Continuous Peripheral Nerve Blocks for Phantom Limb Pain
Trial Summary
What is the purpose of this trial?
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.
Research Team
Brian Ilfeld, MD
Principal Investigator
University California San Diego
Eligibility Criteria
This trial is for individuals scheduled for unilateral lower limb amputation who are willing to have a nerve block infusion for 7 days, including after hospital discharge. They must not have liver or kidney issues, allergies to study meds, be pregnant or incarcerated, and must be able to communicate with researchers.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Control continuous peripheral nerve blocks (Local Anesthetic)
- Experimental continuous peripheral nerve blocks (Local Anesthetic)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Wake Forest University Health Sciences
Collaborator
The Cleveland Clinic
Collaborator
Johns Hopkins University
Collaborator
Boston VA
Collaborator
Mass. General Hospital
Collaborator
Brigham and Women's Hospital
Collaborator
United States Department of Defense
Collaborator
United States Naval Medical Center, San Diego
Collaborator
Walter Reed National Military Medical Center
Collaborator