A Study on the Efficacy and Safety of Anrikefon for Postoperative Pain Relief Following Laparoscopic Cholecystectomy | NCT07741188

NCT07741188

Overview

NCT ID: NCT07741188
Lead Sponsor: Affiliated Hospital of Guangdong Medical UniversityOTHER
Official Title: A Multicenter, Randomized, Parallel-Group Controlled Study Evaluating the Efficacy and Safety of Anrikefon in Postoperative Pain Management in Patients Undergoing Elective Laparoscopic Cholecystectomy Under General Anesthesia
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Sep 30, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

1.18 ≤ Age ≤ 70 years, no gender restriction.

2.American Society of Anesthesiologists (ASA) physical status classification I-II.

3.18 kg/m² ≤ BMI ≤ 30 kg/m².

4.Subjects undergoing elective LC under general anesthesia, with an estimated -surgical duration of ≤2 hours (including 1h).

5.Voluntarily agree to participate in the study and sign the informed consent form (ICF).

Exclusion Criteria:

1.History of allergy to nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, or intraoperative anesthetics specified in the protocol.

2.Severe systemic diseases that, in the investigator's judgment, may significantly increase surgical risk or interfere with pain assessment (e.g., uncontrolled hypertension [SBP ≥170 mmHg and/or DBP ≥105 mmHg], uncontrolled hyperglycemia [fasting blood glucose ≥11.1 mmol/L], recent severe respiratory tract infection, severe gastritis, gastric/duodenal ulcers, upper abdominal surgery within 3 months, severe hepatic impairment [Child-Pugh score >9], chronic kidney disease [eGFR <60 mL/min/1.73m²]).

3.Substance abuse: Current drug or alcohol dependency.

4.Special populations: Pregnant or lactating women; any other conditions deemed unsuitable by the investigator.

5.Acute severe cholecystitis attack within the past 7 days, or subjects in whom malignant gallbladder lesions cannot be ruled out.

6.Presence of sleep disorders requiring pharmacological intervention; concomitant psychiatric disorders.

Study Plan

Study Type: Interventional
Phase: Phase 2
Enrollment: 144Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Wei Dai, Ph.D., M.D.Contact
dwgdmufy@gdmu.edu.cn+86 13828264321

Similar Studies

Participant Group/Arms

Anrikefon GroupExperimental

* Subjects will undergo screening according to the trial flowchart. Successfully screened subjects will obtain a randomization number prior to administration and will be divided into two groups: the Anrikefon group and the Dezocine group. * Anrikefon Group: 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: Anrikefon

Dezocine GroupActive Comparator

Drug: Dezocine