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

ConditionGastrectomy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

114 Participants
are divided into 3 treatment groups
Group A: Placebo GroupPlacebo comparator 1 intervention
Group B: Anruikfen Intravenous Bolus Injection GroupExperimental treatment 1 intervention
Group C: Anruikefen Intravenous Infusion GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total Consumption of Sufentanil via PCIA

Time frame
within 48 Hours after the First Administration Postoperatively

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: