Status:
COMPLETED
Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Pragmatic Clinical Trial
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Congressionally Directed Medical Research Programs
Conditions:
Rotator Cuff Repair
Ankle Arthroplasty or Arthrodesis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
This is a multicenter, randomized, quadruple-masked, placebo-controlled, parallel-arm pragmatic clinical trial to determine the effects of percutaneous PNS on postoperative analgesia and opioid requir...
Eligibility Criteria
Inclusion
- 18 years of age or older.
- Undergoing one of the following surgical procedures: rotator cuff repair, ankle arthrodesis or arthroplasty, hallux valgus correction.
- With a planned single-injection peripheral nerve block for postoperative analgesia.
Exclusion
- Chronic analgesic use including opioids (daily use within the 2 weeks prior to surgery and duration of use \> 4 weeks).
- Neuro-muscular deficit of the target nerve(s).
- Compromised immune system based on medical history (e.g., immunosuppressive therapies such as chemotherapy, radiation, sepsis, infection), or other conditions that places the subject at increased risk.
- Implanted spinal cord stimulator, cardiac pacemaker/defibrillator, deep brain stimulator, or other implantable neurostimulator whose stimulus current pathway may overlap.
- History of bleeding disorder.
- Antiplatelet or anticoagulation therapies other than aspirin due to the risk of bleeding with a 20-gauge insertion needle.
- Allergy to skin-contact materials (occlusive dressings, bandages, tape etc.)
- Incarceration.
- Pregnancy.
- Chronic pain of greater than 3 months of any severity in an anatomic location other than the surgical extremity.
- Anxiety disorder.
- History of substance abuse.
- Inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access).
Key Trial Info
Start Date :
January 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04713098
Start Date
January 26 2021
End Date
September 22 2025
Last Update
December 18 2025
Active Locations (6)
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1
Cedars- Sinai Medical Center
Los Angeles, California, United States, 90048
2
University of California, San Diego
San Diego, California, United States, 92103
3
Naval Medical Center San Diego
San Diego, California, United States, 92134
4
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889