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

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.

Study Overview

• Status: Completed
• Conditions: Total Laparoscopic Hysterectomy
• Intervention / Treatment: Drug: Tegileridine (tegileridine fumarate injection, IV); Drug: Oxycodone（Oxycodone Hydrochloride Injection，IV）

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Haikou, China
    • Department of Anesthesiology,the Second Affiliated Hospital of Hainan Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients undergoing laparoscopic total abdominal hysterectomy with single-lumen endotracheal tube placement under general anaesthesia.
2. Females aged 18-65 years with a BMI of 18-28 kg/m²;
3. Normal mouth opening and head/neck mobility;
4. Preoperative American Society of Anesthesiologists (ASA) physical status classification of I-III and Mallampati airway classification of I or II;
5. Patients must also be scheduled for postoperative analgesia and have signed an informed consent form.

Exclusion Criteria:

1. Patients with allergies to the medications used in this study.
2. Patients with severe diseases of major organs, such as the heart, lungs or brain, including a history of acute myocardial infarction, cerebral infarction, asthma or chronic obstructive pulmonary disease;
3. Patients with severe liver or kidney dysfunction, or concomitant severe endocrine disorders such as poorly controlled hypertension, diabetes, hyperthyroidism or hypothyroidism.
4. Patients with a difficult airway, oropharyngeal/cervical anomalies, or a history of prior tracheostomy;
5. A history of prolonged sedative/analgesic use, substance abuse or opioid dependence;
6. Patients with neuropsychiatric disorders or impaired communication/comprehension abilities.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tegileridine（T group）; Around 20 minutes before the end of the operation, patients in the T group were given 0.01 mg/kg of Tegileridine(dissolved in 10 ml of 0.9% sodium chloride injection solution. This was administered via continuous infusion at a rate of 60 ml/h).	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.
Experimental: Oxycodone（O group）; Around 20 minutes before the end of the operation, patients in the O group were given 0.06 mg/kg of Oxycodone(dissolved in 10 ml of 0.9% sodium chloride injection solution. This was administered via continuous infusion at a rate of 60 ml/h).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurrence of postoperative nausea and vomiting	Following surgery, a blinded evaluator assessed PONV using a 4-point ordinal scale (0 = none, 1 = nausea, 2 = retching, 3 = vomiting). Nausea was defined as a subjectively unpleasant sensation associated with awareness of the urge to vomit. Retching was defined as labored, spasmodic, rhythmic contraction of the respiratory muscles without expulsion of gastric contents. Vomiting was defined as the forceful expulsion of gastric contents from the mouth.	Within 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Richmond Agitation and Sedation Scale(RASS)	The research team assigns a RASS score (minimum -5 = unarousable, maximum +4 = combative; scores closer to 0 indicate an alert and calm state) by observing the patient immediately before tracheal extubation.	Immediately before removal of the endotracheal tube (Postoperative Day 0).
Success rate of postoperative pain management	Following extubation during anaesthesia recovery after surgery, pain intensity was assessed at rest using a 10-cm visual analogue scale (VAS) by a blinded evaluator (with a minimum score of 0 indicating no pain and a maximum score of 10 indicating the most severe pain imaginable). Analgesia was recorded as successful when the VAS score was ≤3; otherwise, it was considered unsuccessful.	After the surgery, before leaving the recovery room（Day 0）
Time of First Pressing of the PCIA	Time of First Postoperative Pressing of the Patient-Controlled Intravenous Analgesia（PCIA） pump	Within 48 hours after surgery
Overall incidence of adverse reactions	Incidence of Postoperative nausea and vomiting, hypotension, nasal congestion, dizziness, respiratory depression, delayed emergence from anesthesia, pruritus, muscle rigidity, convulsions, constipation, urinary retention, agitation during emergence, and convulsions.	Within 48 hours after surgery

Collaborators and Investigators

• Sponsor: Xin Chen
• Collaborators: Second Affiliated Hospital of Hainan Medical College

Publications and helpful links

General Publications

• Apfel CC, Kranke P, Katz MH, Goepfert C, Papenfuss T, Rauch S, Heineck R, Greim CA, Roewer N. Volatile anaesthetics may be the main cause of early but not delayed postoperative vomiting: a randomized controlled trial of factorial design. Br J Anaesth. 2002 May;88(5):659-68. doi: 10.1093/bja/88.5.659.
• Kissin I. Preemptive analgesia. Anesthesiology. 2000 Oct;93(4):1138-43. doi: 10.1097/00000542-200010000-00040. No abstract available.
• Yu W, Wu X, Liu L, Long B, Tian Y, Ma C, Dong Y. The Median Effective Dose of One Intravenous Bolus of Oxycodone for Postoperative Analgesia After Myomectomy and Hysterectomy With Local Ropivacaine Wound Infiltration: An Up-Down Dose-Finding Study. Anesth Analg. 2020 Nov;131(5):1599-1606. doi: 10.1213/ANE.0000000000005011.
• Wilder-Smith OH. Pre-emptive analgesia and surgical pain. Prog Brain Res. 2000;129:505-24. doi: 10.1016/S0079-6123(00)29037-7. No abstract available.
• Kalso E. Oxycodone. J Pain Symptom Manage. 2005 May;29(5 Suppl):S47-56. doi: 10.1016/j.jpainsymman.2005.01.010.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2025
• Primary Completion (Actual): January 13, 2026
• Study Completion (Actual): January 13, 2026

Study Registration Dates

• First Submitted: December 24, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative pain; Total Laparoscopic Hysterectomy; Oxycodone; Tegileridine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: HUMU2H-TCOPOP-CN-2025; No.823RC592 (Other Grant/Funding Number: Hainan Provincial Natural Science Foundation of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No