Efficacy of tegileridine combined with intercostal nerve block for postoperative analgesia following thoracoscopic pulmonary resection: a study protocol for a randomised controlled trial.

Abstract

Patients undergoing thoracoscopic pulmonary resection are prone to moderate-to-severe acute postoperative pain, which not only increases the risk of pulmonary complications but may also lead to chronic postsurgical pain. While traditional opioids provide effective analgesia, they are associated with significant adverse effects. Intercostal nerve block (ICNB) can precisely relieve incisional pain but has a limited duration of action. Tegileridine is a novel biased μ-opioid receptor agonist, offering favourable analgesic efficacy with fewer adverse reactions. Currently, there is a lack of research on the combination of tegileridine and ICNB for analgesia following thoracoscopic pulmonary resection, warranting further clinical exploration. This single-centre, randomised, double-blind, non-inferiority trial is designed to compare the postoperative analgesic efficacy of tegileridine-based patient-controlled intravenous analgesia (PCIA) combined with ICNB versus sufentanil-based PCIA combined with ICNB in patients undergoing thoracoscopic pulmonary resection. A total of 118 participants are enrolled and randomly assigned in a 1:1 ratio to either the tegileridine group or the sufentanil group. The primary outcome is the pain Visual Analogue Scale score during movement within 48 hours postoperatively, with non-inferiority determined using a margin of -1 point and 95% CIs. Secondary outcomes include the number of rescue analgesic interventions, PCIA-related parameters (total analgesic consumption, number of effective presses and total number of presses), incidence of opioid-related adverse events (respiratory depression, postoperative nausea and vomiting) and overall patient satisfaction. The trial protocol was approved by the Medical Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology on 14 February 2026 (Approval No. 2026-S010). The findings will be disseminated through publication in a peer-reviewed journal and on relevant institutional websites. NCT07386626.