ziconotide and Postoperative-Complications

The aim of this open-label, non-randomized, clinical trial was to evaluate the feasibility of trialing ziconotide by intrathecal bolus injections.. Twenty-three patients, who had peripheral neuropathic pain refractory to pharmacological treatment and were under consideration for Spinal Cord Stimulation, received up to three ziconotide bolus injections according to a comprehensive algorithm. After a first injection of 2.5 μg, the patients progressed in the algorithm depending on the presence or absence of pain reduction and significant adverse events. A patient was considered a "responder" if experiencing pain reduction and no significant adverse event on two consecutive occasions at the same dosage.. We found a low proportion of responders (13%). However 30% of patients experienced ≥30% pain reduction on a least one injection, yielding a number needed to treat of ∼3 for clinically significant pain relief. Pain intensity changed significantly over time (0-6 h) (p = 0.047) after a mean ziconotide dose of 2.75 μg. Adverse events were as expected, and no serious adverse event occurred. We did not find any statistical association between response to Spinal Cord Stimulation and response to ziconotide.. Ziconotide bolus injection trialing seems feasible, but the proportion of responders in the present study was low. Adverse events were as expected, and no serious adverse event occurred. The predictive power of ziconotide bolus trialing remains unclear, and the pharmacological profile of ziconotide (slow tissue penetration due to high hydrophilicity) calls the rationale for bolus trialing into question.

Topics: Adult; Aged; Aged, 80 and over; Analgesics, Non-Narcotic; Female; Humans; Injections, Spinal; Male; Middle Aged; Neuralgia; omega-Conotoxins; Pain Measurement; Postoperative Complications; Treatment Outcome

The formation of catheter tip granulomas is an increasingly observed serious complication of intrathecally administered medication. This complication, which is frequently associated with neurological disturbances, has previously been attributed to high dosages and high concentrations of intrathecal morphine. Much less commonly, intrathecal hydromorphone and intrathecal baclofen have also been associated with intrathecal granuloma formation. In the current case, we report a patient who developed her fi rst catheter tip granuloma after 20 months of intrathecal morphine. After surgical granuloma removal and installation of a new catheter, the patient received intrathecal ziconitide for an interim period of six months. Because of a progressive inefficacy, ziconitide was replaced by hydromorphone. One month later, only nine months after the fi rst operative granuloma removal, a new catheter tip granuloma required a further surgical intervention. This case report highlights the potential of intrathecal morphine and hydromorphone to form consecutive inflammatory granulomas within the same patient. To the best of our knowledge, this is the fi rst report of a patient developing two consecutive catheter tip granulomas within nine months.

Topics: Analgesics, Non-Narcotic; Analgesics, Opioid; Catheterization; Female; Granuloma; Humans; Hydromorphone; Injections, Spinal; Laminectomy; Low Back Pain; Magnetic Resonance Imaging; Middle Aged; Morphine; omega-Conotoxins; Orthopedic Procedures; Postoperative Complications; Recurrence; Spinal Diseases