A Study on the Efficacy and Safety of Anrikefon for Postoperative Pain Relief Following Laparoscopic Cholecystectomy

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Anrikefon
  1.0 µg/kg per dose, administered by intravenous bolus injection every 8 hours at 0, 8, and 16 hours postoperatively, for a total of 3 doses. Specific preparation: Dilute 1.0 µg/kg of Anrikefon with 0.9% sodium chloride injection to a total volume of 10 mL.
• Препарат Dezocine
  5 mg/dose, IV bolus, q8h. Administered at 0h, 8h, and 16h postoperatively for a total of 3 doses.

Первичные конечные точки

• Quality of Recovery-15 (QoR-15) scale at 24 hours postoperatively. [Срок оценки: 24 hours after surgery]

Вторичные конечные точки (11)

• Resting and movement pain Numeric Rating Scale (NRS) Area Under the Curve (AUC 0-24h) after the initial dose [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 24 hours after surgery]
• Incidence of shoulder discomfort, back pain, nausea, and vomiting in each group. [Срок оценки: 24 hours after surgery]
• Time to first oral intake, time to first flatus/defecation, and time to first ambulation. [Срок оценки: 24 hours after surgery]
• Sleep quality on postoperative day 1 assessed by the Richards-Campbell Sleep Questionnaire (RCSQ). [Срок оценки: 24 hours after surgery]
• Postoperative Brief Pain Inventory (BPI) Scores [Срок оценки: 24 hours after surgery]
• Incidence and severity of adverse events (AEs). [Срок оценки: 2 weeks post-surgery]
• 12-Lead Electrocardiogram [Срок оценки: Baseline and the 24 hours After Surgery]
• Cumulative use of antiemetics within 0-24 hours after the first postoperative dose in each group [Срок оценки: 24 hours after surgery]
• Proportion of patients in each group who received antiemetics within 0-24 hours after the first postoperative dose [Срок оценки: 24 hours after surgery]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Affiliated Hospital of Guangdong Medical University — Zhanjiang
• The Second Affiliated Hospital of Guangdong Medical University — Zhanjiang

Идентификаторы

NCT: NCT07741188 · Anrikefon LC01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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