Intrathecal Baclofen Therapy in Patients With Multiple Sclerosis: Improved Outcomes and Reduced Costs Through Identification of Catheter Malfunction.

INTRODUCTION: Two patients previously implanted with intrathecal Baclofen (ITB) pumps for management of intractable spasticity due to multiple sclerosis (MS) were referred to our center for ongoing management of their spasticity. Initial evaluation of these patients revealed high levels of spasticity in the presence of ITB doses 10 times the average daily dose of our other MS patients. CLINICAL FACTS: High doses of ITB required frequent clinical visits and result in high drug and procedure costs. Both patients' daily doses were greater than 1000 mcg/day resulting in clinical visits every 1-2 months with drug and procedure costs ranging from 16 to 23 thousand dollars annually based on Medicare national average pricing for physician's office. Of the 59 MS patients receiving ITB therapy at our institution, the mean, median, and mode daily doses for ITB are 184, 115, and 159 mcg/day, respectively. The high ITB doses in these patients and poor spasticity control raised suspicion for pump/catheter malfunction and prompted immediate troubleshooting. FINDINGS: One patient's catheter was found to be disconnected from the pump and the other's catheter tip was outside the intrathecal space. In both cases, the patients were not receiving the therapy. After pump/catheter replacement, both patients received excellent clinical benefits from ITB at significantly lower daily doses. This reduction in dose resulted in decreased frequency of medication refills (twice annually) which resulted in decreased cost of care (12-19 thousand dollars savings annually per patient). DISCUSSION: These cases illustrate the need for early ITB pump troubleshooting to identify catheter problems, improve efficacy, and avoid unnecessary healthcare costs.

The Development and Validation of a Quality Assessment and Rating of Technique for Injections of the Spine (AQUARIUS).

BACKGROUND AND OBJECTIVES: Systematic reviews evaluate the utility of procedural interventions of the spine, including epidural steroid injections (ESIs). However, existing quality assessment tools either fail to account for proper technical quality and patient selection or are not validated. We developed and validated a simple scale for ESIs to provide a quality assessment and rating of technique for injections of the spine (AQUARIUS). METHODS: Seven experts generated items iteratively based on prior ESI technique studies and professional judgment. Following testing for face and content validity, a 17-item instrument was used by 8 raters from 2 different backgrounds to assess 12 randomized controlled trials, selected from 3 different categories. Using frequency of assessment, a 12-item instrument was also generated. Both instruments underwent reliability (intraclass correlation coefficient), validity (ability to distinguish "low," "random," and "high" study categories), and diagnostic accuracy (receiver operating characteristics) testing. RESULTS: Both 17- and 12-item instruments were scored consistently by raters regardless of background, with overall intraclass correlation coefficients of 0.72 (95% confidence interval [CI], 0.53-0.89) and 0.71 (95% CI, 0.51-0.89), respectively. Both instruments discriminated between clinical trials from all 3 categories. Diagnostic accuracy was similar for the 2 instruments, with areas under receiver operating characteristic curves of 0.89 (95% CI, 0.82-0.96) and 0.90 (95% CI, 0.82-0.97), respectively. CONCLUSIONS: The instrument in both 17- and 12-item formats demonstrates good reliability and diagnostic accuracy in rating ESI studies. As a complement to other tools that assess bias, the instrument may improve the ability to evaluate evidence for systematic reviews and improve clinical trial design.

Spinal injections: medico-legal and insurance considerations.

A series of serious accidents following spinal, cervical and lumbar foraminal injections has led French medical insurers to start discussions with professional radiologists to ask us to take the necessary measures allowing them to continue to cover the exceptional but considerable risks of these interventional radiology procedures. This article summarises the facts and the insurers' recommendations and insists on the need to adopt a new and permanent strategy to improve the quality and safety of our practice.

Respiratory failure following delayed intrathecal morphine pump refill: a valuable, but costly lesson.

BACKGROUND: Spinal analgesia, mediated by opioid receptors, requires only a fraction of the opioid dose that is needed systemically. By infusing a small amount of opioid into the cerebrospinal fluid in close proximity to the receptor sites in the spinal cord, profound analgesia may be achieved while sparing some of the side effects due to systemic opioids. Intraspinal drug delivery (IDD) has been increasingly used in patients with intractable chronic pain, when these patients have developed untoward side effects with systemic opioid usage. The introduction of intrathecal opioids has been considered one of the most important breakthroughs in pain management in the past three decades. A variety of side effects associated with the long-term usage of IDD have been recognized. Among them, respiratory depression is the most feared. OBJECTIVE: To describe a severe adverse event, i.e., respiratory failure, following delayed intrathecal morphine pump refill. CASE REPORT: A 65-year-old woman with intractable chronic low back pain, due to degenerative disc disease, and was referred to our clinic for an intraspinal drug delivery evaluation, after failing to respond to multidisciplinary pain treatment. Following a psychological evaluation confirming her candidacy, she underwent an outpatient patient-controlled continuous epidural morphine infusion trial. The infusion trial lasted 12 days and was beneficial in controlling her pain. The patient reported more than 90% pain reduction with improved distance for ambulation. She subsequently consented and was scheduled for permanent intrathecal morphine pump implantation. The intrathecal catheter was inserted at right paramedian L3-L4, with catheter tip advanced to L1, confirmed under fluoroscopy. Intrathecal catheter placement was confirmed by positive CSF flow and by myelogram. A non-programmable Codman 3000 constant-flow rate infusion pump was placed in the right mid quandrant between right rib cage and right iliac crest. The intrathecal infusion consisted of preservative free morphine, delivering 1.0 mg /day. Over the following 6 months, the dosage was gradually titrated up to 4 mg/day with satisfactory pain control without significant side effects. However, the patient was not able to return to the clinic for pump refill until 12 days later than the previously scheduled pump-refill date. Her pump was accessed and was noted to be empty. Her intrathecal pump was refilled with preservative free morphine, delivering 4 mg/day (the same daily dose as her previous refill). However, on the night of pump refill, 10 hours after the pump refill, the patient was found to be unresponsive by her family members. 911 was called. Upon arriving, paramedics found her in respiratory failure, with shallow breathing at a rate of 5/min, pulse oxymetry showing oxygen saturation about 55-58%. She was emergently intubated on site and rushed to local hospital ER. The on call physician for our clinic was immediately contacted, and advised the administration of intravenous Naloxone. Her respiratory effort improved dramatically after receiving a total of 0.6 mg IV Naloxone IV over 25 minutes. Her intrathecal pump was immediately accessed by clinic on call physician and the remainder of the medication in the catheter space was aspirated. The pump infusate was immediately diluted with preservative free normal saline, to deliver preservative free morphine at 1mg/day. She was transferred to the intensive care unit and extubated the next morning. She recovered fully without any sequelae. CONCLUSION: Loss of opioid tolerance due to delayed pump refill may subject patients to the development of severe respiratory depression. Meticulous approach should be employed when refilling pumps in these patients when their pumps are completely empty. To our knowledge, this is the first reported case of this type.

Patient experiences of pain and pain management at the end of life: a pilot study.

Cancer pain is a difficult symptom for patients to handle, causing patients extreme discomfort and a decreased quality of life. To support independent pain control for patients with refractory pain while staying in their home, an intrathecal approach for continuous pain management with patient-controlled extra doses from an external pump was implemented. Pain management was supported by a structured guideline for the nursing interventions: To enhance the understanding of how the patients experienced their pain and the continuous pain management at the end of life, a pilot study was conducted. The study followed a qualitative design with unstructured tape-recorded interviews. Three themes emerged from the analysis: (1) The pain was dreadful, reminding the patient of the cancer and the uncertainty of the future; (2) the need to reveal and conceal pain coexisted; and (3) the pain management and structured guideline contributed positively to gain a new perspective on health in which pain did not play the central role. The conclusion is that patients need to communicate their experiences of the pain to manage the pain adequately, while at the same time they need to conceal it to manage their everyday environment. Forthcoming research will focus on the relation between the pain and the way patients experience cancer and on the experience and specific needs of their family.

Drug delivery systems.

Intrathecal drug delivery (IDD) is a proven and effective treatment alternative in carefully selected patients with chronic pain that cannot be controlled by a well-tailored drug regime and/or spinal cord stimulation (SCS), and may be specifically trialed in patients who fail to respond to SCS. While the lack of randomized controlled trials is often perceived as a limitation of IDD, many studies attest to the efficacy of this therapy, and a number are large-scale and with follow-up periods of up to five years. Good to excellent pain relief is achieved in many patients who have failed more conservative therapies, and there is often a reduced need for analgesia. The advent of patient-controlled analgesia allows flexibility of dosing according to the patient's needs. Consequently, quality of life improves in many patients and the majority express satisfaction with treatment. Some patients are able to return to work. The benefits of IDD (including a potent analgesic response with a more stable therapeutic drug level, decreased latency, increased duration of action, and decreased pharmacological complications) mean that side effects such as nausea, vomiting, sedation, and constipation are reduced. In addition, IDD demonstrates long-term cost-effectiveness when compared to conventional pain therapies, addressing a concern that affects many physicians in clinical practice today.