Laparoscopic Surgery for Cholecystitis
Conditions
Keywords
Tegileridine, Abdominal surgery, Postoperative pain, Moderate-to-severe pain
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.
Interventions
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% sodium chloride (normal saline, IV) - matched 10 mL infusion over 10 minutes administered at the alternate timepoint to maintain blinding.
Sponsors
Xin Chen
The Second Affiliated Hospital of Hainan Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Visual Analog Scale(VAS)Pain Scores at Multiple Time Points | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative opioid consumption | Perioperative (induction of anesthesia to end of surgery). | Total intraoperative opioid use, expressed in intravenous morphine milligram equivalents. |
| Quality of Recovery-15 (QoR-15) Score | 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. |
| Richmond Agitation and Sedation Scale(RASS) | 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. |
Countries
China
Outcome results
None listed