Polyanalgesic Consensus Conference-2012: Recommendations to Reduce Morbidity and Mortality in Intrathecal Drug Delivery in the Treatment of Chronic Pain.

Johns Hopkins University, Baltimore, MD, USA
Neuromodulation (Impact Factor: 1.79). 07/2012; 15(5):467-482. DOI: 10.1111/j.1525-1403.2012.00486.x
Source: PubMed

ABSTRACT Introduction:  Targeted intrathecal drug infusion to treat moderate to severe chronic pain has become a standard part of treatment algorithms when more conservative options fail. This therapy is well established in the literature, has shown efficacy, and is an important tool for the treatment of both cancer and noncancer pain; however, it has become clear in recent years that intrathecal drug delivery is associated with risks for serious morbidity and mortality. Methods:  The Polyanalgesic Consensus Conference is a meeting of experienced implanting physicians who strive to improve care in those receiving implantable devices. Employing data generated through an extensive literature search combined with clinical experience, this work group formulated recommendations regarding awareness, education, and mitigation of the morbidity and mortality associated with intrathecal therapy to establish best practices for targeted intrathecal drug delivery systems. Results:  Best practices for improved patient care and outcomes with targeted intrathecal infusion are recommended to minimize the risk of morbidity and mortality. Areas of focus include respiratory depression, infection, granuloma, device-related complications, endocrinopathies, and human error. Specific guidance is given with each of these issues and the general use of the therapy. Conclusions:  Targeted intrathecal drug delivery systems are associated with risks for morbidity and mortality that can be devastating. The panel has given guidance to treating physicians and healthcare providers to reduce the incidence of these problems and to improve outcomes when problems occur.


Available from: B. Todd Sitzman, Jun 24, 2014
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Chronic pain continues to pose substantial and growing challenges for patients, caregivers, health care professionals, and health care systems. By the time a patient with severe refractory pain sees a pain specialist for evaluation and management, that patient has likely tried and failed several nonpharmacologic and pharmacologic approaches to pain treatment. Although relegated to one of the interventions of "last resort", intrathecal drug delivery can be useful for improving pain control, optimizing patient functionality, and minimizing the use of systemic pain medications in appropriately selected patients. Due to its clinical and logistical requirements, however, intrathecal drug delivery may fit poorly into the classic pain clinic/interventional model and may be perceived as a "critical mass" intervention that is feasible only for large practices that have specialized staff and appropriate office resources. Potentially, intrathecal drug delivery may be more readily adopted into larger practices that can commit the necessary staff and resources to support patients' needs through the trialing, initiation, monitoring, maintenance, and troubleshooting phases of this therapy. Currently, two agents - morphine and ziconotide - are approved by the United States Food and Drug Administration for long-term intrathecal delivery. The efficacy and safety profiles of morphine have been assessed in long-term, open-label, and retrospective studies of >400 patients with chronic cancer and noncancer pain types. The efficacy and safety profiles of ziconotide have been assessed in three double-blind, placebo-controlled trials of 457 patients, and safety has been assessed in 1,254 patients overall, with severe chronic cancer, noncancer, and acquired immunodeficiency syndrome pain types. Both agents are highlighted as first-line intrathecal therapy for the management of neuropathic or nociceptive pain. The purpose of this review is to discuss practical considerations for intrathecal drug delivery, delineate criteria for the identification and selection of candidates for intrathecal drug delivery, and consider which agent may be more appropriate for individual patients.
    Journal of Pain Research 01/2014; 7:627-638. DOI:10.2147/JPR.S65441
  • [Show abstract] [Hide abstract]
    ABSTRACT: Objectives Intrathecal drug therapy is being utilized increasingly for the treatment of chronic refractory pain. However, performing the regular pump refill procedures caries the potential risk of medication injection into the subcutaneous tissue. The aim of this study was to assess the accuracy of this template-guided refill technique by means of fluoroscopic evaluation.Materials and Methods In 23 patients, the difference between the identification of the reservoir fill port center using the manufacturer's template and fluoroscopic guidance was assessed on four consecutive refill procedures by a two physicians. A distance surpassing that between the center and the margin of the port (3.5 mm) was considered a clinically relevant deviation. Analyses were performed with a one-sample t-test, with p < 0.05 indicating statistical significance.ResultsThe mean difference distance between identification markings of the target with fluoroscopic guidance and with the template was 8.2 mm, with limited variance (2.7 mm). For all individual refill procedures, the port center identification accuracy differed significantly from zero (all p < 0.001) and from the clinically relevant cut-off point of 3.5 mm (all p < 0.001). Only seven attempts (6.4%) were within the margins of the fill port.Conclusions Our results suggest poor accuracy of insertion point identification using the template. This highlights the potential risk of errors related to identification of the puncture site using the template-guided technique.
    Neuromodulation 09/2014; DOI:10.1111/ner.12212 · 1.79 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Dovepress 571 R E V I E W open access to scientific and medical research Open Access Full Text Article Abstract: The management of chronic pain can be very challenging. Often, physicians employ intrathecal (IT) drug delivery systems as a last resort to relieve intractable pain. The system consists of an implantable pump that stores and delivers medication through a catheter to the IT space. Programmability is achieved by positioning an external devise over the implanted pump to change the mode of drug delivery. The innovations in programmable IT drug delivery systems are expanding more rapidly than ever before. Unfortunately, the rapid expansion is accompanied by a lack of prospective randomized trials examining these new options. In an effort to improve results and reduce side effects, publications by experts or expert consensus panels provide guidance for the community. The purpose of this article is to provide a summary of high interest topics in recent publications.
    Journal of Pain Research 10/2014; 7. DOI:10.2147/JPR.S46929