Efficacy and Safety of Anrikefon Injection for Multimodal Postoperative Analgesia in Patients Undergoing Laparoscopic Hepatectomy

Efficacy and Safety of Anrikefon Injection for Multimodal Postoperative Analgesia in Patients Undergoing Laparoscopic Hepatectomy:A Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial

A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Acute Pain
• Intervention / Treatment: Drug: Anruikefon 1 μg/kg per dose Group; Drug: Anruikefon 100 μg per dose Group; Drug: Control group

Detailed Description

A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.

• Study Type: Interventional
• Enrollment (Estimated): 117
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Changzhen Shang; Phone Number: +86-20-3407 0701; Email: shchzh2@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
      • Contact: Changzhen Shang; Phone Number: +86-20-3407 0701; Email: shchzh2@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged ≥ 18 years;
• American Society of Anesthesiologists (ASA) physical status classification I-III;
• Body mass index (BMI): 18 kg/m² ≤ BMI ≤ 30 kg/m²;
• Patients scheduled to undergo laparoscopic hepatectomy under general anesthesia with estimated operation duration ≤ 5 hours;
• Agree to participate in this trial and voluntarily sign the informed consent form.

Exclusion Criteria:

• Patients with a history of severe cardiopulmonary disease, neuropsychiatric disorders, digestive system diseases, chronic dizziness or vestibular dysfunction;
• Patients undergoing emergency surgery or trauma patients;
• Intraoperative conversion to open laparotomy;
• History of abdominal surgery within the past 3 months;
• Patients undergoing liver transplantation or with metastasis to other organs;
• Patients requiring synchronous resection of organs other than the gallbladder, extrahepatic bile ducts and intestines due to intraoperative clinical needs;
• Severe renal dysfunction (estimated glomerular filtration rate <30 mL/min/1.73 m²);
• Laboratory findings or clinical evaluation indicating hypothyroidism or hypokalemia graded ≥ Grade 3 per CTCAE v6.0;
• Subjects who experienced nausea, retching or vomiting within 24 hours before anesthesia induction (excluding those caused by bowel preparation);
• Patients expected to require postoperative mechanical ventilation via endotracheal intubation or naso/orogastric tube placement for more than 24 hours;
• Known allergy or contraindication to opioids and other anesthetics, antiemetics that may be administered during the trial.
• Use of drugs with analgesic, antiemetic or anti-inflammatory effects with unknown half-life within 14 days prior to randomization; or the interval between the last administration and randomization is shorter than 5 half-lives or the duration of drug effect (whichever is longer). Such drugs include, but are not limited to, opioid analgesics, non-opioid analgesics, antiemetics (or drugs with antiemetic properties), sedative-hypnotics, sedative anesthetics, glucocorticoids and other drugs with analgesic or antiemetic effects.
• Subjects with any other factors deemed by the investigator(s) to render them unsuitable for participation in this clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anruikefon 1 μg/kg per dose Group; Anruikefon 1 μg/kg per dose, once every 8 hours (q8h), for a total of 6 doses.	Drug: Anruikefon 1 μg/kg per dose Group; Anruikefon 1 μg/kg/dose, once every 8 hours (q8h), for a total of 6 doses.
Experimental: Anruikefon 100 μg per dose Group; Anruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses.	Drug: Anruikefon 100 μg per dose Group; Anruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses.
Placebo Comparator: Placebo Group; 0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.	Drug: Control group; 0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Consumption of sufentanil via PCIA within 48 hours after the first study drug administration	0-48 hours post first study drug dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of rescue analgesia	Within0-24 hours and 0-48 hours after the first study drug administration
Cumulative consumption dose of rescue analgesia	within 0-24 hours and 0-48 hours after the first study drug administration
Time from end of surgery to first passage of flatus (hours)	Throughout the inpatient hospital stay after surgery, from the end of surgery until the first flatus occurs
Time from end of surgery to first defecation (hours)	Throughout the inpatient hospital stay after surgery, from the end of surgery until the first defecation occurs
Time from the end of surgery to first ambulation (hours)	Throughout the inpatient hospital stay after surgery, from the end of surgery until the first ambulation occurs
Incidence of nausea, vomiting and PONV	Within 48 hours after the first study drug administration
Patient satisfaction score for analgesia	Within 48 hours after the first study drug administration
Proportion of subjects with resting numerical rating scale (NRS) pain score ≥ 3	Within 0-24 hours and 0-48 hours after the first study drug administration
Resting numerical rating scale (NRS) pain score	At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration
Movement-evoked numerical rating scale (NRS) pain score	At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration
Incidence of rescue antiemetic treatment	Within 48 hours after the first study drug administration
Cumulative dose of rescue antiemetic treatment	Within 48 hours after the first study drug administration
Incidence of serious adverse events and study drug-related adverse events	Throughout the inpatient hospital stay after surgery, from the end of surgery until hospital discharge
Sleep quality score assessed using the Richards-Campbell Sleep Questionnaire (RCSQ; score range 0-100, higher scores indicate better sleep quality)	On the single night following the first administration of study drug
Cumulative consumption of sufentanil delivered via patient-controlled intravenous analgesia (PCIA)	Within 24 hours after the first study-drug administration
Serum biomarker concentrations: alanine transaminase (ALT), aspartate transaminase (AST), albumin (ALB), total bilirubin (TBIL), direct bilirubin (DBIL), indirect bilirubin (IBIL), international normalized ratio (INR)	Preoperative baseline (prior to surgical incision), and within the interval from 24 hours to 48 hours after the first administration of study drug
Proportion of subjects with movement-evoked Numerical Rating Scale (NRS) pain score ≥ 3	Within 0-24 hours and 0-48 hours after the first study-drug administration
Overall patient recovery quality score evaluated via the QoR-15 questionnaire (score range 0-150; higher scores indicate better recovery quality)	Within 48 hours after the first study-drug administration
Cumulative opioid consumption, converted to intravenous morphine milligram equivalents (MME)	Within the interval from 0 hours to 24 hours after the first administration of study drug, and within the interval from 0 hours to 48 hours after the first administration of study drug

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Principal Investigator: Changzhen Shang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: July 29, 2026
• First Submitted That Met QC Criteria: September 2, 2026
• First Posted (Actual): September 3, 2026

Study Record Updates

• Last Update Posted (Actual): September 3, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: laparoscopic hepatectomy; Anrikefon; postoperative acute pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Population Characteristics; Demography; Control Groups; Population Groups
• Other Study ID Numbers: SYSKY-2026-307-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No