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

NCT07741188 | Not Yet Recruiting Phase 2

• 1 other identifier: Anrikefon LC01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

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.

Conditions

Gallbladder Stones; Gallbladder Polyps

Keywords

Laparoscopic Cholecystectomy; Anrikefon; Postoperative Pain Management; Opioid Analgesia

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery-15 (QoR-15) scale at 24 hours postoperatively.

  The QoR-15 scale was used 24 hours after surgery to assess the quality of patients' postoperative recovery. The total score of the QoR-15 scale ranges from 0 to 150, with higher scores indicating a better quality of postoperative recovery.

  24 hours after surgery

Secondary Outcomes (11)

• Resting and movement pain Numeric Rating Scale (NRS) Area Under the Curve (AUC 0-24h) after the initial dose

  24 hours after surgery

• Resting and movement (turning over) postoperative pain scores using the Numeric Rating Scale (NRS) at 0h, 2h, 8h, 16h, and 24h postoperatively.

  24 hours after surgery

• Rescue analgesic utilization: Cumulative consumption of rescue analgesia (meperidine 75 mg) at 0-12h and 0-24h after the first dose, number of rescue interventions, time to first rescue, and the percentage of subjects not requiring rescue analgesia.

  24 hours after surgery

• Incidence of shoulder discomfort, back pain, nausea, and vomiting in each group.

  24 hours after surgery

• Time to first oral intake, time to first flatus/defecation, and time to first ambulation.

  24 hours after surgery

Study Arms (2)

Anrikefon Group

EXPERIMENTAL

* 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 Group

ACTIVE COMPARATOR

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

Drug: Dezocine

Interventions

Anrikefon DRUG

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.

Anrikefon Group

Dezocine DRUG

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

Dezocine Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ Age ≤ 70 years, no gender restriction.
• American Society of Anesthesiologists (ASA) physical status classification I-II.
• kg/m² ≤ BMI ≤ 30 kg/m².
• Subjects undergoing elective LC under general anesthesia, with an estimated -surgical duration of ≤2 hours (including 1h).
• Voluntarily agree to participate in the study and sign the informed consent form (ICF).

You may not qualify if:

• History of allergy to nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, or intraoperative anesthetics specified in the protocol.
• 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 \[eGFR \<60 mL/min/1.73m²\]).
• Substance abuse: Current drug or alcohol dependency.
• Special populations: Pregnant or lactating women; any other conditions deemed unsuitable by the investigator.
• Acute severe cholecystitis attack within the past 7 days, or subjects in whom malignant gallbladder lesions cannot be ruled out.
• Presence of sleep disorders requiring pharmacological intervention; concomitant psychiatric disorders.

Sponsors & Collaborators

• Affiliated Hospital of Guangdong Medical University: lead

Study Sites (2)

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, 524001, China

Location

The Second Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, 524001, China

Location

MeSH Terms

Conditions

Cholecystolithiasis

Interventions

dezocine

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Central Study Contacts

Wei Dai, Ph.D., M.D.

CONTACT

+86 13828264321; dwgdmufy@gdmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)