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Percutaneous auricular neuromodulation (nerve stimulation) for the treatment of pain following cholecystectomy and hernia repair: a randomized, double-masked, sham-controlled pilot study.
- Source :
-
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. - Publication Year :
- 2024
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Abstract
- 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.<br />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.<br />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).<br />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.<br />Trial Registration Number: NCT05521516.<br />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.<br /> (© American Society of Regional Anesthesia & Pain Medicine 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)
- Subjects :
- Humans
Pilot Projects
Double-Blind Method
Male
Female
Middle Aged
Adult
Aged
Analgesics, Opioid administration & dosage
Analgesics, Opioid therapeutic use
Pain Measurement methods
Treatment Outcome
Feasibility Studies
Pain, Postoperative diagnosis
Pain, Postoperative etiology
Pain, Postoperative therapy
Pain, Postoperative prevention & control
Herniorrhaphy adverse effects
Transcutaneous Electric Nerve Stimulation methods
Cholecystectomy adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1532-8651
- Volume :
- 49
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Regional anesthesia and pain medicine
- Publication Type :
- Academic Journal
- Accession number :
- 38388014
- Full Text :
- https://doi.org/10.1136/rapm-2024-105283