External Oblique Intercostal Block With or Without Intravenous Lidocaine Infusion for Analgesia in Patients Undergoing Gastric Bypass Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total intraoperative fentanyl consumption
研究概览
简要总结
Adding a perioperative lidocaine infusion (1.5 mg/kg loading + 1.5 mg/kg/h) to bilateral EOIB and low dose fentanyl loading reduces intraoperative fentanyl consumption (ANI guided rescue) compared to placebo, without increasing 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years.
- •BMI ≥ 35 kg/m².
- •ASA physical status II or III.
- •Scheduled for elective laparoscopic Roux en Y gastric bypass.
- •Ability to provide written informed consent.
排除标准
- •Allergy or contraindication to lidocaine, fentanyl, ropivacaine, or any study medication.
- •Chronic opioid use or dependence.
- •Significant hepatic (AST/ALT> 3× normal, cirrhosis) or renal impairment (CrCl< 30 mL/min).
- •Second or third degree AV block or significant bradyarrhythmia without pacemaker.
- •Coagulopathy, anticoagulation incompatible with regional anesthesia, or infection at block site.
- •Pregnancy or lactation.
- •Severe psychiatric or cognitive disorder.
- •Failed bilateral EOIB (absence of sensory loss in T6-T10 after 30 min) - excluded from analysis.
研究组 & 干预措施
Group P (placebo)
Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate).
干预措施: Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate). (Other)
Group L (lidocaine)
Bilateral EOIB + fentanyl 1 μg/kg loading + lidocaine 1.5 mg/kg loading + lidocaine infusion 1.5 mg/kg/h.
干预措施: Investigatore hypothesize that adding a perioperative lidocaine infusion (1.5 mg/kg loading + 1.5 mg/kg/h) to bilateral EOIB and low dose fentanyl loading reduces intraoperative fentanyl consumption. (Drug)
结局指标
主要结局
Total intraoperative fentanyl consumption
时间窗: Intraoperative time, during surgery
Total intraoperative fentanyl consumption (μg) = loading dose (1 μg/kg) + rescue boluses.
次要结局
- Postoperative morphine consumption(The first 24 hours)
- First rescue fentanyl and time to first postoperative morphine(The first 24 hours)
- Pain scores(Upon arrival, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours.)
研究者
Nevine Mostafa Soliman
Assistant Professor
Menoufia University