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| ID | Type | Description | Link |
|---|---|---|---|
| No.823RC592 | Other Grant/Funding Number | Hainan Provincial Natural Science Foundation of China |
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| Name | Class |
|---|---|
| Second Affiliated Hospital of Hainan Medical College | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology,the Second Affiliated Hospital of Hainan Medical University | Haikou | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12067003 | Result | 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. | |
| 33079884 | Result |
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| 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. |
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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 |
| 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） |
| 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. |
| 11098714 | 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. |
| 11020772 | Result | Kissin I. Preemptive analgesia. Anesthesiology. 2000 Oct;93(4):1138-43. doi: 10.1097/00000542-200010000-00040. No abstract available. |
| 15907646 | Result | Kalso E. Oxycodone. J Pain Symptom Manage. 2005 May;29(5 Suppl):S47-56. doi: 10.1016/j.jpainsymman.2005.01.010. |
| 42199806 | Derived | Fu Y, Chen X, Gao FP, Liang Y, Wang DY, Chen CQ, Sun H. Tegileridine, a Biased mu-Opioid Receptor Agonist, versus Oxycodone for Postoperative Analgesia and Postoperative Nausea and Vomiting After Total Laparoscopic Hysterectomy: A Randomized, Double-Blind, Single-Center, Controlled Trial. Drug Des Devel Ther. 2026 May 21;20:598457. doi: 10.2147/DDDT.S598457. eCollection 2026. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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