Clinical Trial

Comparison of the Analgesic Effect of Oliceridine Versus Morphine or Sufentanil for Postoperative Analgesia in Lumbar Surgeries: a Randomized Control Trial

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Summary
Objective: This study aimed to compare the efficacy and safety of oliceridine versus morphine and sufentanil for postoperative analgesia following elective lumbar spine surgery. Methods: In this randomized, controlled trial, 90 patients scheduled for lumbar spine surgery were allocated in a 1:1:1 ratio to receive postoperative intravenous patient-controlled analgesia (PCIA) with either oliceridine (Group O,1.5mg oliceridine for loading dose, 0.5mg/kg oliceridine for PICA), morphine (Group M,4mg morphine for loading dose,1.5mg/kg morphine for PICA), or sufentanil (Group S,4ug sufentanil for loading dose,1.5ug/kg sufentanil for PICA). The primary outcome was the movement Visual Analogue Scale (VAS) score at 6 hours postoperatively. Secondary outcomes included resting and movement VAS scores, ramsay sation score at 0.5, 2, 6, 12, 24, and 48 hours postoperatively (excluding the motor VAS score at 6 hours postoperatively); number of PCIA demands and rescue analgesic requirements within 48 hours; hemodynamic parameters at 5, 10, 15, 30, and 60 minutes after administration of the initial loading dose. The incidence of adverse events within 48 hours postoperatively, such as nausea and vomiting, somnolence, respiratory depression, or pruritus.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-06-02
Trial Details
NCT Number NCT06990893
Lead Sponsor Anqing Municipal Hospital
Conditions Sufentanil, Morphine, Validity, Safety, Oliceridine
Enrollment 90 participants
Start Date 2025-06-01
Primary Completion 2026-10-01 (estimated)
Study Completion 2026-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-01