Efficacy and Safety of Anrikefon Injection for the Treatment of Postoperative Pain in Patients Undergoing Totally Laparoscopic Radical Distal Gastrectomy

Anruikefen is a peripherally highly selective kappa receptor agonist that does not easily cross the blood-brain barrier, resulting in a low incidence of central adverse reactions such as respiratory depression, sedation, and addiction. As a Class 1 new drug, it was approved for marketing in China on May 13, 2025, and is indicated for the treatment of postoperative pain following abdominal surgery. Results from two Phase Ⅲ randomized controlled trials (RCTs) of Anruikefen have demonstrated its significant analgesic efficacy, with the incidence of postoperative nausea and vomiting (PONV) being 50% significantly lower than that in the placebo group, which confirms the favorable safety profile of Anruikefen Injection.

Therefore, this investigator-initiated trial (IIT) is designed to further verify the efficacy and safety of Anruikefen in patients undergoing total laparoscopic distal gastrectomy for gastric cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastrectomy
• Intervention / Treatment: Drug: Placebo Group; Drug: Anruikefen (Intravenous Bolus); Drug: Anruikefen (Intravenous Infusion)

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Bin Ke; Phone Number: 022-23340123-1061; Email: binke@tmu.edu.cn

Study Locations

• China
  • 不限
    • Tianjin, 不限, China, 300000
      • Tianjin Medical University Cancer Institute & Hospital
      • Contact: Bin Ke

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Aged between 18 and 70 years old (inclusive).
• American Society of Anesthesiologists (ASA) physical status classification Class I-III.
• Body Mass Index (BMI) ranging from 18 kg/m² to 30 kg/m² (inclusive).
• Patients scheduled for elective total laparoscopic distal gastrectomy for gastric cancer under general anesthesia, with surgical duration < 5 hours.
• Surgical incision length < 8 cm.
• Voluntarily agree to participate in the trial and sign the informed consent form.

Exclusion Criteria:

• Patients undergoing emergency surgery or suffering from trauma.
• Patients who undergo conversion to open surgery or laparoscopically assisted distal gastrectomy for gastric cancer during the operation.
• Patients who refuse to receive Patient-Controlled Intravenous Analgesia (PCIA).
• Patients with a history of prior abdominal surgery.
• Patients expected to require prolonged endotracheal intubation after surgery.

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
Placebo Comparator: Placebo Group; Normal Saline via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.	Drug: Placebo Group; Normal Saline administered via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
Experimental: Anruikfen Intravenous Bolus Injection Group; Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.	Drug: Anruikefen (Intravenous Bolus); Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
Experimental: Anruikefen Intravenous Infusion Group; Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.	Drug: Anruikefen (Intravenous Infusion); Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Consumption of Sufentanil via PCIA	within 48 Hours after the First Administration Postoperatively

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 22, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Drug Administration Routes; Drug Therapy; Administration, Intravenous; Infusions, Parenteral; Infusions, Intravenous
• Other Study ID Numbers: E20251321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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