Treating Intractable Post Amputation Phantom Limb Pain with Ambulatory Continuous Peripheral Nerve Blocks
Abstract
This is a randomized, double-masked, placebo-controlled clinical trial. The results will not be available until the completion of enrollment and unmasking of treatment groups. Therefore, there are no results/findings to report at this juncture as we are still completing enrollment. The tasks of the no-cost extension Year 5 encompassed continued recruiting, enrollment and data collection: 131 subjects enrolled to date for all centers; 60 subjects provided crossover treatment; Amputee support group outreach, prosthetics groups outreach, and clinic outreach conducted; Data collection ongoing for all enrolled subjects; We have but 13 subjects left to enroll to complete the study, and we would have enrolled these final subjects by the end of the no-cost extension Year 5 except the hurricane that hit Puerto Rico this last summer knocked out the factory that makes the local anesthetic used in this study-ropivacaine-and, so our enrollment was halted because ropivacaine cannot be purchased in the United States. It is unclear when the factory will begin producing ropivacaine again; but, if it is not available by April 2018, we will consult with the Scientific Officer regarding the possibility of switching to a different long-acting local anesthetic-bupivacaine-for the final 13 subjects. The Department of Defense has approved a second no-cost extension year through December 24, 2018
Document Details
- Document Type
- Technical Report
- Publication Date
- Jan 01, 2018
- Accession Number
- AD1047002
Entities
People
- Brian M Ilfeld
Organizations
- University of California, San Diego