Improving Postamputation Functioning by Decreasing Phantom Pain With Perioperative Continuous Peripheral Nerve Blocks: A Department of Defense Funded Multicenter Study

• Status: Enrolling by invitation
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborators: Boston VA; Brigham and Women's Hospital; Johns Hopkins University; Mass. General Hospital; The Cleveland Clinic; United States Department of Defense; United States Naval Medical Center, San Diego; University of Texas MD Anderson; VA Pittsburgh Healthcare System; Wake Forest Medical Center; Walter Reed National Military Medical Center
• Treatments: Anesthetics; Anesthetics, Local; Bupivacaine

Criteria

Inclusion Criteria:

• scheduled for a unilateral lower limb amputation distal to the femoral head and including at least one metatarsal bone

• continuous peripheral nerve blocks are planned for perioperative analgesia

• willing to have their perineural infusion extended for a total of 7 days

• willing to undergo ambulatory perineural infusion following hospital discharge

Exclusion Criteria:

• Known hepatic or renal insufficiency

• allergy to any study medication

• pregnancy

• incarceration

• inability to communicate with the investigators

• comorbidity precluding either perineural catheter insertion or subsequent ambulatory perineural infusion (e.g., current infection at the catheter insertion site, immune-compromised status of any etiology)

• weight < 45 kg

• inability to contact the investigators during the perineural infusion, and vice versa (e.g., lack of telephone access)

• investigator opinion that the potential subject is not a good candidate for this particular study