The Effect of Liposomal Bupivacaine on Post Operative Pain and Narcotic Use After Bariatric Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- Morphine Equivalents
研究概览
简要总结
This study is prospective, randomized trial in which the efficacy of liposomal bupivacaine (Exparel®) is compared to standard bupivacaine local surgical site injection in reducing total IV and oral morphine equivalents required after laparoscopic bariatric surgery. Liposomal bupivacaine is a 72-hour bupivacaine that is slowly released from tissue over the course of three days. Having a long acting local anesthetic should provide better pain control than conventional bupivacaine which has a 3.5-hour half-life. In some studies, the use of liposomal bupivacaine has been shown to decrease pain and narcotic use after surgery. This has not yet been studied in bariatric patients and the use of liposomal bupivacaine can potentially improve patient post-operative pain control, decrease narcotic use, decrease hospital length of stay and readmission rates and improve patient satisfaction after bariatric surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients undergoing elective laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass surgeries.
- •Fulfills NIH criteria for bariatric surgery
排除标准
- •Patients deemed not a candidate for laparoscopic bariatric surgery
- •Patients with previous bariatric or gastric surgeries.
- •BMI <35 and > 60 kg/m2
- •Preoperative inability to ambulate and confined to wheelchair.
- •American Society of Anesthesiologist (ASA) score >3
- •Concurrent ventral hernia repair or intraoperative extensive lysis of adhesions
- •Not able to understand informed consent, or unwilling to sign consent.
- •Not able to understand and read English
- •Currently pregnant or lactating.
- •Age <18 or >65
- •Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.
- •Patients requiring opiate use within 30 days prior to time of surgery.
- •Patients with reported use of narcotics greater than 2 weeks in preceding year before surgery.
- •Patients with history of substance abuse, alcohol addiction
- •Patients with diagnosis of chronic pain, history of fibromyalgia, chronic regional pain syndrome (dystrophic pain syndrome).
- •Bupivacaine use within 96 hours before operation
- •Prisoners
- •Bariatric surgery operation >3 hours.
- •More than 5 laparoscopic incision sites used during surgery, conversion to open operation, placement of a feeding tube or drain.
- •Patients with renal failure or hepatic failure.
研究组 & 干预措施
Liposomal Bupivacaine
Liposomal bupivacaine (Exparel) 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites).
干预措施: Exparel 266 MG Per 20 ML Injection (Drug)
Control
60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites).
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Morphine Equivalents
时间窗: within 1 week post-operatively
in hospital total oral and IV morphine equivalents required after laparoscopic bariatric surgery.
次要结局
- Cumulative Pain Score(within 48 hours post operatively)