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Percutaneous Neuromodulation of the Brachial Plexus and Sciatic Nerve for the Treatment of Acute Pain Following Surgery: Secondary Outcomes From a Multicenter, Randomized, Controlled Pilot Study

July 27, 2023

Objectives:
We recently reported that percutaneous peripheral nerve stimulation (PNS or “neuromodulation”) decreased pain and opioid consumption within the first two weeks following ambulatory surgery. However, the anatomic lead locations were combined for the analysis, and benefits for each location remain unknown. We therefore now report the effects of percutaneous PNS for brachial plexus and sciatic nerve leads separately.
Materials and Methods: Before surgery, leads were implanted percutaneously to target the brachial plexus (N = 21) for rotator cuff repair or sciatic nerve (N = 40) for foot/ankle surgery, followed by a single injection of local anesthetic. Postoperatively, subjects were randomized in a double masked fashion to 14 days of electrical stimulation (N = 30) or sham/placebo (N = 31) using an external pulse generator. The primary outcome of interest was opioid consumption and pain scores evaluated jointly. Thus, stimulation was deemed effective if superior on either outcome and at least noninferior on the other.
Results:
For brachial plexus leads, during the first seven postoperative days pain measured with the numeric rating scale in participants given active stimulation was a median [interquartile range] of 0.8 [0.5, 1.6] versus 3.2 [2.7, 3.5] in patients given sham (p < 0.001). For this same group, opioid consumption in participants given active stimulation was 10 mg [5, 20] versus 71 mg [35, 125] in patients given sham (p = 0.043). For sciatic nerve leads, pain scores for the active treatment group were 0.7 [0, 1.4] versus 2.8 [1.6, 4.6] in patients given sham (p < 0.001). During this same period, participants given active stimulation consumed 5 mg [0, 30] of opioids versus 40 mg [20, 105] in patients given sham (p = 0.004). Treatment effects did not differ statistically between the two locations. Conclusions:
Ambulatory percutaneous PNS of both the brachial plexus and sciatic nerve is an effective treatment for acute pain free of systemic side effects following painful orthopedic surgery.
Keywords:
Ambulatory surgery, percutaneous peripheral nerve stimulation, postoperative analgesia, regional anesthesia, ultrasound-guided regional anesthesia
Conflict of Interest:
Harold Gelfand is participating in Henry Jackson Foundation (Bethesda, MD) funded research through a grant from Pacira Pharmaceuticals (Parsippany, NJ). Brian M. Ilfeld’s institution has received funding for other research from Infutronix (Natick, MA), Epimed International (Farmers Branch, TX), and SPR Therapeutics (Cleveland, OH). Daniel I. Sessler serves as a consultant for Pacira Pharmaceuticals (Parsippany, NJ). The author’s institution receives funding from Pacira Pharmaceuticals (Parsippany, NJ) and Heron Therapeutics (San Diego, CA). Alparslan Turan’s institution receives funding from Pacira Pharma- ceuticals (Parsippany, NJ) and Heron Therapeutics (San Diego, CA). Joseph W. Boggs and Amorn Wongsarnpigoon are employees of SPR Therapeutics, the manufacturer of the electrical leads and pulse generators under investigation in this study. Both authors own stock options in this company. Of note, this was an investigator-initiated project fully funded by the U.S. Department of Defense, and the first author retained complete control of the grant proposal, study protocol, data collection, analysis, and interpretation, and the resulting manuscript. Drs Boggs and Wongsarnpigoon were provided the initial protocol on which to comment, with some suggested revisions incorporated into the protocol while others were not. The remaining authors report no conflicts.