External Oblique Intercostal Block for Postoperative Pain After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Total Butorphanolconsumption in the first 24 hours after surgery
研究概览
简要总结
This prospective, randomized, controlled, assessor-blinded trial will evaluate whether bilateral ultrasound-guided external oblique intercostal block (EOIB) reduces postoperative opioid consumption and improves recovery after laparoscopic cholecystectomy, compared with no block.
详细描述
Laparoscopic cholecystectomy is a common procedure, yet postoperative pain remains clinically significant despite routine multimodal analgesia, and opioid use may cause adverse effects. External oblique intercostal block (EOIB) is a newer ultrasound-guided fascial plane block that may provide effective analgesia for upper abdominal surgery.
This study is a prospective, randomized, controlled, assessor-blinded trial in patients undergoing elective laparoscopic cholecystectomy. A total of 56 participants will be randomized 1:1 to receive either bilateral ultrasound-guided EOIB or no regional block. EOIB will be performed bilaterally under ultrasound guidance at the level of the 6th rib in the 6th-7th intercostal space using an in-plane technique, with 15 mL of study local anesthetic mixture injected per side. Postoperatively, all participants will receive standardized multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with butorphanol and non-opioid analgesics per protocol.
The primary outcome is total opioid consumption during the first 24 hours after surgery. Secondary outcomes include postoperative pain scores (VRS) at prespecified time points, quality of recovery (QoR-15) at 24 hours, opioid consumption from 24-48 hours, postoperative nausea and vomiting, intraoperative hemodynamic events, time to first flatus, and length of hospital stay. The trial aims to determine whether adding bilateral EOIB to standard analgesia can reduce opioid requirements and improve recovery after laparoscopic cholecystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors are blinded to group assignment. Participants and clinical care providers/investigators are not blinded because the control group does not receive a regional block.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-85 years, regardless of gender
- •American Society of Anesthesiologists (ASA) physical status classification I-III
- •Scheduled for elective laparoscopic cholecystectomy
- •Ability to use the intravenous patient-controlled analgesia (IV PCA) system
排除标准
- •Hepatic disease (e.g., liver enzyme levels ≥ 2× the upper limit of normal)
- •Renal disease (e.g., serum creatinine levels ≥ 2× the upper limit of normal)
- •Allergy or known hypersensitivity to local anesthetics
- •Females who are pregnant or lactating
- •Conversion to open surgery
- •Coagulopathy or current use of anticoagulant medications
- •Opioid use for more than 2 weeks in the past 6 months
研究组 & 干预措施
EOIB Group
Participants receive bilateral ultrasound-guided external oblique intercostal block (EOIB) (15 mL of the study local anesthetic mixture per side) in addition to standard general anesthesia and standardized postoperative analgesia (IV PCA butorphanol ).
干预措施: External oblique intercostal block (EOIB) (Other)
Control Group
Participants do not receive any regional block. They receive standard general anesthesia and standardized postoperative analgesia only (IV PCA butorphanol).
干预措施: Standard care without regional block (Other)
结局指标
主要结局
Total Butorphanolconsumption in the first 24 hours after surgery
时间窗: 0-24 hours after surgery
Total Butorphanol consumption during the first 24 hours postoperatively. A relative difference of 30% is considered clinically significant.
次要结局
- Pain score (VRS) at 24 hours after surgery(24 hours after surgery)
- Quality of recovery at 24 hours (QoR-15 score)(24 hours after surgery)
- Postoperative length of hospital stay(Within 7 days after surgery)
- Butorphanol consumption from 24 to 48 hours after surgery(24-48 hours after surgery)
- Incidence of intraoperative hypotension and hypertension(Intraoperative period)
- Pain score (VRS) at 48 and 72 hours after surgery(48 hours and 72 hours after surgery)
- Incidence of postoperative nausea and vomiting within 72 hours(1-6 hours, 7-24 hours, 25-48 hours, and 49-72 hours after surgery (up to 72 hours))
- Time to first flatus(Within 3 days after surgery)
研究者
Shiyou Wei
Principal Investigator
Shanghai Pulmonary Hospital, Shanghai, China