Clinical Study on the Effect of Tegileridine on Postoperative Pain in Patients Undergoing Abdominal Surgery.

April 9, 2026 updated by: Xin Chen

Clinical Study on the Effect of Tegileridine on Postoperative Pain in PatientsUndergoing Abdominal Surgery：A Randomized Controlled Double-blind Trial.

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of tegileridine fumarate injection for postoperative analgesia in adults experiencing moderate-to-severe pain after abdominal surgery. Participants will be randomized to receive intravenous tegileridine or matching placebo as part of a standardized multimodal analgesia protocol; all patients will have access to rescue opioid analgesia per institutional practice. The primary objective is to determine whether tegileridine improves postoperative pain control during the first 24-48 hours after surgery. Secondary objectives include comparing cumulative opioid consumption, time to first rescue analgesia, patient-reported satisfaction with pain control, recovery milestones (e.g., time to ambulation), and the incidence of adverse events such as nausea, vomiting, sedation, respiratory depression, pruritus, and constipation. Safety will be monitored throughout the study with predefined stopping and reporting procedures. The results aim to inform whether tegileridine can provide effective and well-tolerated analgesia for patients with moderate-to-severe postoperative pain following abdominal procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults 18-65 years; BMI 18-35 kg/m²; ASA physical status I-III.

    • Diagnosed with symptomatic gallbladder stone disease and scheduled for elective laparoscopic cholecystectomy under general anesthesia; expected procedure duration ≥60 minutes and postoperative hospitalization ≥24 hours.

      • Investigator expects moderate-to-severe postoperative pain; willing to receive standardized multimodal analgesia and protocolized rescue analgesia.

        • Able to understand pain scales (NRS/VAS) and provide written informed consent.

          • Women of childbearing potential: negative pregnancy test within 72 hours preoperatively and agreement to use effective contraception through 30 days after last dose.

Exclusion Criteria:

  • Known hypersensitivity to opioids or any component of the study drug.

    • Chronic opioid use/tolerance (e.g., ≥30 mg MME/day for ≥7 consecutive days within 30 days pre-op) or current methadone/buprenorphine therapy.

      • Planned/required neuraxial analgesia (epidural/spinal), continuous peripheral nerve blocks, or use of long-acting local anesthetic formulations that would confound postoperative pain assessment; brief intraoperative wound infiltration with short-acting local anesthetics is allowed if standardized.

        • Significant respiratory disease (e.g., uncontrolled obstructive sleep apnea, GOLD III-IV COPD) or anticipated postoperative mechanical ventilation >24 hours.

          ⑤Severe hepatic or renal impairment (Child-Pugh B/C; eGFR <30 mL/min/1.73 m²; or ALT/AST >3×ULN with total bilirubin >2×ULN).

          ⑥Clinically unstable cardiovascular or cerebrovascular disease (e.g., shock, uncontrolled arrhythmias, myocardial infarction or stroke within 6 months), or persistent SBP <90 mmHg.

          ⑦Concomitant medications that cannot be safely withheld: MAO inhibitors within 14 days; strong CNS depressants requiring continued use (e.g., benzodiazepines/barbiturates); mixed agonist-antagonist opioids (e.g., nalbuphine, buprenorphine) within 7 days.

          ⑧Severe psychiatric/neurologic disease or communication/cognitive impairment precluding valid pain scoring or follow-up.

          ⑨Pregnancy or breastfeeding; unwillingnebass to use contraception.

          ⑩Substance abuse (alcohol or drugs) within 12 months.

          ⑪Participation in another interventional study with study drug/device within 30 days.

          ⑫Any other condition that, in the opinion of the investigator, makes participation unsafe or impractical (e.g., severe active infection, planned ICU admission).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pre-incision tegileridine (T1 group）

Tegileridine 1 mg IV, diluted to 10 mL in 0.9% sodium chloride, infused over 10 minutes after anesthesia induction and before skin incision.

At skin closure, a matched 10 mL normal saline infusion is given. Rescue analgesia is permitted per institutional practice.
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: End-of-surgery tegileridine（T2 group）

After anesthesia induction and before skin incision, a matched 10 mL normal saline infusion is given.

At skin closure, tegileridine 1 mg IV, diluted to 10 mL in 0.9% sodium chloride, is infused over 10 minutes. Rescue analgesia is permitted per institutional practice.
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.
Placebo Comparator: Placebo Comparator（C group）
0.9% sodium chloride (normal saline, IV) - matched 10 mL infusion over 10 minutes administered at the alternate timepoint to maintain blinding.
Other: 0.9% Normal Saline (0.9% Sodium Chloride) injection
0.9% sodium chloride (normal saline, IV) - matched 10 mL infusion over 10 minutes administered at the alternate timepoint to maintain blinding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Visual Analog Scale(VAS)Pain Scores at Multiple Time Points
Time Frame: 2 hours ( h), 6 h, 12 h, 24 h, 36 h and 48 h after surgery
Pain intensity is assessed with the 10-cm Visual Analog Scale (minimum 0 = no pain, maximum 10 = worst imaginable pain) at rest by blinded assessors at 2 h, 6 h, 12 h, 24 h, 36 h and 48 h after surgery; lower scores indicate less pain. When rescue analgesia is required, VAS is recorded immediately before rescue dosing.
2 hours ( h), 6 h, 12 h, 24 h, 36 h and 48 h after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative opioid consumption
Time Frame: Perioperative (induction of anesthesia to end of surgery).
Total intraoperative opioid use, expressed in intravenous morphine milligram equivalents.
Perioperative (induction of anesthesia to end of surgery).
Quality of Recovery-15 (QoR-15) Score
Time Frame: Day 1 and Day 2 postoperatively.
Researchers assist patients in completing the QoR-15 questionnaire (minimum 0 = very poor quality of recovery, maximum 150 = excellent quality of recovery); higher scores indicate better quality of recovery.
Day 1 and Day 2 postoperatively.
Richmond Agitation and Sedation Scale(RASS)
Time Frame: Immediately before removal of the endotracheal tube (Postoperative Day 0).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xin Chen

Collaborators

The Second Affiliated Hospital of Hainan Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2025

Primary Completion (Actual)

March 25, 2026

Study Completion (Actual)

March 30, 2026

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HNMU2H-POPABD-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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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