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

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated June 1, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary endpoint(s) modifiedv3
  2. Notable Start date: Nov 11, 2024 to Jun 1, 2025v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06990893
Lead Sponsor Anqing Municipal Hospital
Conditions
(from sponsor)
Sufentanil, Morphine, Validity, Safety, Oliceridine
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov