RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Tianjin Medical University Cancer Institute and Hospital • ClinicalTrials.gov ID: NCT07330063

Registry updated: 2026-09-22

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Description

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.

Interventions

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

Eligibility criteria

Inclusion Criteria: * Aged between 18 and 75 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.

Conditions

Gastrectomy Postoperative Analgesia

Locations

Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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