Oliceridine compared with sufentanil in multimodal analgesia after renal transplantation: protocol for a single-centre, randomised, double-blind, positive-controlled trial.

introductionMost patients undergoing renal transplantation experience moderate to severe postoperative pain, which may induce physiological stress, exacerbate preexisting complications and impair functional recovery of the transplanted kidney. Although opioids are commonly used for postoperative analgesia, they are associated with various opioid-related adverse events (ORAEs). Oliceridine, a novel G protein-biased ligand μ-opioid receptor agonist, has been shown to provide effective analgesia while reducing the incidence of ORAEs without adversely affecting renal function. Therefore, oliceridine may represent a promising analgesic option for patients after renal transplantation, and clinical validation is warranted to evaluate its safety, efficacy and impact on immune function in these patients. METHODS AND ANALYSIS: This single-centre, randomised, double-blind, positive-controlled clinical trial is being conducted in China. A total of 212 renal transplant recipients requiring patient-controlled intravenous analgesia (PCIA) will be randomly assigned in a 1:1 ratio to receive either oliceridine or sufentanil for postoperative pain management. The oliceridine group will receive oliceridine at 0.3-0.6 mg/h, whereas those in the sufentanil group will receive sufentanil at 1-2 μg/h. Rescue analgesia will be provided if pain is inadequately controlled. The primary outcome is analgesic effective rate 24 hours after surgery. Secondary outcomes will include the (1) numerical rating scale (NRS) scores, cumulative AUC and maximum pain intensity at six time points within 48 hours postoperatively, time to first PCIA, number of effective PCIA presses and dosage of rescue analgesic within 48 hours; (2) occurrence of ORAEs within 48 hours; (3) dosage of antiemetic drugs within 48 hours; (4) satisfaction evaluation with analgesia at 48 hours; (5) renal function assessment at 1-7 days postoperatively, changes in inflammatory factors and postoperative immune indicators; and (6) recovery quality assessment at first day and third day postoperatively. ETHICS AND DISSEMINATION: Ethics approval was provided by the Ethics Committee of the First Affiliated Hospital of Xi'an Jiaotong University (XJTU1AF2024LSYY-348) prior to study commencement. Written informed consent will be obtained from all participants before enrolment. Results will be published in peer-reviewed journals and presented at academic conferences. TRIAL REGISTRATION NUMBER: ChiCTR2400091724 (chictr.org.cn).