Peripheral Nerve Stimulation for Postoperative Pain
Trial Summary
What is the purpose of this trial?
Postoperative pain is usually treated with opioids that have undesirable and sometimes dangerous side effects (e.g., vomiting and respiratory depression)-and yet over 80% of patients still experience inadequate pain relief. A novel, non-pharmacologic analgesic technique-percutaneous peripheral nerve stimulation (PNS)- holds extraordinary potential to greatly reduce or obviate opioid requirements and concurrently improve analgesia following painful surgery. This technique involves inserting an insulated electric lead adjacent to a target nerve through a needle prior to surgery using ultrasound guidance. Following surgery, a tiny electric current is delivered to the nerve resulting in potent pain control without any cognitive or adverse systemic side effects whatsoever. The electrical pulse generator (stimulator) is so small it is simply affixed to the patient's skin. The leads are already cleared by the US Food and Drug Administration to treat acute (postoperative) pain for up to 60 days; and, since percutaneous PNS may be provided on an outpatient basis, the technique holds the promise of providing potent analgesia outlasting the pain of surgery-in other words, the possibility of a painless, opioid-free recovery following surgery. The current project is a multicenter, randomized, quadruple-masked, placebo/sham-controlled, parallel-arm pragmatic clinical trial to determine the effects of percutaneous PNS on postoperative analgesia and opioid requirements, as well as physical and emotional functioning, the development of chronic pain, and ongoing quality of life.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have been using chronic pain medications like opioids daily in the two weeks before surgery.
What data supports the effectiveness of the treatment Percutaneous Peripheral Nerve Stimulation for postoperative pain?
Percutaneous Peripheral Nerve Stimulation (PNS) has been shown to help reduce pain and the need for opioids (strong painkillers) after surgery, based on studies that have used it for chronic pain and some early research on postoperative pain. While more research is needed, initial findings suggest it could be a promising option for managing pain after surgery.12345
Is peripheral nerve stimulation safe for humans?
How is percutaneous peripheral nerve stimulation different from other treatments for postoperative pain?
Percutaneous peripheral nerve stimulation is unique because it uses a small lead to deliver electric currents to nerves, providing pain relief without the need for drugs. Unlike traditional methods, it avoids side effects like motor blockade and sensory deficits, and it can be applied using ultrasound guidance for precise placement.12379
Research Team
Brian Ilfeld, MD
Principal Investigator
University of California, San Diego
Eligibility Criteria
This trial is for adults over 18 who are having surgery for bunions, rotator cuff repair, or ankle fusion and will receive a nerve block for pain. It's not open to those using daily painkillers recently, with bleeding disorders, pregnant women, substance abuse history, weakened immune systems, on certain blood thinners (except aspirin), prisoners, without phone access, allergic to skin-contact materials or with chronic pain elsewhere.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Lead Implantation
Preoperative insertion of percutaneous lead to target nerves under ultrasound guidance
Treatment
Participants receive either active or sham percutaneous peripheral nerve stimulation post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Percutaneous Peripheral Nerve Stimulation
- Sham
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Congressionally Directed Medical Research Programs
Collaborator