathecal morphine infusion in 53 patients. Onofrio BM, Yaksh TL. Department of
Neurologic Surgery, Mayo Clinic, Rochester, Minnesota. The present report details the characteristics of the analgesic effects of morphine administered
chronically by infusion pumps implanted in 53 patients suffering from terminal metastatic disease. The median postimplant survival time in these patients
was 4 months. Patients (mean age 58 years) were characterized according to the duration of pain before pump implantation (mean 16 months), prior
consumption of systemic opioids (mean one to six daily analgesic equivalents of morphine), and their response to a trial intrathecal dose of morphine (1 to 2
mg). The median infusion dose at 2 weeks was 3.8 mg/day. The analgesic index, calculated as (quality of pain relief x duration of pain relief in
hours)/morphine dose in mg, that was observed after the trial dose of morphine was determined for each patient. A close correlation was observed between
the acute (2-week) infusion dose necessary to produce pain relief and the analgesic index such that the infusion dose = -8.0 x log (analgesic index) + 17.1.
By 16 weeks, the mean spinal morphine dose for the group had increased by a factor of about 2.5; however, significant variation in the dose incrementation
was documented. The maximum increase was observed in patients with a low analgesic index, and this rapid incrementation was usually correlated with an
unsatisfactory overall outcome. Evidence that long-term infusion continues to yield analgesia was evidenced in six cases where there was an unanticipated
loss of drug infusion and a corresponding increase in parenteral narcotic consumption. These data indicate the long-term efficacy and safety of spinal opioid
infusion in patients with terminal cancer, and emphasize the advantage of assessing the sensitivity of the patient to spinal opioids by a standardized trial
injection prior to pump placement as a prognostic indication of outcome
Supporting References
Pain Med. 2006 Jan-Feb;7(1):10-5.
Intrathecal hydromorphone for intractable nonmalignant pain: a retrospective study.
Du Pen S, Du Pen A, Hillyer J. Overlake Pain Medicine Clinic, Overlake Medical Center, Bellevue, Washington 98004, USA. stuart.dupen@overlakehospital.org
BACKGROUND: Hydromorphone is often administered intrathecally for the treatment of cancer and nonmalignant chronic intractable pain. It is frequently
utilizedin combination with other analgesics in a multidrug intrathecal infusion; however, very little data are available documenting efficacy or safety of
intrathecal hydromorphone as a solo analgesic. OBJECTIVE: This study was conducted to examine pain and side effects in patients receiving intrathecal
hydromorphone. DESIGN: A retrospective review was conducted of all patients receiving intrathecal hydromorphone monotherapy in two large pain specialty
practices in the Pacific Northwest. All data collected within 30 days of the patient's 3-month, 6-month, and 12-month anniversary of implant were analyzed.
PATIENTS: Twenty-four patients with noncancer-related chronic pain were included in the study. Thirteen patients had eligible pain data at 1 month, 10 patients
had pain data at 3 months and seven patients had pain data available at 12 months after initiation of intrathecal hydromorphone. RESULTS: Average pain
scores decreased significantly (P = 0.03). Side-effect and pain-interference scores remained essentially unchanged in this small sample of patients
J Palliat Med. 2005 Aug;8(4):736-42.
Implantable drug delivery systems (IDDS) after failure of comprehensive medical management (CMM) can palliate symptoms in the most refractory cancer pain
patients.
Smith TJ, Coyne PJ. Thomas Palliative Care Unit, Division of Hematology/Oncology and Palliative Care, Virginia Commonwealth University, MCV Box 980230,
Richmond, VA 23298-0230, USA. tsmith@hsc.vcu.edu
BACKGROUND: A randomized clinical trial of implantable drug delivery system (IDDS) plus comprehensive medical management (CMM) versus CMM alone in 200
patients with refractory cancer pain showed better clinical success with IDDS. The objective of this study was to evaluate whether IDDS could help the most
refractory patients failed by expert CMM. PATIENTS AND METHODS: This was a planned longitudinal prospective analysis of 30 of 99 (30%) patients for whom
CMM failed who crossed over to IDDS by 6 months, as part of the randomized clinical trial. Patients had a pain visual analogue scale (VAS) score of 5 or
more despite CMM with 320 mg or morphine-equivalent opioids and adjunct drugs for 1 month. The intervention was an implantable intrathecal programmable
pump with opioids and local anesthetics. Clinical success was measured as a 20% change in pain VAS score and NCI CTEP drug toxicity scales. RESULTS:
Clinical success was achieved with pain scores and drug toxicity scores significantly reduced by 27% (p = 0.011) and 51% (p < 0.0001). Median survival was 103
days after IDDS implant, similar to IDDS patients who received implantation as part of the initial randomization. CONCLUSIONS: CMM patients who crossed over
to IDDS for the most refractory pain had significant reductions in pain and drug toxicity. The survival time of 3 months may be long enough for the IDDS implant
to be cost effective. In this prospective longitudinal study, patients with refractory cancer pain despite comprehensive medical management derived benefit
from IDDS.
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 Universi ty, 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 largerandomized 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 clinicalsuccess 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
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
Pain. 2003 Mar;102(1-2):163-6. Management of chronic intractable angina - spinal opioids offer an alternative therapy. Cherry DA, Gourlay GK, Eldredge
KA. Pain Management Unit, Flinders Medical Centre, Bedford Park, SA 5042, Australia. david.cherry@flinders.edu.au The successful treatment of chronic
intractable angina by spinally administered opioids via an Algomed drug delivery device (hereinafter called the pump) is reported in seven patients. All
patients had at least two prior cardiac surgeries and the duration of minimally controlled chronic intractable angina varied from 5 to 19 years prior to
spinally administered opioids. The duration of effective spinally administered analgesia to either the epidural (two cases) or intrathecal (five cases) spaces
varied from 2 to 7 years. The opioid used was either morphine or fentanyl and the dose increase (either mg/year or microg/year, respectively) varied from
1.2 to 16. We suggest that bolus spinal morphine or fentanyl administered via the pump is a viable alternative for the effective control of angina when more
established therapies have been found to provide insufficient pain relief.
Acta Anaesthesiol Scand. 2002 Jan;46(1):114-7. Successful treatment of restless legs syndrome with an implanted pump for intrathecal drug delivery.
Jakobsson B, Ruuth K. Pain Clinic, Department of Anaesthesia and Intensive Care, Pitea Hospital, Sweden. bengt.jakobsson@nll.se Two patients with
incapacitating symptoms from restless legs syndrome, not adequately responding to conventional treatment with dopaminergic drugs, were implanted with a
pump device (Isomed) for intrathecal delivery of morphine and bupivacaine. The treatment resulted in total resolution of all symptoms with few side effects.
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
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.
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. MEDTAP International, Inc., Bethesda, Maryland, USA. 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.
Ned Tijdschr Geneeskd. 1996 Jul 6;140(27):1410-2. [Intrathecal administration of morphine and bupivacaine in the treatment of severe pain in chronic
pancreatitis] [Article in Dutch] Verheijen R, Slappendel R, Jansen JB, Crul BJ, van Dongen RT. Pijnteam/Instituut voor Anesthesiologie, Academisch
Ziekenhuis, Nijmegen. A 25-year-old male with idiopathic chronic pancreatitis suffered from severe pain not reacting to medical therapy. Intractable pain
persisted after the following procedures: subtotal resection of the pancreas, interpleural administration of bupivacaine, epidural administration of
bupivacaine, and thoracoscopic sympathectomy. Eventually, adequate pain relief was achieved with intrathecal administration of morphine and bupivacaine.
An infusion pump, externally controlled by radiotelemetry, was implanted subcutaneously for intrathecal drug administration. With this pump the patient
was fully ambulant. Intrathecal administration of morphine and bupivacaine through an implanted pump is a possible new technique for pain management
in chronic pancreatitis.
South Med J. 1996 Mar;89(3):295-300. Intrathecal infusion systems for treatment of chronic low back and leg pain of noncancer origin. Tutak U, Doleys
DM. Department of Anesthesiology and Pain Management Services, HealthSouth Medical Center, Birmingham, Ala, USA. In this study, 26 patients
(average age, 44.3 years) with chronic noncancer pain averaging 115 months' duration had implantation of an infusion pump with intrathecal catheter
placement. In general, preservative-free morphine sulfate was used. Average follow-up was 23 months. Measurements of pain reduction, activity
improvement, oral medication use, and overall satisfaction by patient, spouse, and clinic staff were obtained. Of the 26 patients, 20 noted a good or excellent
outcome. Average daily dosage of intrathecal morphine increased over time by approximately sevenfold. Subjective pain levels decreased an average of
59%, and daily functioning increased 50%. No postoperative complications were noted, but 11 patients required additional surgery (9 for catheter
complications). These data support chronic spinal opiate therapy as an option for safe and long-term management of noncancer pain.
Can J Neurol Sci. 1995 May;22(2):153-9. Comment in: Can J Neurol Sci. 1996 May;23(2):156-7. Long term treatment of intractable reflex sympathetic
dystrophy with intrathecal morphine. Becker WJ, Ablett DP, Harris CJ, Dold ON. Department of Clinical Neurosciences, University of Calgary, Alberta,
Canada. BACKGROUND: Some patients with reflex sympathetic dystrophy (RD) develop intractable symptoms unresponsive to conventional therapy.
Recently, intrathecal morphine therapy has been used with some success in such patients. METHODS: The clinical course of two patients with intractable
reflex sympathetic dystrophy (RSD) is described. Both patients developed intractable leg pain, swelling and autonomic changes after a leg injury. Numerous
medical treatments and surgical sympathectomies failed to provide long term relief. RESULTS: Relatively satisfactory symptom control was achieved only
with the use of long term intrathecal morphine therapy delivered by subcutaneously implanted infusion pumps. Exacerbations of the RSD continued to
occur, at times in association with further leg trauma, but these could be controlled by a temporary escalation of the intrathecal morphine dose.
Complications of morphine therapy were relatively minor. A red rash appearing over the pump site was the first sign that a drug catheter break had
occurred, necessitating surgical catheter revision. CONCLUSION: Long term intrathecal morphine therapy is a useful treatment option for patients with
intractable severe RSD who have failed other therapies and remain markedly disabled.
J Neurosurg. 1990 Feb;72(2):200-9. Long-term pain relief produced by intrathecal morphine infusion in 53 patients. Onofrio BM, Yaksh TL. Department of
Neurologic Surgery, Mayo Clinic, Rochester, Minnesota. The present report details the characteristics of the analgesic effects of morphine administered
chronically by infusion pumps implanted in 53 patients suffering from terminal metastatic disease. The median postimplant survival time in these patients
was 4 months. Patients (mean age 58 years) were characterized according to the duration of pain before pump implantation (mean 16 months), prior
consumption of systemic opioids (mean one to six daily analgesic equivalents of morphine), and their response to a trial intrathecal dose of morphine (1 to 2
mg). The median infusion dose at 2 weeks was 3.8 mg/day. The analgesic index, calculated as (quality of pain relief x duration of pain relief in
hours)/morphine dose in mg, that was observed after the trial dose of morphine was determined for each patient. A close correlation was observed between
the acute (2-week) infusion dose necessary to produce pain relief and the analgesic index such that the infusion dose = -8.0 x log (analgesic index) + 17.1.
By 16 weeks, the mean spinal morphine dose for the group had increased by a factor of about 2.5; however, significant variation in the dose incrementation
was documented. The maximum increase was observed in patients with a low analgesic index, and this rapid incrementation was usually correlated with an
unsatisfactory overall outcome. Evidence that long-term infusion continues to yield analgesia was evidenced in six cases where there was an unanticipated
loss of drug infusion and a corresponding increase in parenteral narcotic consumption. These data indicate the long-term efficacy and safety of spinal opioid
infusion in patients with terminal cancer, and emphasize the advantage of assessing the sensitivity of the patient to spinal opioids by a standardized trial
injection prior to pump placement as a prognostic indication of outcome
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