A Multicenter, Randomized, Parallel-Group Controlled Study Evaluating the Efficacy and Safety of Anrikefon in Postoperative Pain Management in Patients Undergoing Elective Laparoscopic Cholecystectomy Under General Anesthesia
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 144
- Locations
- 2
- Primary Endpoint
- Quality of Recovery-15 (QoR-15) scale at 24 hours postoperatively.
Study Overview
Brief Summary
This study is a multicenter, randomized, 1:1 parallel-group controlled clinical trial designed to evaluate the efficacy and safety of Anrikefon for postoperative analgesia in patients undergoing elective laparoscopic cholecystectomy (LC) under general anesthesia. Enrolled patients were randomly assigned to two groups (the Anrikefon group and the dizocine group) and received regular intravenous administration of the respective medication following the corresponding surgical procedure. The primary efficacy endpoint was the Quality of Recovery (QoR-15 score) at 24 hours postoperatively, combined with the Numerical Rating Scale (NRS), the Brief Pain Inventory (BPI), sleep quality (RCSQ), and postoperative recovery progress (time to first meal, first flatus, and first ambulation, etc.) for a comprehensive evaluation of efficacy; At the same time, safety indicators-including adverse events (such as nausea and vomiting, and shoulder and back pain), vital signs, and laboratory test results-were systematically monitored during the follow-up period to comprehensively evaluate the clinical utility of this protocol.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1.18 ≤ Age ≤ 70 years, no gender restriction.
- •2.American Society of Anesthesiologists (ASA) physical status classification I-II.
- •3.18 kg/m² ≤ BMI ≤ 30 kg/m².
- •4.Subjects undergoing elective LC under general anesthesia, with an estimated -surgical duration of ≤2 hours (including 1h).
- •5.Voluntarily agree to participate in the study and sign the informed consent form (ICF).
Exclusion Criteria
- •1.History of allergy to nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, or intraoperative anesthetics specified in the protocol.
- •2.Severe systemic diseases that, in the investigator's judgment, may significantly increase surgical risk or interfere with pain assessment (e.g., uncontrolled hypertension [SBP ≥170 mmHg and/or DBP ≥105 mmHg], uncontrolled hyperglycemia [fasting blood glucose ≥11.1 mmol/L], recent severe respiratory tract infection, severe gastritis, gastric/duodenal ulcers, upper abdominal surgery within 3 months, severe hepatic impairment [Child-Pugh score >9], chronic kidney disease [eGFR <60 mL/min/1.73m²]).
- •3.Substance abuse: Current drug or alcohol dependency.
- •4.Special populations: Pregnant or lactating women; any other conditions deemed unsuitable by the investigator.
- •5.Acute severe cholecystitis attack within the past 7 days, or subjects in whom malignant gallbladder lesions cannot be ruled out.
- •6.Presence of sleep disorders requiring pharmacological intervention; concomitant psychiatric disorders.
Outcomes
Primary Outcomes
Quality of Recovery-15 (QoR-15) scale at 24 hours postoperatively.
Time Frame: 24 hours after surgery
The QoR-15 scale was used 24 hours after surgery to assess the quality of patients' postoperative recovery. The total score of the QoR-15 scale ranges from 0 to 150, with higher scores indicating a better quality of postoperative recovery.
Secondary Outcomes
- Incidence of shoulder discomfort, back pain, nausea, and vomiting in each group.(24 hours after surgery)
- Resting and movement pain Numeric Rating Scale (NRS) Area Under the Curve (AUC 0-24h) after the initial dose(24 hours after surgery)
- Resting and movement (turning over) postoperative pain scores using the Numeric Rating Scale (NRS) at 0h, 2h, 8h, 16h, and 24h postoperatively.(24 hours after surgery)
- Rescue analgesic utilization: Cumulative consumption of rescue analgesia (meperidine 75 mg) at 0-12h and 0-24h after the first dose, number of rescue interventions, time to first rescue, and the percentage of subjects not requiring rescue analgesia.(24 hours after surgery)
- Time to first oral intake, time to first flatus/defecation, and time to first ambulation.(24 hours after surgery)
- Sleep quality on postoperative day 1 assessed by the Richards-Campbell Sleep Questionnaire (RCSQ).(24 hours after surgery)
- Postoperative Brief Pain Inventory (BPI) Scores(24 hours after surgery)
- Incidence and severity of adverse events (AEs).(2 weeks post-surgery)
- 12-Lead Electrocardiogram(Baseline and the 24 hours After Surgery)
- Cumulative use of antiemetics within 0-24 hours after the first postoperative dose in each group(24 hours after surgery)
- Proportion of patients in each group who received antiemetics within 0-24 hours after the first postoperative dose(24 hours after surgery)