Efficacy of perioperative transcutaneous electrical acupoint stimulation on postoperative pain and recovery in patients undergoing pancreatectomy: a study protocol for a randomized controlled trial
摘要
Movement-evoked pain following pancreatectomy is often severe and inadequately controlled by conventional analgesic regimens. Transcutaneous electrical acupoint stimulation (TEAS), a non-invasive technique derived from acupuncture, has shown promise in reducing postoperative pain and opioid consumption. However, the efficacy of extended perioperative TEAS—particularly its sustained application through the early postoperative period—has not been evaluated in patients undergoing pancreatectomy.
MethodsThis will be a prospective, single-center, two-arm, randomised controlled trial. A total of 132 patients undergoing pancreatectomy will be randomised allocated to the TEAS and the Sham TEAS groups. The TEAS group will receive stimulation (5–30mA, the stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient, 2/100 Hz alternating, on the Neiguan (PC6), Zusanli (ST36), Hegu (LI4) and Waiguan (SJ5)) from 30 min before anesthesia for 30min and repeated on the first 1,2 and 3 days after surgery. The patients in the Sham TEAS group will receive electrodes applied, but will receive no stimulation. The primary outcome is the highest movement-evoked pain intensity during 72 h postoperatively, assessed by the numeric rating scale (NRS). The secondary outcomes include the highest movement-evoked pain at rest, morphine consumption, recovery quality, and sleep quality over 72 h postoperatively and levels of inflammatory factors. All statistical analyses will be performed based on the modified intention-to-treat principle.
DiscussionThis study aims to evaluate whether continuous TEAS during perioperative period (administered from 30 min before induction of anesthesia through 72 h postoperatively) will reduce the movement-evoked pain during postoperative 72 h in patients undergoing pancreatectomy. The findings may offer evidence for an effective opioid reducing anesthesia strategy that enhances analgesia and supports recovery, with potential value for broader clinical application.
Trial registrationClinicalTrials.gov, NCT06541561. Registered on 2 August 2024.