Intraoperative Autonomic Blockade to Prevent Early Postoperative Pain After Laparoscopic Cholecystectomy: A Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- postoperative analgesic doses
研究概览
简要总结
This study proposes infiltrating the hepatoduodenal ligament and the serosal reflection of the gallbladder cystic plate with a combination of Bupivacaine (a long-acting local anesthetic) and Dexamethasone (a corticosteroid). This technique aims to block the hepatic branches of the celiac plexus to improve visceral pain control and its associated clinical manifestations, reduce analgesic requirements, and lower readmission rates, thereby facilitating recovery.
详细描述
Introduction
Laparoscopic cholecystectomy is the second most commonly performed procedure by general surgeons. While laparoscopy results in shorter recovery times and less intense pain compared to open surgery, it does not entirely eliminate postoperative pain, which remains the primary reason for hospitalization or readmission. Consequently, most patients undergoing laparoscopic cholecystectomy require hospitalization for 24 to 48 hours.
Postoperative pain frequently occurs after cholecystectomy, stemming from surgical incisions, manipulation of surrounding tissues, and postoperative inflammation. Various methods for pain control have been investigated, including analgesics, anti-inflammatory medication, peripheral nerve blocks, and physical interventions.
This study proposes infiltrating the hepatoduodenal ligament and the serosal reflection of the gallbladder cystic plate with a combination of Bupivacaine (a long-acting local anesthetic) and Dexamethasone (a corticosteroid). This technique aims to block the hepatic branches of the celiac plexus to enhance visceral pain control and its associated clinical manifestations, reduce analgesic requirements, and lower readmission rates, thereby facilitating recovery.
Justification
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Randomization will be conducted using sealed envelopes stratified by the institution in blocks of six. The data manager will prepare and store the randomization list, and only they will have access to it during the study. The sealed envelopes will be placed in the patient's medical record and opened only when the patient is in the operating room and general anesthesia has been initiated. Both the patient and the independent investigator evaluating the data will remain blinded to the treatment group assignments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective or emergency laparoscopic cholecystectomy for cholelithiasis with or without cholecystitis.
排除标准
- •Associated biliary pathologies (e.g., biliary pancreatitis, cholangitis).
- •Additional procedures, such as formal bile duct exploration. Conversion to an open approach
- •Anesthesia or Surgical complications that require intensive care unit
- •Allergies to local anesthetics
结局指标
主要结局
postoperative analgesic doses
时间窗: up to 72 hours
acetaminophen 1g oral tablets
postoperative analgesic doses-rescue 1
时间窗: up to 72 hours
Ibuprofen 400 mg oral tablets
postoperative analgesic doses-rescue 2
时间窗: up to 72 hours
acetaminophen 300 mg plus codeine 8 mg oral tablets
postoperative analgesic-rescue 3
时间窗: up to 72 hours
Ketorolac (30 mg) + Hyoscine (20 mg) intramuscular ampules
次要结局
- pain level(1, 24 and 48 hours after surgery)