Recto-intercostal Fascial Plane Block Reduces Intraoperative Opioid and Volatile Anesthetic Use: a Randomized Trial in Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate whether an ultrasound-guided recto-intercostal fascial plane block performed before surgical incision in patients undergoing laparoscopic cholecystectomy reduces intraoperative opioid and volatile anesthetic consumption. Additionally, the study assesses its effects on postoperative pain and the incidence of nausea and vomiting.
详细描述
This prospective, randomized controlled trial is conducted at Etlik City Hospital and includes adult patients undergoing elective laparoscopic cholecystectomy. Institutional Ethics Committee approval is obtained, and the study is conducted in accordance with the Declaration of Helsinki.
Participants are randomly assigned into two groups using a closed-envelope method. All patients receive general anesthesia. After induction and intubation, the block group receives an ultrasound-guided recto-intercostal fascial plane block prior to surgical incision, while the control group receives standard analgesic management. Anesthesia is maintained at approximately 1 minimum alveolar concentration (MAC) with bispectral index (BIS) values between 40 and 60.
The primary outcome is intraoperative opioid and volatile anesthetic consumption. Secondary outcomes include intraoperative hemodynamic parameters, postoperative pain intensity assessed using the Numerical Rating Scale (NRS), and the incidence of postoperative nausea and vomiting (PONV).
The recto-intercostal fascial plane block is performed under ultrasound guidance by an experienced anesthesiologist under aseptic conditions. Local anesthetic is administered bilaterally into the fascial plane between the rectus muscle and the costal cartilage.
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
The block procedure is performed after induction of general anesthesia, and participants are unaware of group allocation. Postoperative outcome assessment is conducted by an investigator who is blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18-65 years
- •Scheduled for elective laparoscopic cholecystectomy
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Ability to provide written informed consent
排除标准
- •Refusal to participate
- •Known allergy to local anesthetics
- •Coagulopathy or anticoagulant therapy
- •Infection at the injection site
- •Body weight less than 75 kg
- •Severe hepatic or renal dysfunction
- •Pregnancy or breastfeeding
研究组 & 干预措施
block group
block group bilateral 30 mlbupivacaine 0.25%
干预措施: Procedure: Recto-intercostal fascial plane block (Procedure)
control group
研究者
Oya Kale
specialist anesthesia
Ankara Etlik City Hospital