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

NCT07326683 | Completed Phase 4 DMC

• 2 other identifiers: HUMU2H-TCOPOP-CN-2025No.823RC592
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tegileridine; Postoperative pain; Total Laparoscopic Hysterectomy; Oxycodone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time of First Pressing of the PCIA

  Within 48 hours after surgery

• Overall incidence of adverse reactions

  Within 48 hours after surgery

• Richmond Agitation and Sedation Scale(RASS)

  Immediately before removal of the endotracheal tube (Postoperative Day 0).

• Success rate of postoperative pain management

  After the surgery, before leaving the recovery room（Day 0）

Study Arms (2)

Tegileridine（T group）

EXPERIMENTAL

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)

Oxycodone（O group）

EXPERIMENTAL

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）

Interventions

Tegileridine (tegileridine fumarate injection, IV) DRUG

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.

Tegileridine（T group）

Oxycodone（Oxycodone Hydrochloride Injection，IV） DRUG

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.

Oxycodone（O group）

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with allergies to the medications used in this study.
• 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;
• Patients with severe liver or kidney dysfunction, or concomitant severe endocrine disorders such as poorly controlled hypertension, diabetes, hyperthyroidism or hypothyroidism.
• Patients with a difficult airway, oropharyngeal/cervical anomalies, or a history of prior tracheostomy;
• A history of prolonged sedative/analgesic use, substance abuse or opioid dependence;
• Patients with neuropsychiatric disorders or impaired communication/comprehension abilities.

Sponsors & Collaborators

• Xin Chen: lead
• Second Affiliated Hospital of Hainan Medical College: collaborator

Study Sites (1)

Department of Anesthesiology,the Second Affiliated Hospital of Hainan Medical University

Haikou, China

Location

Related Publications (5)

• 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.

  PMID: 12067003 RESULT

• 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.

  PMID: 33079884 RESULT

• 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.

  PMID: 11098714 RESULT

• Kissin I. Preemptive analgesia. Anesthesiology. 2000 Oct;93(4):1138-43. doi: 10.1097/00000542-200010000-00040. No abstract available.

  PMID: 11020772 RESULT

• Kalso E. Oxycodone. J Pain Symptom Manage. 2005 May;29(5 Suppl):S47-56. doi: 10.1016/j.jpainsymman.2005.01.010.

  PMID: 15907646 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Researcher,the Second Affiliated Hospital of Hainan Medical University

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 8, 2026
• Study Start: December 17, 2025
• Primary Completion: January 13, 2026
• Study Completion: January 13, 2026
• Last Updated: April 17, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)