Comparison of the Analgesic Efficacy and Effects on Diaphragmatic Function of Bilateral Erector Spinae Plane Block and Bilateral Rhomboid Intercostal-Subserratus Plane Block in Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
This prospective randomized controlled trial aims to compare the analgesic efficacy and effects on diaphragmatic function of bilateral erector spinae plane (ESP) block and bilateral rhomboid intercostal-subserratus plane (RISS) block in patients undergoing elective laparoscopic cholecystectomy. Postoperative pain scores, opioid consumption, diaphragmatic excursion, pulmonary function, and recovery outcomes will be evaluated.
详细描述
Postoperative pain after laparoscopic cholecystectomy may impair respiratory function and delay recovery. Fascial plane blocks have emerged as effective opioid-sparing analgesic techniques. The erector spinae plane (ESP) block and rhomboid intercostal-subserratus plane (RISS) block are ultrasound-guided regional anesthesia techniques that may provide effective postoperative analgesia while preserving respiratory mechanics.
This prospective randomized controlled study will compare bilateral ESP block and bilateral RISS block in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia. The primary objective is to compare postoperative analgesic efficacy and diaphragmatic function. Secondary outcomes include postoperative opioid consumption, pain scores at rest and during movement, pulmonary function parameters, rescue analgesic requirements, and adverse events.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be blinded to group allocation. Regional blocks will be performed by an anesthesiologist not involved in postoperative assessments.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •ASA physical status I-III
- •Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- •Provision of written informed consent
排除标准
- •Coagulation disorders or anticoagulant therapy
- •Known allergy to local anesthetics
- •Infection at the block application site
- •Pregnancy or lactation
- •Chronic opioid use
- •Cognitive impairment
- •Refusal to participate in the study
- •Technical inability to perform the block
- •Failed block
研究组 & 干预措施
ESP Block
Patients will receive bilateral ultrasound-guided erector spinae plane block before laparoscopic cholecystectomy for postoperative analgesia.
干预措施: Erector Spinae Plane Block (Procedure)
RISS Block
Patients will receive bilateral ultrasound-guided rhomboid intercostal-subserratus plane block before laparoscopic cholecystectomy for postoperative analgesia.
干预措施: Rhomboid Intercostal-Subserratus Plane Block (Procedure)
研究者
Ferit Yetik
MD.
Bursa Yuksek Ihtisas Training and Research Hospital