Randomized Controlled Trial Investigating Use of Liposomal Bupivacaine in Bariatric Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Fentanyl PCA mcg
研究概览
简要总结
The aim of this study is to perform a randomized controlled trial for patients undergoing bariatric surgery, comparing the need for opiates with and without administration of a transversus abdominis plane (TAP) block using the long acting local anesthetic, liposomal bupivacaine (Exparel®). From this study, the investigators will assess whether use of long acting local anesthetic can reduce the need for opiates in the bariatric population.
详细描述
A prospective randomized controlled trial investigating the use of long acting local anesthetic for transversus abdominis block in patients undergoing bariatric surgery at Montefiore Medical Center. Patients will be randomized to either receive an intraoperative TAP block with LB, an intraoperative TAP block with RB, or no TAP block. All participants will receive standard post-operative analgesia regimen. Pain scores will be recorded by the nursing staff as reported by the patients for 24-36 hours post surgery. Patients will be monitored for secondary post-operative complications up to the 2-week mark following intervention.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese patients undergoing bariatric surgery (LSG or LRYGB)
- •Patients 18 years of age and older
- •Surgical treatment between 01/01/2018 and 12/31/2018 over a 1 year period
排除标准
- •Patients under the age of 18 years old
- •Patients taking any opiates within 30 days of enrollment in the trial
- •Patients with a history of chronic pain.
- •Patients taking pregabalin or gabapentin.
- •Prior laparotomy
- •Body Mass Index ≥ 60 kg/m2
- •History of cardiac arrhythmia
- •History of Seizure
- •Psychiatric Diagnosis currently on antipsychotic medication
研究组 & 干预措施
Liposomal Bupivacaine TAP block
Patients will be randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB will comprise of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline.
干预措施: Liposomal Bupivacaine TAP block (Drug)
Regular Bupivacaine TAP block
Patients will be randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB will comprise of 50mL of 0.25% bupivacaine and 100mL of normal saline.
干预措施: Bupivacaine TAP block (Drug)
结局指标
主要结局
Fentanyl PCA mcg
时间窗: 24 hours post surgery.
Fentanyl PCA (patient controlled analgesia) total microgram usage.
Total Fentanyl Usage
时间窗: During hospitalization, up to 7 days.
Total fentanyl usage in micrograms, including both PCA and IV push administered medication.
次要结局
- Length of Stay(Assessed every 24 hours post surgery, up to 168 hour post-surgery.)
- Acetaminophen Usage(During hospitalization, up t 7 days.)
- NSAID Usage(During hospitalization, up to 7 days.)
- Pain Score(24 hours post surgery.)
- Nausea(24 hours post surgery.)
- Time to Ambulation(Assessed every 24 hours post surgery, up to 168 hour post-surgery.)
研究者
Diego Camacho
Director Minimally Invasive and Endoscopic Surgery, Fellowship Program Director, Associate Professor of Surgery Albert Einstein College of Medicine, Montefiore Medical Center
Montefiore Medical Center