Original Contributions
Complications of Intrathecal Drug Delivery Systems

https://doi.org/10.1046/j.1525-1403.2001.00111.xGet rights and content

ABSTRACT

Objectives

To report complications associated with implant of the intrathecal drug delivery systems (IDDS).

Patients and Methods

A retrospective review of the implant database was undertaken to determine various complications associated with the IDDS. A total of 122 patients were reviewed, 97 included in the final analysis, 25 excluded due to incomplete data. The complications of excluded patients were reviewed separately. The complications were divided in to categories pharmacologic, equipment, procedural, programming errors and psychological. The drugs used were morphine, dilaudid, fentanyl, sufentanil, baclofen, and marcaine.

Results

There were 60 men and 37 women. A total of 43 patients reported various complications. Most common were transient pharmacologic side effects (n= 33), procedural (n= 5), equipment (n= 16), programming (n= 2), and psychological (n= 3). The most serious procedural complication was Staphylococcus aureus meningitis (n= 1). Catheter disconnection and leakage was noted in (n= 6) patients. Two programming errors were related to increase in drug concentration with failure to reduce the dose. Seven pumps were explanted, including three due to distorted body image.

Conclusion

IDDS are effective and safe devices for pain management. The complications associated with implants are mostly pharmacological and transient.

Section snippets

INTRODUCTION

Although systemic opioids are effective in nonmalignant pain management, they can be associated with significant side effects (1). The majority of adverse drug reactions are dose-related and occur in patients taking standard doses of medications. These facts suggest that for many patients, standard drug doses may be excessive. Moreover, oral medications may not be effective in controlling pain. The efficacy and cost effectiveness of intrathecal medications for the treatment of chronic pain is

PATIENTS AND METHODS

We retrospectively reviewed our pump implant database for complications related to the implantation of intrathecal drug delivery systems. One physician (BW) performed all implants and another physician (SK) and a nurse collected data. Data collection involved filling a detailed questionnaire that included a section for pharmacologic side effects. In addition to the questionnaire, patients were interviewed prior to pump refills or dose adjustments. A physician not involved in device implantation

RESULTS

The pump implant database involved 122 patients. Twenty-five (n= 25) patients were excluded because of loss to follow-up/transfer of care to another area (n= 5), pump implanted at other facilities/operative data not available (n= 12) and pump implants prior to 1991 (database incomplete) (n= 8). Data on the excluded patients were reviewed separately. Ninety-seven patients from 1992 to 1999 were included in the study. There were 60 men and 37 women with age range of 28–85 years. Average follow up

DISCUSSION

Though a large number of small series regarding IDDS have been reported, there are only a few large studies describing the complications of intrathecal drug delivery systems (4,9., 10., 11.). We report one of the largest single implanter/facility series of complications associated with intrathecal drug delivery system implants. As more pumps are implanted, physicians have to become familiar with the potential complications associated with the procedure. The purpose of this study was to report a

CONCLUSION

IDDS is very effective for chronic pain management in appropriately selected patients. The complications associated with IDDS are mostly pharmacologic and transient. With equipment improvement, meticulous attention to the implant technique, and a better understanding of the intrathecal drugs, complications can be significantly reduced.

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