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

Phase 2RecruitingNCT07330063

Tianjin Medical University Cancer Institute and Hospital114 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

114

Conditions

Gastrectomy Postoperative Analgesia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Total Consumption of Sufentanil via PCIA

Time frame: within 48 Hours after the First Administration Postoperatively

Secondary Outcomes

Cumulative consumption of sufentanil delivered via patient-controlled intravenous analgesia (PCIA)

Time frame: From the end of surgery up to 24 hours after the first administration of study drug

Rest numerical rating scale (NRS) pain score assessed at baseline, 1 hour , 8 hours , 24 hours, and 48 hours after the first study drug administration;

Time frame: Baseline (immediately before the first study drug administration), 1 hour ± 30 minutes, 8 hours ± 2 hours, 24 hours ± 2 hours, and 48 hours ± 2 hours after the first administration of study drug

Dynamic numerical rating scale (NRS) pain score assessed at baseline, 1 hour , 8 hours , 24 hours, and 48 hours after the first study drug administration;

Peak rest numerical rating scale (NRS) pain score

Time frame: Within the period from 0 hours to 24 hours after the first administration of study drug

Peak dynamic numerical rating scale (NRS) pain score

Time frame: Within the period from 0 hours to 24 hours after the first administration of study drug

Incidence of rescue antiemetic treatment administration

Time frame: Within 48 hours after the first administration of study drug

I-FEED score

Time frame: At 24 hours, 48 hours, 72 hours, and 96 hours after the first administration of study drug

Time in hours from the end of surgery to the first oral intake

Time frame: Throughout the inpatient hospital stay after surgery

Time in hours from the end of surgery to the recovery of bowel function (defined as the first passage of flatus or first defecation)

Time frame: Throughout the inpatient hospital stay after surgery

Levels of inflammatory factors (IL-6, IL-10, TNF-α, CRP, NLR)

Time frame: Preoperative baseline (prior to surgery), before the first postoperative administration of study drug, and 48 hours after the first administration of study drug

Sleep quality （assessed via the Richards-Campbell Sleep Questionnaire） on the night of the first study drug administration

Time frame: On the single night following the first administration of study drug

Time (hours) from the end of surgery to the first out-of-bed ambulation

Time frame: Throughout the inpatient hospital stay following surgery

Total time (days) from surgery until patients meet discharge criteria

Time frame: during hospitalization

Total hospital length of stay measured in calendar days at the time of participant discharge after surgery

Time frame: At the moment of hospital discharge for each participant

Patient satisfaction score at 48 h after the first study drug administration

Time frame: At 48 hours after the first administration of study drug

Overall patient recovery quality score evaluated via the QoR-15 questionnaire

Time frame: At 24 hours, 48 hours, and 72 hours after the first administration of study drug

Incidence of Serious Adverse Events (SAEs)

Time frame: Throughout the inpatient hospital stay following surgery

Incidence of Treatment-Emergent Adverse Events (TEAEs) related to the study drug

Time frame: Throughout the inpatient hospital stay following surgery, during the period of study drug administration