NCT07326683

Clinical Study of Equivalent Doses of Oxycodone or Tegileridine on Patients Undergoing Gynecological Laparoscopic Hysterectomy

Effect of Equivalent Dose of Oxycodone or Tegileridine on Patients Undergoing Gynecological Laparoscopic Hysterectomy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Xin Chen · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This randomized, double-blind, controlled study aims to evaluate the efficacy and safety of Tegileridine or Oxycodone for postoperative analgesia in patients undergoing Total Laparoscopic Hysterectomy（TLH）. Subjects will be randomly assigned to receive an equivalent dose of intravenous Tegileridine or Oxycodone as part of a standard postoperative analgesia regimen. All patients will have access to rescue opioid analgesia according to the protocol. The primary outcome measures are the incidence of postoperative nausea and vomiting in two groups receiving a single dose of equivalent morphine analgesics (Group Tegileridine or Group Oxycodone).The secondary endpoints were designed to compare the success rate of postoperative analgesia, cumulative opioid consumption within 48 hours postoperatively, the time to first rescue analgesia, and the incidence of adverse events such as sedation, respiratory depression, pruritus, and constipation. Safety will be monitored throughout the study via predefined stop-and-report procedures. The study results will evaluate whether teglitazide provides a more effective, better-tolerated analgesic regimen for patients undergoing total laparoscopic hysterectomy.

Conditions

• Total Laparoscopic Hysterectomy

Interventions

Type	Name	Description
DRUG	Tegileridine (tegileridine fumarate injection, IV)	Tegileridine (tegileridine fumarate injection, IV) is a small-molecule μ-opioid receptor agonist with G-protein-biased signaling (relative to β-arrestin-2 recruitment), developed by Jiangsu Hengrui for postoperative analgesia. It is administered intravenously and was first approved in China in January 2024 for the treatment of moderate-to-severe pain after abdominal surgery; in this study, tegileridine is used as part of standardized multimodal analgesia according to protocol. In China it is regulated as a narcotic drug.
DRUG	Oxycodone（Oxycodone Hydrochloride Injection，IV）	Oxycodone bitartrate is a dual opioid receptor agonist that is used in clinical settings. Oxycodone bitartrate injection is indicated for the relief of moderate to severe cancer pain. It can be administered alone or in combination with non-steroidal anti-inflammatory drugs to provide acute combined analgesia. In January 2021, Jiangsu Enhua Pharmaceutical submitted a marketing authorisation application for Oxycodone bitartrate injection to the National Medical Products Administration.The application has been accepted and approved.

Timeline

• Start date: 2025-12-17
• Primary completion: 2026-01-13
• Completion: 2026-01-13
• First posted: 2026-01-08
• Last updated: 2026-04-17

Locations

1 site across 1 country: China