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Total Laparoscopic HysterectomyPhase 4NCT07326683

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

A Phase 4 study testing Tegileridine (tegileridine fumarate injection, IV) and Oxycodone（Oxycodone Hydrochloride Injection，IV） in people with Total Laparoscopic Hysterectomy, run by Xin Chen at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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）. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Total Laparoscopic Hysterectomy
What is being tested?
Tegileridine (tegileridine fumarate injection, IV) and Oxycodone（Oxycodone Hydrochloride Injection，IV）
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteChina
Study dates
17 Dec 2025to 13 Jan 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Haikou

Other trials in China

About this study

Official title: 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.

Being tested
Tegileridine (tegileridine fumarate injection, IV), Oxycodone（Oxycodone Hydrochloride Injection，IV）
Keywords
Tegileridine, Postoperative pain, Total Laparoscopic Hysterectomy, Oxycodone
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT07326683
Study groupRoleWhat they receive
Tegileridine（T group）ExperimentalAround 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).
Receives: Drug: Tegileridine (tegileridine fumarate injection, IV)
Oxycodone（O group）ExperimentalAround 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).
Receives: Drug: Oxycodone（Oxycodone Hydrochloride Injection，IV）

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 48 hours after surgery

Secondary outcomes (4)

  1. Time of First Pressing of the PCIA

    Time of First Postoperative Pressing of the Patient-Controlled Intravenous Analgesia（PCIA） pump

    Measured: Within 48 hours after surgery

  2. 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.

    Measured: Within 48 hours after surgery

  3. 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.

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

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2026
  2. Study start17 Dec 2025
  3. Primary completion13 Jan 2026
  4. Study completion13 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07326683
Sponsor's protocol ID
HUMU2H-TCOPOP-CN-2025
Other IDs
No.823RC592
Status last verified
Dec 2025
First submitted
24 Dec 2025
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 12067003

  • 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.

    PubMed 33079884

  • 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.

    PubMed 11098714

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

    PubMed 11020772

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

    PubMed 15907646

  • 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.

    PubMed 42199806

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tegileridine (tegileridine fumarate injection, IV) and Oxycodone（Oxycodone Hydrochloride Injection，IV） in people with Total Laparoscopic Hysterectomy, run by Xin Chen at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The occurrence of postoperative nausea and vomiting (time frame: Within 48 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07326683, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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