Comparison of OSTAP, ESP Block,Injection of Local Anesthetic to Trocar Insertion for Elective Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative opioid consumption
研究概览
简要总结
Main purpose of this prospective single center randomized study is to compare the analgesic effect of ultrasound guided Unilateral Oblique Subcostal Transversus Abdominis Plane (TAP),unilateral Erector Spinae Plane (ESP) blocks and Port site infiltration of local anesthetic in subjects undergoing laparoscopic cholecystectomy. Total 100 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent laparoscopic cholecystectomy will recruit to the study.
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
- None
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
- •ASA Status 1-2 patients Exclusion criteria
- •Patients with a body mass index (BMI) of >40kg/m2
- •ASA score of >III
- •Previous abdominal surgery
- •Pregnant or breastfeeding patients
- •Patients with coagulopathy
- •Known local anesthetic allergy
- •infection at the injection site
排除标准
- 未提供
研究组 & 干预措施
Unilateral ESP Block
Before general anaesthesia, Ultrasound guided unilateral ESP block will perform with 15 ml of 0.5% bupivacaine and 5 ml 2% lidocaine.Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours.
干预措施: Unilateral ESP Block (Procedure)
Unilateral ESP Block
Before general anaesthesia, Ultrasound guided unilateral ESP block will perform with 15 ml of 0.5% bupivacaine and 5 ml 2% lidocaine.Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours.
干预措施: intravenous patient controlled analgesia (Drug)
Unilateral OSTAP block
Under general anaesthesia, Ultrasound guided unilateral OSTAP block will perform with 15 ml of 0.5% bupivacaine and 5 ml 2% lidocaine.Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours.
干预措施: Unilateral OSTAP Block (Procedure)
Unilateral OSTAP block
Under general anaesthesia, Ultrasound guided unilateral OSTAP block will perform with 15 ml of 0.5% bupivacaine and 5 ml 2% lidocaine.Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours.
干预措施: intravenous patient controlled analgesia (Drug)
Injection of Local Anesthetic to Trocar Insertion
After the laparoscopic surgery was completed, the trocar incision sites were closed. Following the infiltration rules, local anesthetic (15 ml of 0.5% bupivacaine and 5 ml 2% lidocaine) was applied to the trocar sites of skin, fascia, muscle, and preperitoneal area by the surgical team after the operation. A total of 20 mL of local anesthetic was used, with 6 mL for trocar sites of 10 mm, and 4 mL for trocar sites of 5 mm .Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours.
干预措施: Injection of Local Anesthetic to Trocar Insertion (Procedure)
Injection of Local Anesthetic to Trocar Insertion
After the laparoscopic surgery was completed, the trocar incision sites were closed. Following the infiltration rules, local anesthetic (15 ml of 0.5% bupivacaine and 5 ml 2% lidocaine) was applied to the trocar sites of skin, fascia, muscle, and preperitoneal area by the surgical team after the operation. A total of 20 mL of local anesthetic was used, with 6 mL for trocar sites of 10 mm, and 4 mL for trocar sites of 5 mm .Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours.
干预措施: intravenous patient controlled analgesia (Drug)
multimodal analgesia
Perioperative and postoperative routine analgesic protocol will be performed with no additional regional anesthesia method.Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours.
干预措施: intravenous patient controlled analgesia (Drug)
结局指标
主要结局
Postoperative opioid consumption
时间窗: 24 hours
Patient controlled analgesia (PCA) will provide with tramadol PCA. Total tramadol consumption will calculate and record till the postoperative 24th hours.
Postoperative pain scores: NRS
时间窗: 24 hours
Postoperative pain assessment will apply with numerical rating scale. These scores will record till the postoperative 24 th hours.
次要结局
- postoperative nause and vomiting(24 hours)
研究者
Burak Nalbant
Assistant Doctor
Diskapi Yildirim Beyazit Education and Research Hospital