Clinical Study on the Effect of Tegileridine on Postoperative Pain in Patients Undergoing Abdominal Surgery.
NCT ID: NCT07277153
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
150 participants
INTERVENTIONAL
2025-10-18
2025-12-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
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（C group）
0.9% sodium chloride (normal saline, IV) - matched 10 mL infusion over 10 minutes administered at the alternate timepoint to maintain blinding.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
65 Years
ALL
No
Sponsors
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The Second Affiliated Hospital of Hainan Medical University
OTHER
Xin Chen
OTHER
Responsible Party
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Xin Chen
Associate Researcher,the Second Affiliated Hospital of Hainan Medical University
Locations
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Department of Anesthesiology,the Second Affiliated Hospital of Hainan Medical University
Haikou, , China
Countries
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References
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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.
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.
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. 2025 Nov 20. doi: 10.1007/s40122-025-00798-4. Online ahead of print.
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.
Kissin I. Preemptive analgesia. Anesthesiology. 2000 Oct;93(4):1138-43. doi: 10.1097/00000542-200010000-00040. No abstract available.
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.
Other Identifiers
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No.823RC592
Identifier Type: OTHER
Identifier Source: secondary_id
HNMU2H-POPABD-CN-2025
Identifier Type: -
Identifier Source: org_study_id