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

简要总结

主要结局

次要结局

• Cumulative consumption of sufentanil delivered via patient-controlled intravenous analgesia (PCIA)(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;(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;(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(Within the period from 0 hours to 24 hours after the first administration of study drug)
• Peak dynamic numerical rating scale (NRS) pain score(Within the period from 0 hours to 24 hours after the first administration of study drug)
• Incidence of rescue antiemetic treatment administration(Within 48 hours after the first administration of study drug)
• I-FEED score(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(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)(Throughout the inpatient hospital stay after surgery)
• Levels of inflammatory factors (IL-6, IL-10, TNF-α, CRP, NLR)(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(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(Throughout the inpatient hospital stay following surgery)
• Total time (days) from surgery until patients meet discharge criteria(during hospitalization)
• Total hospital length of stay measured in calendar days at the time of participant discharge after surgery(At the moment of hospital discharge for each participant)
• Patient satisfaction score at 48 h after the first study drug administration(At 48 hours after the first administration of study drug)
• Overall patient recovery quality score evaluated via the QoR-15 questionnaire(At 24 hours, 48 hours, and 72 hours after the first administration of study drug)
• Incidence of Serious Adverse Events (SAEs)(Throughout the inpatient hospital stay following surgery)
• Incidence of Treatment-Emergent Adverse Events (TEAEs) related to the study drug(Throughout the inpatient hospital stay following surgery, during the period of study drug administration)