Short-term clinical effectiveness of 5% lidocaine patch after arthroscopic rotator cuff repair: study protocol for a randomized, double-blinded, placebo-controlled clinical trial

BACKGROUND: Arthroscopic rotator cuff repair (ARCR) often causes unbearable postoperative pain, even more severe than before surgery. Opioids are the drugs of choice for temporary postoperative analgesia. However, this conventional approach also has some side effects and potential for drug abuse. The aims of this study are expected to verify the effect of 5% lidocaine patch (LP5) on the intensity of early postoperative pain, functional recovery and quality of life in patients undergoing ARCR. METHODS: In this randomized, double-blind, and placebo-controlled clinical trial, a total of 102 postoperative patients undergoing ARCR will be randomly assigned to either the LP5 group, receiving topical lidocaine analgesia, or the placebo control group. The primary outcome measure will be the change in the American Shoulder Elbow Surgeons score from pre-operation to 90 days post-operation. Secondary outcomes will include pain scores, range of motion, opioid use, safety indicators, blinding assessment and several shoulder function score questionnaires. The effect of the allocated treatment will be assessed at preoperative baseline and at 7-, 14-, 30- and 90-day postoperatively. DISCUSSION: In this study, the efficacy and safety of the 5% lidocaine patch will be evaluated in terms of short-term clinical symptoms in patients undergoing ARCR. The results of this study will help determine whether LP5 is effective in early functional recovery in ARCR and whether it relieves pain and reduces opioid consumption. TRIAL REGISTRATION: Chinese Clinical Trial Registry (http://www.chictr.org.cn) ChiCTR2200060108. Registered on 19 May 2022.