Continuous Peripheral Nerve Blocks for Phantom Limb Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a treatment to manage phantom limb pain, the sensation of pain in an amputated limb. The method under investigation is continuous peripheral nerve blocks (CPNB), which uses numbing medicine to block pain signals from reaching the brain and potentially reduce opioid use. Participants will receive either a standard or experimental dose to determine which is more effective in improving post-amputation recovery. The study seeks participants scheduled for a lower limb amputation who are willing to use this pain management method for seven days after surgery. As a Phase 4 trial, it involves an FDA-approved treatment and aims to understand how it can benefit more patients.
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.
What is the safety track record for continuous peripheral nerve blocks?
Previous studies have shown that continuous peripheral nerve blocks (CPNB) are safe and well-tolerated. These studies found that CPNB significantly reduces phantom limb pain and improves both physical and emotional health for at least a month after treatment. No major side effects affected the whole body, indicating the treatment only impacts the area around the nerve.
Patients experienced less pain with CPNB, and it more than doubled the chance of a noticeable reduction in pain. This evidence suggests that the treatment is generally safe for those dealing with phantom limb pain after an amputation.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the continuous peripheral nerve blocks for phantom limb pain because they offer a targeted approach to pain management. Unlike traditional treatments like oral painkillers or antidepressants, these nerve blocks use bupivacaine or ropivacaine, which are administered directly through perineural catheters to numb the affected area. The experimental treatment uses a higher concentration of these anesthetics over a full seven days, potentially providing more sustained relief. This method could offer quicker and more effective pain reduction, improving the quality of life for those suffering from phantom limb pain.
What evidence suggests that continuous peripheral nerve blocks are effective for phantom limb pain?
Research has shown that continuous peripheral nerve blocks (CPNB) can greatly reduce phantom limb pain. In this trial, participants will join different treatment arms to evaluate CPNB's effectiveness. One arm will receive a control infusion of Bupivacaine 0.1% or Ropivacaine 0.2% for one day, followed by normal saline. The other arm will receive an experimental infusion of Bupivacaine 0.3% or Ropivacaine 0.5% for seven days. Previous studies found that using CPNB for six days helped lessen both physical and emotional problems for at least a month. Another study revealed that this treatment more than doubled the chances of significant pain relief for those with phantom limb pain. Some patients even experienced complete pain relief soon after the nerve block, with effects lasting up to seven months. These findings suggest that CPNB is a promising way to manage phantom limb pain after amputation.12346
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
Massachusetts General Hospital
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