Percutaneous auricular neuromodulation (nerve stimulation) for the treatment of pain following cholecystectomy and hernia repair: a randomized, double-masked, sham-controlled pilot study.

Autor:	Ilfeld BM; Anesthesiology, University of California San Diego, La Jolla, California, USA bilfeld@health.ucsd.edu.; Outcomes Research, Cleveland Clinic, Cleveland, Ohio, USA., Abramson WB; Anesthesiology, University of California San Diego, La Jolla, California, USA., Alexander B; Anesthesiology, University of California San Diego, La Jolla, California, USA., Sztain JF; Anesthesiology, University of California San Diego, La Jolla, California, USA., Said ET; Anesthesiology, University of California San Diego, La Jolla, California, USA., Broderick RC; Department of Surgery, University of California San Diego, La Jolla, California, USA., Sandler BJ; Department of Surgery, University of California San Diego, La Jolla, California, USA., Doucet JJ; Department of Surgery, University of California San Diego, La Jolla, California, USA., Adams LM; Department of Surgery, University of California San Diego, La Jolla, California, USA., Abdullah B; Anesthesiology, University of California San Diego, La Jolla, California, USA., Cha BJ; Anesthesiology, University of California San Diego, La Jolla, California, USA., Finneran JJ 4th; Anesthesiology, University of California San Diego, La Jolla, California, USA.; Outcomes Research, Cleveland Clinic, Cleveland, Ohio, USA.
Jazyk:	angličtina
Zdroj:	Regional anesthesia and pain medicine [Reg Anesth Pain Med] 2024 Sep 02; Vol. 49 (9), pp. 628-634. Date of Electronic Publication: 2024 Sep 02.
DOI:	10.1136/rapm-2024-105283
Abstrakt:	Background: Percutaneous auricular nerve stimulation (neuromodulation) involves implanting electrodes around the ear and administering an electric current. A device is currently available within the USA cleared to treat symptoms from opioid withdrawal, and multiple reports suggest a possible postoperative analgesic effect. The current randomized controlled pilot study was undertaken to (1) determine the feasibility and optimize the protocol for a subsequent definitive clinical trial; and (2) estimate the treatment effect of auricular neuromodulation on postoperative pain and opioid consumption following two ambulatory surgical procedures. Methods: Within the recovery room following cholecystectomy or hernia repair, an auricular neuromodulation device (NSS-2 Bridge, Masimo, Irvine, California, USA) was applied. Participants were randomized to 5 days of either electrical stimulation or sham in a double-blinded fashion. Results: In the first 5 days, the median (IQR) pain level for active stimulation (n=15) was 0.6 (0.3-2.4) vs 2.6 (1.1-3.7) for the sham group (n=15) (p=0.041). Concurrently, the median oxycodone use for the active stimulation group was 0 mg (0-1), compared with 0 mg (0-3) for the sham group (p=0.524). Regarding the highest pain level experienced over the entire 8-day study period, only one participant (7%) who received active stimulation experienced severe pain, versus seven (47%) in those given sham (p=0.031). Conclusions: Percutaneous auricular neuromodulation reduced pain scores but not opioid requirements during the initial week after cholecystectomy and hernia repair. Given the ease of application as well as a lack of systemic side effects and reported complications, a definitive clinical trial appears warranted. Trial Registration Number: NCT05521516. Competing Interests: Competing interests: BMI, WBA, BA, JFS, ETS, BA, and JJF—the University of California San Diego has received funding and/or product from the following companies for other research studies of these authors: Epimed International (Dallas, Texas, USA), SPR Therapeutics (Cleveland, Ohio, USA), Infutronix (Natick, Massachusetts, USA), Avanos Medical (Irvine, California, USA), Masimo (Irvine, CA, USA), and Varian Medical Systems (Palo Alto, California, USA). Th remaining authors have no conflicts to disclose. (© American Society of Regional Anesthesia & Pain Medicine 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)
Databáze:	MEDLINE
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