Continuous Peripheral Nerve Blocks for Phantom Limb Pain
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is continuous peripheral nerve block generally safe for humans?
Continuous peripheral nerve blocks (CPNBs) have been used in various medical settings, including orthopedic surgeries and battlefield anesthesia, with studies indicating they can be safe and effective for pain management. They may have fewer side effects compared to other pain relief methods, but like any medical procedure, they can have complications, so it's important to discuss potential risks with your healthcare provider.12345
How does the continuous peripheral nerve block treatment for phantom limb pain differ from other treatments?
Continuous peripheral nerve blocks are unique because they involve a 6-day infusion of a local anesthetic directly around the nerves, which helps disrupt the nerve pathways thought to cause phantom limb pain. This method is different from other treatments as it directly targets the nerves and has shown to reduce pain and improve physical and emotional function for at least a month.26789
What data supports the effectiveness of the treatment for phantom limb pain?
Research shows that a 6-day continuous peripheral nerve block can reduce phantom limb pain and improve physical and emotional well-being for at least one month after treatment. In a study, patients who received this treatment reported lower pain levels compared to those who received a placebo.268910
Who Is on the Research Team?
Brian Ilfeld, MD
Principal Investigator
University California San Diego
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive continuous peripheral nerve blocks (CPNB) with either bupivacaine or ropivacaine for pain management post-amputation
Follow-up
Participants are monitored for mobility, pain, and opioid consumption at various intervals post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- Control continuous peripheral nerve blocks
- Experimental continuous peripheral nerve blocks
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