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

NCT07330063 | Not Yet Recruiting Phase 2

• 1 other identifier: E20251321
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrectomy

Outcome Measures

Primary Outcomes (1)

• Total Consumption of Sufentanil via PCIA

  within 48 Hours after the First Administration Postoperatively

Study Arms (3)

Placebo Group

PLACEBO COMPARATOR

Normal Saline via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Drug: Placebo Group

Anruikfen Intravenous Bolus Injection Group

EXPERIMENTAL

Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Drug: Anruikefen (Intravenous Bolus)

Anruikefen Intravenous Infusion Group

EXPERIMENTAL

Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.

Drug: Anruikefen (Intravenous Infusion)

Interventions

Anruikefen (Intravenous Infusion) DRUG

Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.

Anruikefen Intravenous Infusion Group

Anruikefen (Intravenous Bolus) DRUG

Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Anruikfen Intravenous Bolus Injection Group

Placebo Group DRUG

Normal Saline administered via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Placebo 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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, 不限, 300000, China

Location

MeSH Terms

Interventions

Infusions, Intravenous

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Central Study Contacts

Bin Ke

CONTACT

022-23340123-1061; binke@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: December 22, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Locations

CN (1)