Effect of Electroacupuncture Intervention on Postoperative Pain in Patients Receiving Shoulder Arthroscopic Surgery: Study Protocol for A Non-inferiority Randomized Controlled Trial

Abstract

Purpose: Shoulder arthroscopy , as a minimally invasive surgical technique for patients who have shoulder injuries, has the advantages of short inpatient period and fast postoperative recovery. However, Patients experienced surgery have a common symptoms : postoperative pain . Which can delay rehabilitation and influence the result of treatment . Although there are many managements for pain after shoulder arthroscopy surgery, the adherence rate of interventions remains low, and adverse effects often occur. Electroacupuncture is a traditional Chinese medicine treatment which is used to alleviate pain after surgery by inhibiting the functional connection between cerebellum and cortex thalamus in a large number of clinical studies. Therefore, this study aims to explore the effect of electroacupuncture on postoperative pain in patients receiving shoulder arthroscopic. Methods and Analysis: This is a single-center, non-inferiority, randomized, single-blind, placebo-controlled trial. This trial aims to evaluate the efficacy and safety of electroacupuncture for analgesia in patients receiving arthroscopic shoulder surgery. 120 patients receiving rotator cuff repair under shoulder arthroscopy will be recruited. They will be randomly divided into an acupuncture analgesia group (patients receive electroacupuncture analgesia and intravenous patient controlled analgesia with 0.9% saline after surgery) and an intravenous analgesia group (patients receive sham electroacupuncture and intravenous patient controlled analgesia with analgesic drugs). The main outcome is postoperative pain score. The secondary outcomes are the patients’ postoperative analgesic requirements, levels of inflammatory factors before and after acupuncture, patient satisfaction, postoperative complications, incidence of delirium, sleep quality, and shoulder joint function rehabilitation. Discussion: This study will be the first time to explore the effect and safety of electroacupuncture on postoperative shoulder pain as a clinical trial. Our finding will provide a new insight to alleviate pain after shoulder surgery. Trial registration: This research was registered at the China Clinical Trials Registry. The registration number is ChiCTR2300068773.