N/A
N=65
Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Multicenter Pilot Study
Rotator Cuff Repair · Anterior Cruciate Ligament Reconstruction · Ankle Arthrodesis or Arthroplasty · Hallux Valgus Correction
Bottom Line
View on ClinicalTrials.gov: NCT03481725 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Opioid Consumption During First Postoperative Week — 5.0; 47.5 mg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) (Device); SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable SHAM stimulator (SPR Therapeutics, Cleveland, Ohio) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Consumption During First Postoperative Week |
5.0; 47.5 | — |
| PRIMARY Average Pain During First Postoperative Week |
1.1; 3.1 | — |
| SECONDARY Opioid Consumption Individual Time Points |
0; 15; 5; 20; 0; 10 | — |
| SECONDARY Brief Pain Inventory, Short Form (Interference Domain) |
2.6; 21.5; 2.5; 19.0; 4.0; 6.2 | — |
| SECONDARY Average Pain at Individual Time Points |
1.8; 4.0; 1.3; 3.9; 0.9; 3.1 | — |
| SECONDARY Worst Pain at Individual Time Points |
4; 7.8; 4; 7.5; 3; 6 | — |
| SECONDARY Least Pain at Individual Time Points |
0.2; 1.4; 0.2; 0.7; 0.1; 0.5 | — |
| SECONDARY Current Pain at Individual Time Points |
0.4; 2.3; 0.3; 1.5; 0.3; 1.0 | — |
| SECONDARY Defense and Veterans Pain Rating Score |
1.4; 4.2; 1.1; 2.9; 1.3; 1.5 | — |
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 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, double-masked, placebo-controlled, parallel-arm clinical pilot study to (1) determine the feasibility and optimize the protocol of a planned definitive clinical trial; and (2) estimate the treatment effect of percutaneous PNS on pain and opioid consumption following moderate-to-severely painful ambulatory surgery compared with usual and customary opioid-based analgesia. This will allow determination of the required sample size for a subsequent definitive multicenter clinical trial. Combined, the pilot study and definitive trial have a strong potential to dramatically reduce or obviate postoperative opioid requirements and their resultant negative effects on both individuals and society; while concurrently improving analgesia, increasing the ability to function in daily life, decreasing the risk of transition from acute to chronic pain, and improving quality of life.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT03481725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.