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Abstract
Background and objectives Percutaneous peripheral nerve stimulation (PNS) is an analgesic modality involving the insertion of a lead through an introducing needle followed by the delivery of electric current. This modality has been reported to treat chronic pain as well as postoperative pain following knee and foot surgery. However, it remains unknown if this analgesic technique may be used in ambulatory patients following upper extremity surgery. The purpose of this proof-of-concept study was to investigate various lead implantation locations and evaluate the feasibility of using percutaneous brachial plexus PNS to treat surgical pain following ambulatory rotator cuff repair in the immediate postoperative period.
Methods Preoperatively, an electrical lead (SPR Therapeutics, Cleveland, Ohio) was percutaneously implanted to target the suprascapular nerve or brachial plexus roots or trunks using ultrasound guidance. Postoperatively, subjects received 5 min of either stimulation or sham in a randomized, double-masked fashion followed by a 5 min crossover period, and then continuous stimulation until lead removal postoperative days 14–28.
Results Leads (n=2) implanted at the suprascapular notch did not appear to provide analgesia, and subsequent leads (n=14) were inserted through the middle scalene muscle and placed to target the brachial plexus. Three subjects withdrew prior to data collection. Within the recovery room, stimulation did not decrease pain scores during the first 40 min of the remaining subjects with brachial plexus leads, regardless of which treatment subjects were randomized to initially. Seven of these 11 subjects required a single-injection interscalene nerve block for rescue analgesia prior to discharge. However, subsequent average resting and dynamic pain scores postoperative days 1–14 had a median of 1 or less on the Numeric Rating Scale, and opioid requirements averaged less than 1 tablet daily with active stimulation. Two leads dislodged during use and four fractured on withdrawal, but no infections, nerve injuries, or adverse sequelae were reported.
Conclusions This proof-of-concept study demonstrates that ultrasound-guided percutaneous PNS of the brachial plexus is feasible for ambulatory shoulder surgery, and although analgesia immediately following surgery does not appear to be as potent as local anesthetic-based peripheral nerve blocks, the study suggests that this modality may provide analgesia and decrease opioid requirements in the days following rotator cuff repair. Therefore, it suggests that a subsequent, large, randomized clinical trial with an adequate control group is warranted to further investigate this therapy in the management of surgical pain in the immediate postoperative period. However, multiple technical issues remain to be resolved, such as the optimal lead location, insertion technique, and stimulating protocol, as well as preventing lead dislodgment and fracture.
Trial registration number NCT02898103.
- neuromodulation:peripheral nerve stimulation
- postoperative pain
- acute pain
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Footnotes
Funding Funding for this project was provided by the University of California Academic Senate (San Diego, California) and the University of California San Diego Department of Anesthesiology (San Diego, California). SPR Therapeutics (Cleveland, Ohio) also provided the stimulators and leads used in this investigation. This company was given the opportunity to review the protocol and initial manuscript (minor revisions were suggested for each), but the investigators retained full control of the investigation, including study design, protocol implementation, data collection, analysis, and interpretation, and manuscript preparation.
Disclaimer The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the funding entities. None of the authors has a personal financial interest in this research.
Competing interests The University of California San Diego has received funding from SPR Therapeutics for other research studies of BMI, JJF, RAG, ETS, WBA, BK, JFS, MWS, PJ, DCC, and CMR.
Patient consent for publication Not required.
Ethics approval The study was approved by the UCSD Human Research Protections Program. This study adhered to Good Clinical Practice quality standards and ethical guidelines defined by the Declaration of Helsinki. Study protocol approval as well as data and safety oversight were conducted by the University of California San Diego Institutional Review Board (IRB #151094; San Diego, California). Written, informed consent was obtained from all subjects participating in the trial.
Provenance and peer review Not commissioned; externally peer reviewed.