Postoperative analgesic effect of acupotomy combined with patient-controlled analgesia in patients undergoing video-assisted thoracoscopic surgery: a study protocol for a randomized controlled trial

BACKGROUND: Postoperative acute pain is a common issue following thoracic surgery. Acupotomy is a common and safe intervention method for pain treatment in clinical practice. In previous preliminary experiments, we found that acupotomy has a good clinical effect and good safety in the treatment of pain after thoracoscopic surgery. However, due to a lack of a rigorous design and an adequate sample size, its efficacy still requires further confirmation. The purpose of this study will be to explore the efficacy and safety of acupotomy combined with patient-controlled analgesia (PCA) for the treatment of pain after video-assisted thoracic surgery (VATS). METHODS: The study will be a single-centre, parallel group, randomized controlled trial. Seventy patients with significant pain after thoracoscopic surgery with a visual analogue scale (VAS) score ≥ 7 will be included and randomly distributed into two groups: G1, the acupotomy combined with PCA group; and G2, the conventional PCA group. The primary outcome measure is pain scores at rest and coughing evaluated with the VAS by a blinded observer in the postanaesthesia care unit (PACU) and postoperatively at 1, 2, 4, 8, 12, 24, 48, and 72 h. The secondary outcome measures are postoperative requirements for rescue analgesia, the cumulative amount of self-administered analgesics, the level of sedation (LOS), the Bruggemann comfort scale (BCS), and the functional activity score (FAS) concerning adverse effects and patient satisfaction. DISCUSSION: This trial has the potential to identify an innovative and effective analgesic method for postoperative pain management for VATS. The findings may advocate for the inclusion of the treatment of comorbid pain after thoracoscopy in current pain management practice guidelines. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900027191. Registered on 4 November 2019