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

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.

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.