A Phase 2 interventional study of Anruikefen (Intravenous Bolus) and Anruikefen (Intravenous Infusion) in Gastrectomy and Postoperative Analgesia, sponsored by Tianjin Medical University Cancer Institute and Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
Normal Saline via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
Drug: Placebo Group
Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
Drug: Anruikefen (Intravenous Bolus)
Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.
Drug: Anruikefen (Intravenous Infusion)
Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.
Normal Saline administered via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
Total Consumption of Sufentanil via PCIA
Time frame: within 48 Hours after the First Administration Postoperatively
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;
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
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
Plan to share: No
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Tianjin Medical University Cancer Institute and Hospital