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

NCT07277153 | Completed Phase 4 DMC

• 2 other identifiers: HNMU2H-POPABD-CN-2025No.823RC592
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laparoscopic Surgery for Cholecystitis

Keywords

Tegileridine; Abdominal surgery; Postoperative pain; Moderate-to-severe pain

Outcome Measures

Primary Outcomes (1)

• Postoperative Visual Analog Scale(VAS)Pain Scores at Multiple Time Points

  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 Outcomes (3)

• Intraoperative opioid consumption

  Perioperative (induction of anesthesia to end of surgery).

• Quality of Recovery-15 (QoR-15) Score

  Day 1 and Day 2 postoperatively.

• Richmond Agitation and Sedation Scale(RASS)

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

Study Arms (3)

Pre-incision tegileridine (T1 group）

EXPERIMENTAL

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)

End-of-surgery tegileridine（T2 group）

EXPERIMENTAL

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)

Placebo Comparator（C group）

PLACEBO COMPARATOR

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

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.

End-of-surgery tegileridine（T2 group）; Pre-incision tegileridine (T1 group）

0.9% Normal Saline (0.9% Sodium Chloride) injection OTHER

0.9% sodium chloride (normal saline, IV) - matched 10 mL infusion over 10 minutes administered at the alternate timepoint to maintain blinding.

Placebo Comparator（C group）

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

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

Haikou, China

Location

Related Publications (6)

• Kuang Y, Shen L, Luo Y, Li B, Su X, Zhou Z, Zhao Y. Biased mu-opioid receptor agonists for postoperative pain: Balancing efficacy and safety in clinical translation. Pharmacol Res. 2025 Nov;221:107994. doi: 10.1016/j.phrs.2025.107994. Epub 2025 Oct 12. No abstract available.

  PMID: 41086976 RESULT

• Huang L, Jiang H, Huang Y, Li J. Exploring Pharmacokinetic interactions between SHR8554, a micro-opioid receptor biased agonist, and Itraconazole in healthy Chinese subjects. Sci Rep. 2025 Jul 2;15(1):22635. doi: 10.1038/s41598-025-98697-3.

  PMID: 40593123 RESULT

• Feng Y, Yang G, Zhang P, Li L, Tian J, Wang Y, Chu Q. The Analgesic Effect of Tegileridine in Older Adult Patients After Laparoscopic Abdominal Tumor Surgery: Study Protocol for a Randomized Controlled Trial. Pain Ther. 2026 Feb;15(1):433-441. doi: 10.1007/s40122-025-00798-4. Epub 2025 Nov 20.

  PMID: 41264221 RESULT

• Dhillon S. Correction: Tegileridine: First Approval. Drugs. 2024 Aug;84(8):1011. doi: 10.1007/s40265-024-02079-4. Epub 2024 Aug 12. No abstract available.

  PMID: 39133436 RESULT

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

  PMID: 11020772 RESULT

• Zhao Y, Lu Z, Song X, Xie H, Xiao X, Wang G, Zhou Q, Zhang Q, Liu L, Lan Z, Bai N, Wang H, Pan Z, Dong L, Lin X, Chen G, Wang Q, Dong J, Deng J, Nan Y, Zhang J, Zhou X, Huang Y, Chen Y, He H, Yang Y, Yao D, Jia J, Jin S, Zhang Y, Luo Z, Li J, Zhang L, Wang F, Jing J, Zhu J, Li L, Wang G, Guo H, Wang Q, Su D, Yu W, Gu X. Efficacy and safety of SHR8554 on postoperative pain in subjects with moderate to severe acute pain following orthopedic surgery: A multicenter, randomized, double-blind, dose-explored, active-controlled, phase II/III clinical trial. Pharmacol Res. 2025 Feb;212:107576. doi: 10.1016/j.phrs.2025.107576. Epub 2025 Jan 3.

  PMID: 39755132 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Saline Solution; Sodium Chloride; Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

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: November 27, 2025
• First Posted: December 11, 2025
• Study Start: November 30, 2025
• Primary Completion: March 25, 2026
• Study Completion: March 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)