Improving Postamputation Functioning by Decreasing Phantom Pain With Perioperative Continuous Peripheral Nerve Blocks: A Department of Defense Funded Multicenter Study
Running, not enrolling · Phase 4
Conditions studied: Lower Extremity Surgical Amputation, Post-amputation Phantom Limb Pain
In brief
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.
Key facts
- Study ID
- NCT03461120
- Run by
- University of California, San Diego
- People needed
- 203
- Starts
- 2018-03-23
- Expected to finish
- 2026-11-18
- Last updated by the study team
- 2025-10-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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