Efficacy of Laparoscopic Transversus Abdominis Plane (TAP) Block to Reduce Post-operative Opioids Following Bariatric and Minimally Invasive Foregut Surgery
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- opioid dosage requested
研究概览
简要总结
This study evaluates laparoscopic-guided TAP block for reducing opioid use after minimally invasive foregut and bariatric surgeries, comparing Bupivacaine HCL with Exparel®. Secondary outcomes include pain scores, length of stay, and PONV medication use.
详细描述
In this study the investigators aim to investigate the efficacy of laparoscopic-guided TAP block in reducing post-operative opioid use following minimally invasive foregut and bariatric surgeries. The investigators will also compare and report the analgesia produced by Bupivacaine HCL vs Exparel ®, a prolonged slow release Liposomal Bupivacaine formulation. Secondary outcomes assessed will be VAS pain scores, length of stay, and PONV dosage administered.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gastric bypass & sleeve gastrectomy, duodenal switch and minimally invasive elective anti-reflux foregut surgeries such as - hiatal hernia repair, fundoplication and Heller myotomy.
排除标准
- •Subjects who are known to be
- •Allergic to Bupivacaine
- •Chronic opioid users Page 4
- •Had/have neurological conditions
- •Have a diagnosis of chronic pain syndrome which requires them to consume regular analgesics > 3-months
- •American Society of Anesthesiologists (ASA) Class IV & V patients with severe systemic disease that is a constant threat to life.
- •Patients with abdominal drain use
- •Patients with significant cardiovascular, liver or renal disease
- •Presence of contraindications for bariatric or foregut surgery.
- •Patients presenting postoperative complications will be excluded from final analysis & final data set
- •History of bariatric or foregut surgery
- •Patients who are pregnant
- •Patients who are under the age of 18
研究组 & 干预措施
Group-1
Bilateral abdominal Lap-TAP block injection near incision site with 0.25% Bupivacaine HCl (30cc) with 30ml being injected bilaterally. Remaining residual is injected into port incision sites.
干预措施: Bilateral abdominal Lap-TAP (Drug)
Group-2
Bilateral abdominal Lap-TAP liposomal Bupivacaine (Exparel®) injection with 133mg (20ml) Exparel® plus bupivacaine 0.25% (30ml), plus 10ml of normal saline for a total volume of 60ml, injecting 30ml each side.
干预措施: Bilateral abdominal Lap-TAP (Drug)
Group-3
No intervention
结局指标
主要结局
opioid dosage requested
时间窗: 30days
opioid dosage requested post-TAP block
次要结局
- length of stay(30days)
- visual analog scores (VAS)(30days)
- anti-emetic dosage(30days)
研究者
Dan Davis
Medical Doctor
Baylor Research Institute