A Prospective, Randomized, Single-Blinded, Head-to-Head Long-Term Outcome Study, Comparing Intrathecal (IT) Boluses With Continuous Infusion Trialing Techniques Prior to Implantation of Drug Delivery Systems (DDS) for the Treatment of Severe Intractable Chronic Nonmalignant Pain

作者：Hamza Maged; Doleys Daniel M; Saleh Islam A; Medvedovsky Andrew; Verdolin Michael H; Hamza Monalyce

来源：Neuromodulation, 2015, 18(7): 636-649.

DOI：10.1111/ner.12342

• Controlled study
• intrathecal drug delivery
• nonmalignant pain
• placebo controlled
• prospective
• randomized
• trialing for pump implant

ObjectiveThe study aims to compare intrathecal (IT) boluses to continuous infusion trialing techniques prior to implantation of drug delivery systems (DDS) for the treatment of severe intractable chronic nonmalignant pain.
DesignThis is a prospective, randomized, head-to-head long-term outcome study.
Materials and MethodsForty patients with comparable patient demographics were randomly assigned to two cohorts. Cohort A trialed with intermittent boluses; Cohort B trialed with continuous infusion. One patient failed trial in each group. Nineteen patients were implanted in each group. Follow-up was for 36 months with intervals at 6, 12, 18, 24, 36 months. The Brief Pain Inventory was used was used for assessment.
Outcome MeasuresWe used the Brief Pain Inventory to measure pain (worst and average), physical walking, normal work, and general activity), behavioral mood, sleep, and relations with others), IT dose, and oral opioid use.
ResultsWe observed statistically significant reduction in pain and improvement of function in both cohorts following DDS implantation throughout the observation period. The IT dose remained virtually unchanged throughout as well, with overall limited dose escalation. Oral opioid use was significantly reduced. There was no statistically significant difference in prediction of trial success or long-term outcomes between the two cohorts.
ConclusionLow-dose IT opioids via DDS can provide significant and long-lasting reduction in pain, and improvement in physical and behavioral) for patients with chronic nonmalignant pain. The two trialing techniques tested, intermittent boluses, and continuous infusion delivered intrathecally showed no clinical significance difference in terms of predicting trial success or long-term outcomes.

• 出版日期2015-10