External Oblique Intercostal Block Versus Erector Spinae Plane Block in Laparoscopic Bariatric Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Visual analogue pain score
研究概览
简要总结
This study aims to compare a single shot of bilateral ultrasound-guided EOI block and ESPB in terms of intraoperative opioid consumption, postoperative pain control in the first 24 hours, and the need for rescue analgesics.
详细描述
The study is randomized, controlled, double blinded trial and conducted in Cairo university hospital after approval of departmental and institutional research ethics committee. Written informed consent will be obtained from all participants. Randomization will be achieved using a computer-generated sequence. Concealment will be achieved using opaque envelopes.
On arrival of the patients to operating room, patients will be secured with 20 gauge intravenous cannula. Monitoring will include ECG, non-invasive arterial blood pressure (NIBP), and pulse oximetry (SpO2). Before receiving general anesthesia, patients will be randomly assigned into one of the two study groups; EOI block Group and ESPB Group.
Induction of general anesthesia will be induced with patients in ramped position and after adequate preoxygenation using 1 µg/kg fentanyl (based on lean body weight), 2 mg/kg propofol (based on total body weight), and 0.5 mg/kg atracurium (based on the ideal body weight), in addition to 8mg IV dexamethasone for prevention of postoperative nausea & vomiting. Endotracheal intubation will be established. Anesthesia will be maintained by 1.2% MAC of isoflurane with oxygen (50%) in air and 0.1 mg/kg of atracurium will be administered every 20 minutes as maintenance anesthetic drugs. Volume-controlled ventilation will be maintained with a tidal volume of 6 mL/kg of ideal body weight and the respiratory rate will be adapted to maintain ET CO2 between 30 and 40 mmHg, and a 10 cmH2O positive end-expiratory pressure (PEEP) will be applied in all patients. Monitoring through ECG, NIBP, pulse oximetry and capnography (ETCO2) continued throughout the surgeries.
US (Siemens ACUSON X300 Ultrasound System) guided blocks will be administered immediately after the induction of anesthesia and prior to surgical incision by consultant anesthesiologists who had experience in regional anesthesia and were familiar with the EOI and ESPB blocks.
EOI block Group (n=25): this group will receive bilateral ultrasound-guided external oblique intercostal block.
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
Randomization will be achieved using a computer-generated sequence. Concealment will be achieved using opaque envelopes
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
- •Obese patients of any gender with a body mass index (BMI) of ≥ 35 kg/m2 with comorbidities or > 40 kg/m2 and American Society of Anesthesiologists (ASA) physical status I-III and aged between 18 and 70 years scheduled for laparoscopic bariatric surgery, that is, sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB) surgery.
排除标准
- •Coagulopathy, infection at the injection site, allergy to local anesthetics, severe hepatic or renal disease, severe cardiopulmonary disease (≥ ASA IV), diabetic or other neuropathies, patients receiving opioids for chronic analgesic therapy, and inability to comprehend visual analogue scale (VAS).
结局指标
主要结局
Visual analogue pain score
时间窗: 24 hours
VAS Score at rest (static) and on movement (dynamic) at 2, 4, 6, 12, 18, and 24 hours postoperatively
次要结局
- First postoperative analgesic request(24 hours)
- Postoperative nausea and vomiting(24 hours)
- Time needed to perform the block(30-60 Minutes)
- Total morphine requirements(24 hours)
- Fentanyl consumption(Up to 4 hours)
- Complications related to the blocks(24 hours)
研究者
Nagy Malak , MD
Lecturer of anesthesia ,SICU and pain
Cairo University