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A Study on the Efficacy and Safety of Anrikefon for Postoperative Pain Relief Following Laparoscopic Cholecystectomy

NCT07741188 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-08-03

No results posted yet for this study

Summary

This study is a multicenter, randomized, 1:1 parallel-group controlled clinical trial designed to evaluate the efficacy and safety of Anrikefon for postoperative analgesia in patients undergoing elective laparoscopic cholecystectomy (LC) under general anesthesia. Enrolled patients were randomly assigned to two groups (the Anrikefon group and the dizocine group) and received regular intravenous administration of the respective medication following the corresponding surgical procedure. The primary efficacy endpoint was the Quality of Recovery (QoR-15 score) at 24 hours postoperatively, combined with the Numerical Rating Scale (NRS), the Brief Pain Inventory (BPI), sleep quality (RCSQ), and postoperative recovery progress (time to first meal, first flatus, and first ambulation, etc.) for a comprehensive evaluation of efficacy; At the same time, safety indicators-including adverse events (such as nausea and vomiting, and shoulder and back pain), vital signs, and laboratory test results-were systematically monitored during the follow-up period to comprehensively evaluate the clinical utility of this protocol.

Conditions

  • Gallbladder Stones
  • Gallbladder Polyps

Interventions

DRUG

Anrikefon

1.0 µg/kg per dose, administered by intravenous bolus injection every 8 hours at 0, 8, and 16 hours postoperatively, for a total of 3 doses. Specific preparation: Dilute 1.0 µg/kg of Anrikefon with 0.9% sodium chloride injection to a total volume of 10 mL.

DRUG

Dezocine

5 mg/dose, IV bolus, q8h. Administered at 0h, 8h, and 16h postoperatively for a total of 3 doses.

Sponsors & Collaborators

  • Affiliated Hospital of Guangdong Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-09-30
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07741188 on ClinicalTrials.gov