Autonomic Neural Blockade During Sleeve Gastrectomy and Gastric Bypass: A Randomized Controlled Trial Evaluating Pain and Nausea After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pain medication consumed post-operatively
研究概览
简要总结
The purpose of this research is to evaluate if autonomic nerve block (ANB- blocking pain and nausea signals) decreases pain and anti-nausea medication requirements as well as the experience of pain/nausea during the first 72 hours after sleeve gastrectomy or gastric bypass surgery. Participants will be randomly assigned either to the standard of care or the ANB group before surgery. As part of standard of care, in both groups, laparoscopic bariatric surgery will be initiated with local anesthetic injected into the abdominal wall. In the ANB group, participants will be given an additional injection of local anesthetic medication to block nerves on and around the stomach.
详细描述
Gastric bypass and sleeve gastrectomy are the most common and successful weight loss surgeries. The advancement of laparoscopic, minimally invasive techniques allows these procedures to be performed with low morbidity and a relatively easy recovery, when broadly considering abdominal surgery. The major complaints postoperatively are abdominal pain and nausea, which can require medications to control and may prolong hospital stay. There is evidence autonomic neural blockade (ANB) improves pain and nausea in the immediate postoperative period. ANB has been shown to be therapeutic in the surgical environment providing extended analgesia for pain following surgery.
This study is a single-blinded randomized controlled trial comparing the total morphine milligram equivalents (MMEs) of pain medication used 72 hours post-operative period in patients who received the ANB vs standard of care. In the ANB group, additional local anesthetic block of the neurovascular tissue along the lesser curve of the stomach and celiac trunk will be performed using 0.5% bupivacaine 10ml, 50mg and Liposomal bupivacaine 10ml, 133mg dose. Study participants will not be told if they received the block, but the surgeon will be aware of which study group participants are assigned.
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 (Participant)
盲法说明
The study participants will be blinded to treatment arm assignments.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals able and willing to consent and participate in all study activities
- •Adults, ages 18-90
- •All patients with severe obesity undergoing laparoscopic/robotic gastric bypass or sleeve gastrectomy
排除标准
- •Patients taking opiates chronically
- •Patients allergic to study medications
- •Patients with any prior adverse reaction to ingredients included in the block
- •Adults unable to consent
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Laparoscopic Paragastric Autonomic Neural Blockade
ANB will be performed in addition to administration of local anesthetic to abdominal incisions (standard of care). The block is administered via syringe attached to IV tubing and 25g hypodermic needle. The needle and tubing are introduced through a laparoscopic port with the cap in place, and the needle is grasped and cap removed in the abdomen. The needle is advance into perigastric tissue along the lesser curve, the lack of vascular penetration is confirmed with aspiration, and the anesthetic (0.5% bupivacaine-10ml, 50mg and Liposomal bupivacaine-10ml, 133mg) is injected. 10ml is distributed along the lesser curve, and 5ml on either side of the celiac trunk, identified by dividing the lesser omentum and elevating the stomach.
干预措施: Intraoperative autonomic neural blockade (ANB) (Procedure)
Laparoscopic Standard of Care Abdominal Wall Block
Laparoscopic bariatric surgeries are performed with local anesthetic injected into the abdominal wall only. This may be with transversus abdominis block or local injection at the port sites. At our institution, standard of care is local injection at port sites with bupivacaine (30ml) spread among the five small incisions. This standard will be maintained for every patient in the study.
干预措施: Laparoscopic Standard of Care Abdominal Wall Block (Procedure)
结局指标
主要结局
Pain medication consumed post-operatively
时间窗: Post-op 72 hours
Total Morphine milligram equivalents (MMEs) of pain medication utilized during the first 72hrs after bariatric surgery
次要结局
- Nausea, retching and vomiting symptoms(Post-op days 1, 2 and 3.)
- Numerical Pain Rating Scale(Day of surgery, post-op days 1, 2 and 3.)
- Nausea, retching and vomiting symptoms(Post-op days 1, 2 and 3.)
研究者
Herbert Hedberg
Gastrointestinal and General Surgery Physician
Endeavor Health