Transverse Abdominal Plane Blocks for Bariatric Surgery Patients: A Single Blinded Randomized Controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Post Operative Opioid Usage
研究概览
简要总结
Addition of transverse abdominis plane (TAP) block to general anesthesia for morbidly obese patients (BMI >35) undergoing laparoscopic bariatric surgery for weight loss will significantly reduce opioid use in the recovery room
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be 18 years of age or older and able to provide his or her own consent.
- •The patient is scheduled for bariatric surgery including laparoscopic gastric banding, sleeve gastrectomy, and gastric bypass.
- •The patient must be surgically and medically accepted for the procedure
- •Good functional status, ability to perform activities of daily living
- •The patients BMI > 35, no upper limit
- •Signed study specific informed consent prior to enrollment
排除标准
- •Patients with an allergy to local anesthetics
- •Patients diagnosed with peripheral neuropathies including diabetes mellitus.
- •Patients with BMI <35
- •Patients with significant coronary artery disease
- •Patient refusal of block procedure.
- •Patients with chronic pain
- •Patients on pre-operative maintenance narcotics
- •American Society of Anesthesiologist classification system 4 (ASA 4) patients
研究组 & 干预措施
TAP, Bupivacaine
This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.
干预措施: Transverse abdominal plane block (Procedure)
TAP, Bupivacaine
This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Post Operative Opioid Usage
时间窗: 24 hour after surgery
The amounts of opioids used by the patient will be collected by a person blinded to the allocation group
次要结局
- Nausea: The Number of Participants Experiencing Nausea Will be Assessed by Chart Review(Up to 5 hours)
- Pain Score Assessed With Visual Analog Score (VAS)(30 minutes within arrival to PACU)
- Vomiting: The Number of Participants Experiencing Vomiting Will be Assessed by Chart Review(Up to 5 hours)
研究者
Karina Gritsenko
Assistant Professor
Montefiore Medical Center