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Improving Postamputation Functioning by Decreasing Phantom Pain With Perioperative Continuous Peripheral Nerve Blocks: A Department of Defense Funded Multicenter Study
Sponsor: University of California, San Diego
Summary
When a limb is amputated, pain perceived in the part of the body that no longer exists often develops, called "phantom limb" pain. The exact reason that phantom limb pain occurs is unclear, but when a nerve is cut-as happens with an amputation-changes occur in the brain and spinal cord that are associated with persistent pain. The negative feedback-loop between the injured limb and the brain can be stopped by putting local anesthetic-called a "nerve block"-on the injured nerve, effectively keeping any "bad signals" from reaching the brain. A "continuous peripheral nerve block" (CPNB) is a technique providing pain relief that involves inserting a tiny tube-smaller than a piece of spaghetti-through the skin and next to the target nerve. Local anesthetic is then introduced through the tiny tube, which bathes the nerve in the numbing medicine. This provides a multiple-day block that provides opioid-free pain control with no systemic side effects, and may prevent the destructive feedback loop that results in phantom limb pain following an amputation. We propose a multicenter, randomized, triple-masked (investigators, subjects, statisticians), placebo-controlled, parallel arm, human-subjects clinical trial to determine if a prolonged, high-concentration (dense), perioperative CPNB improves post-amputation physical and emotional functioning while decreasing opioid consumption, primarily by preventing chronic phantom limb pain.
Official title: Improving Postamputation Functioning by Decreasing Phantom Limb Pain and Opioid Use With Perioperative Continuous Peripheral Nerve Blocks: A Multicenter RCT
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
203
Start Date
2018-03-23
Completion Date
2026-11-18
Last Updated
2025-10-20
Healthy Volunteers
No
Interventions
Experimental continuous peripheral nerve blocks
Bupivacaine 0.3% \[or ropivacaine 0.5%\] infusions for 7 days via femoral and sciatic perineural catheters
Control continuous peripheral nerve blocks
Bupivacaine 0.1% \[or ropivacaine 0.2%\] infusions for 1 day followed by normal saline for a total of 7 days via femoral and sciatic perineural catheters
Locations (8)
University California San Diego
San Diego, California, United States
Naval Medical Center San Diego
San Diego, California, United States
Mass. General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston VA
Boston, Massachusetts, United States
Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States