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ACTIVE NOT RECRUITING
NCT03461120
PHASE4

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

View on ClinicalTrials.gov

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

DRUG

Experimental continuous peripheral nerve blocks

Bupivacaine 0.3% \[or ropivacaine 0.5%\] infusions for 7 days via femoral and sciatic perineural catheters

DRUG

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