Status:
COMPLETED
Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Multicenter Pilot Study
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Uniformed Services University of the Health Sciences
Walter Reed National Military Medical Center
Conditions:
Rotator Cuff Repair
Anterior Cruciate Ligament Reconstruction
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 pilot or feasibility study (designated as UG3 by the Department of Defense) which will be a randomized, double-masked, placebo-controlled, parallel-arm, human subjects pilot study with two S...
Eligibility Criteria
Inclusion
- 18 years of age or older
- undergoing one of the following surgical procedures: rotator cuff repair, anterior cruciate ligament repair with a patellar autograph, 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 :
July 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2021
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03481725
Start Date
July 14 2018
End Date
January 7 2021
Last Update
March 18 2021
Active Locations (6)
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1
University California San Diego
San Diego, California, United States, 92103
2
Naval Medical Center San Diego
San Diego, California, United States, 92134
3
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
4
Womack Army medical Center
Fort Bragg, North Carolina, United States, 28310