Laparoscopic Surgery for CholecystitisPhase 4NCT07277153
Clinical Study on the Effect of Tegileridine on Postoperative Pain in Patients Undergoing Abdominal Surgery.
A Phase 4 study testing Tegileridine (tegileridine fumarate injection, IV) and 0.9% Normal Saline (0.9% Sodium Chloride) injection in people with Laparoscopic Surgery for Cholecystitis, run by Xin Chen at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Surgery for Cholecystitis
- What is being tested?
- Tegileridine (tegileridine fumarate injection, IV) and 0.9% Normal Saline (0.9% Sodium Chloride) injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2025to 30 Mar 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology,the Second Affiliated Hospital of Hainan Medical University
Haikou
About this study
Official title: 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.
- Conditions
- Laparoscopic Surgery for Cholecystitis
- Being tested
- Tegileridine (tegileridine fumarate injection, IV), 0.9% Normal Saline (0.9% Sodium Chloride) injection
- Keywords
- Tegileridine, Abdominal surgery, Postoperative pain, Moderate-to-severe pain
- 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.
0.9% Normal Saline (0.9% Sodium Chloride) injectionOther
0.9% sodium chloride (normal saline, IV) - matched 10 mL infusion over 10 minutes administered at the alternate timepoint to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: 0.9% Normal Saline (0.9% Sodium Chloride) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours ( h), 6 h, 12 h, 24 h, 36 h and 48 h after surgery
Secondary outcomes (3)
Intraoperative opioid consumption
Total intraoperative opioid use, expressed in intravenous morphine milligram equivalents.
Measured: Perioperative (induction of anesthesia to end of surgery).
Quality of Recovery-15 (QoR-15) Score
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.
Measured: Day 1 and Day 2 postoperatively.
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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start30 Nov 2025
- Primary completion25 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Surgery for CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xin Chen
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Hainan Medical University
- Responsible party
- Sponsor-investigator, Xin Chen, Hainan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277153
- Sponsor's protocol ID
- HNMU2H-POPABD-CN-2025
- Other IDs
- No.823RC592
- Status last verified
- Apr 2026
- First submitted
- 27 Nov 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41086976Huang 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.
PubMed 40593123Feng 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.
PubMed 41264221Dhillon 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.
PubMed 39133436Kissin I. Preemptive analgesia. Anesthesiology. 2000 Oct;93(4):1138-43. doi: 10.1097/00000542-200010000-00040. No abstract available.
PubMed 11020772Zhao 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.
PubMed 39755132
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effect of Tegileridine on Postoperative Pain in PatientsUndergoing Abdominal Surgery：A Randomized Controlled Double-blind Trial.
- ClinicalTrials.gov ID
- NCT07277153
- Acronym / sponsor ID
- HNMU2H-POPABD-CN-2025
- Conditions
- Laparoscopic Surgery for Cholecystitis
- Keywords
- Tegileridine, Abdominal surgery, Postoperative pain, Moderate-to-severe pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Xin ChenUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Hainan Medical University
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-incision tegileridine (T1 group） | Experimental | Drug: Tegileridine (tegileridine fumarate injection, IV)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. |
| End-of-surgery tegileridine（T2 group） | Experimental | Drug: Tegileridine (tegileridine fumarate injection, IV)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. |
| Placebo Comparator（C group） | Placebo comparator | Other: 0.9% Normal Saline (0.9% Sodium Chloride) injection0.9% sodium chloride (normal saline, IV) - matched 10 mL infusion over 10 minutes administered at the alternate timepoint to maintain blinding. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults 18-65 years; BMI 18-35 kg/m²; ASA physical status I-III.
Key exclusion criteria (12 listed)
- Known hypersensitivity to opioids or any component of the study drug.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | End-of-surgery tegileridine（T2 group）, Pre-incision tegileridine (T1 group） |
| 0.9% Normal Saline (0.9% Sodium Chloride) injection0.9% sodium chloride (normal saline, IV) - matched 10 mL infusion over 10 minutes administered at the alternate timepoint to maintain blinding. | Other | Placebo Comparator（C group） |
Primary outcome
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.
3 secondary outcomes
Intraoperative opioid consumption
Time frame: Perioperative (induction of anesthesia to end of surgery).
Quality of Recovery-15 (QoR-15) Score
Time frame: Day 1 and Day 2 postoperatively.
Richmond Agitation and Sedation Scale(RASS)
Time frame: Immediately before removal of the endotracheal tube (Postoperative Day 0).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Results publication: PubMed 41086976Kuang 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.
- Results publication: PubMed 40593123Huang 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.
- Results publication: PubMed 41264221Feng 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.
- Results publication: PubMed 39133436Dhillon 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.
- Results publication: PubMed 11020772Kissin I. Preemptive analgesia. Anesthesiology. 2000 Oct;93(4):1138-43. doi: 10.1097/00000542-200010000-00040. No abstract available.
- Results publication: PubMed 39755132Zhao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tegileridine (tegileridine fumarate injection, IV) and 0.9% Normal Saline (0.9% Sodium Chloride) injection in people with Laparoscopic Surgery for Cholecystitis, 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 12 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 13 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. Some participants in this study may receive a placebo. 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?
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). 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 NCT07277153, 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 13 Apr 2026.