Preventive Analgesia With Anrikefon in Laparoscopic Cholecystectomy

Официальное название

Effect of Preventive Analgesia With Anrikefon on Postoperative Acute Pain and Rehabilitation Process in Adult Patients Undergoing Laparoscopic Cholecystectomy

Обзор

This study will determine the optimal timing for Anrikefon administration. It will also assess the quality of patient recovery. Laparoscopic cholecystectomy (LC) is a routine surgical procedure. However, the incidence of acute visceral and incision pain is high, reaching 50% to 70%. This pain significantly impairs patient recovery. Anrikefon is novel peripherally restricted κ-opioid receptor agonist. It has very low brain penetration. This property reduces central nervous system side effects and respiratory depression. Preventive analgesia blocks the transmission of nociceptive stimuli to the central nervous system. It reduces postoperative pain sensitization and intensity. Currently, research on Anrikefon for preventive analgesia in LC patients is limited. It impacts on the recovery process is not yet fully understood. This study will compare drug administration before anesthesia induction with intra-operative administration. Participants will be assigned to one of two groups with equal probability using computer-generated random numbers. Patients in the Preventive Analgesia group will receive Anrikefon injection 15 minutes before anesthesia induction. Bridging Analgesia group is the control group. Patients in this group will receive Anrikefon immediately after the gallbladder is detached from the liver. Both groups will receive the identical drug dosage of 1 μg/kg. Both treatment groups will receive identical care beyond the time of Anrikefon administration. All patients will undergo standardized anesthesia management. Parecoxib sodium 40 mg will be injected for rescue analgesia if NRS score \> 4. We will analyze the primary, secondary, and exploratory outcome measures after surgery, aiming to explore the optimal timing of Anrikefon and its impact on the patient's recovery process.

Подробное описание

This study is a prospective, double-blinded, randomized controlled study. Adult patients (18-65 years old) who are planning to receive Laparoscopic Cholecystectomy will be enrolled into this study, and will be randomly divided according to 1:1. They will be named the preventive analgesia group and the bridging analgesia group. Primary end point is the time-weighted sum of pain intensity differences over 0-24 hours postoperatively (SPID₀-₂₄h) , which will be calculated according to the NRS scores at every time point(after surgery immediately ,15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, and 24 hours).

Вмешательства

• Препарат Anrikefon for Preventive Analgesia
  The Preventive Analgesia Group will receive intravenous Anrikefon (1 μg/kg) 15 minutes before anesthesia induction. Each bolus administration should be completed within 2 minutes ± 5 seconds.
• Препарат Anrikefon for bridging analgesia
  The Bridging Analgesia Group will receive intravenous Anrikefon (1 μg/kg) immediately after the gallbladder is removed from the liver bed. Each bolus administration should be completed within 2 minutes ± 5 seconds.

Первичные конечные точки

• The time-weighted sum of pain intensity differences over 0-24 hours postoperatively of visceral pain [Срок оценки: From the end of surgery to 24 hours postoperatively]

Вторичные конечные точки (11)

• The time-weighted sum of pain intensity differences over 0-24 hours postoperatively of Incisional pain [Срок оценки: From the end of surgery to 24 hours postoperatively]
• The Numerical Rating Scale scores for visceral pain and incisional pain [Срок оценки: From the end of surgery to 24 hours postoperatively]
• Duration of postoperative incisional pain and visceral pain [Срок оценки: From the end of surgery to 72 hours postoperatively]
• Total Oxycodone consumption of the postoperative analgesia pump [Срок оценки: From the end of surgery to 48 hours postoperatively]
• Total Parecoxib sodium for rescue analgesia after surgery [Срок оценки: From the end of surgery to 72 hours postoperatively]
• 15-item Quality of Recovery scale [Срок оценки: at Day 1 and Day 3 after surgery]
• Recovery of gastrointestinal function [Срок оценки: From the end of surgery to Day 3 after surgery]
• Intake, Feeling nauseated, Emesis, Exam, and Duration of symptoms scoring system score [Срок оценки: 24 hours, 48 hours, and 72 hours after surgery]
• Length of hospital stay [Срок оценки: From the day of hospital admission to the day of discharge, on anverage of 3-5 days.]
• Rate of adverse reactions and complications [Срок оценки: From anesthesia induction to 72 hours after surgery]
• 30 days mortality [Срок оценки: from the end of surgery to 30 days after surgery]

Критерии участия

Критерии включения

• ASA physical status classification I-III;
• Age 18-65 years;
• Scheduled for elective laparoscopic cholecystectomy;
• Voluntary signed informed consent;
• BMI between 18-28 kg/m²;
• No history of general anesthesia surgery within the past 3 months.

Критерии исключения

• Severe cardiovascular disease, respiratory disease, or psychiatric disorders;
• Severe renal insufficiency;
• Recent use of diuretics or compound medications containing diuretics;
• Continuous use of opioid analgesics for more than 10 days within the past 3 months;
• Use of medications with unknown half-life affecting analgesic efficacy within 14 days prior to randomization;
• Pregnant women, lactating women, or those planning pregnancy in the near future;
• History of hypersensitivity to study medications.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xuanwu Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07566663 · Linyanshen[2026]008-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗