Ultrasound-guided Bilateral External Oblique İntercostal (EOI) Plane Block in Patients Undergoing 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
- 80
- 试验地点
- 2
- 主要终点
- Opioid consumption
研究概览
简要总结
This study will define the postoperative analgesic effect of ultrasound-guided bilateral External Oblique İntercostal (EOI) Plane Block and compare the control group in patients undergoing laparoscopic cholecystectomy.
The aim of this study is to compare postoperative opioid consumption of EOI plane block versus control group. It is hypothesized that postoperative opioid use will be less in patients with EOI plane block than in patients who only receive routine multimodal analgesia.
详细描述
Laparoscopy is a minimally invasive procedure, but postoperative pain is still the most common symptom after laparoscopic cholecystectomy (LC). Regional blocks used in addition to multimodal analgesia for postoperative pain after LC usually block the anterior branches of the intercostal nerves. After it was suggested by Hamilton et al. in 2018 that it could block the lateral cutaneous branches between T7-T11 intercostal nerve by administering local anesthetic to the thoracic facial plane and could be used in lateral abdominal surgeries, the EOI plane block has become a block that can be used for analgesic purposes in upper and lateral abdominal surgeries. Blocking the anterior and lateral branches together may produce analgesia in a wider area, resulting in less postoperative opioid consumption.
This study will be conducted as a single-center, prospective, randomized trial in a university hospital. Patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. After randomization, EOI Plane Block will be performed under ultrasound guidance after administering general anesthesia and prior to the skin incision. An anesthesiologist who performed blocks will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative opioid consumption,pain scores, nausea and vomiting, antiemetic use, and Quality of Recovery score will be blinded to group assignment.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Triple (Participant, Care Provider, Investigator) Blocks will be administered after induction of general Anesthesia so participants will be blinded to which intervention they have had.Study investigators will not be aware of what group the participant belongs to when assessing the patient at post-operative period
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients' age between 18 and 70 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery included in the study.
排除标准
- •presence of coagulation disorder
- •infection at the injection site of the block
- •known allergy to local anesthetics
- •advanced hepatic or renal failure
- •can not communicate in Turkish
- •history of abdominal surgery or trauma
- •conversion of laparoscopic to open surgery
- •consumption of any pain killers within the 24 h before the operation
- •chronic opioid consumption
- •pregnancy
- •alcohol or drug abuse
- •body mass index (BMI) ≥ 35 kg m-2.
结局指标
主要结局
Opioid consumption
时间窗: Postoperative 24 hours
If NRS score of the patient is equal or over 4, IV 50 mg tramadol will be applied as a rescue analgesic.
次要结局
- Adverse events(Postoperative 24 hours)
- Sedation score(Postoperative 24 hour)
- Numerical Rating Scale scores(Postoperative 24 hours)
- Metoclopromide consumption(Postoperative 24 hours)
- Quality of recovery levels between groups by using QoR-15 questionnaire(Postoperative 24th hour)
- Time to first rescue analgesic(Postoperative 24 hours)
研究者
muhammet korkusuz
Principal Investigator, MD
Karaman Training and Research Hospital