Single Blinded Randomized Trial of Transversus Abdominis Plane Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Mean 24 Hour Visual Analogue Scale (VAS) Pain Score
研究概览
简要总结
To investigate if laparoscopic Transversus Abdominis Plane (TAP) block using plain bupivacaine is equivalent to using liposomal bupivacaine in patients undergoing metabolic and bariatric surgery. The study will see if the plain bupivacaine group will be equivalent in terms of length of stay, Morphine Milligram Equivalents, Pain scores and patient satisfaction, but cost less.
详细描述
Compared to only Bupivacaine administered via TAP block, the study will investigate the analgesia effects to patients undergoing metabolic and bariatric surgery receiving TAP block with a Liposomal Bupivacaine mixture. To determine if patients undergoing metabolic and bariatric surgery receiving TAP block with a Liposomal Bupivacaine results in pain scores, as measured by visual analogic scale (VAS), that are equivalent compared to patients receiving TAP block with Bupivacaine only. Compared to TAP block with Bupivacaine only, the study will compare opioid consumption, and other effect differences to patients undergoing metabolic and bariatric surgery receiving TAP block with Liposomal Bupivacaine. The study will explore other effects, including pain score at 48 hours, and 72 hours after surgery, total opioid consumption required post op during their one-week post op visit as measured in morphine equivalences.
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
Patients will be blinded to type of Transversus Abdominis Plane (TAP) block used.
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
- •age > 18 years
- •Participants who can give written informed consent and willing to comply with all study-related procedures.
- •Patients undergoing primary sleeve gastrectomy or roux-en-y gastric bypass
排除标准
- •Patients undergoing duodenal switch procedures
- •Patients undergoing concomitant hiatal hernia repair or ventral hernia repair or cholecystectomy at time of primary metabolic surgery
- •Patients with chronic opioid use
研究组 & 干预措施
Bupivacaine only
Active control group patients receive Transversus Abdominis Plane (TAP) block with a Bupivacaine only mixture, containing 50 mL 0.5% Bupivacaine, and 100 mL normal saline solution.
干预措施: Bupivacaine Injection (Drug)
Liposomal Bupivacaine
Study group patients will receive Transversus Abdominis Plane (TAP) block with a Liposomal Bupivacaine mixture, containing 20 mL Liposomal Bupivacaine, 30 mL 0.5% Bupivacaine, and 100 mL normal saline solution.
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Mean 24 Hour Visual Analogue Scale (VAS) Pain Score
时间窗: Hour 24
Pain score at 24 hours post-operative, using visual analogue scale (VAS), ranging from 1 to 10. One indicates no pain, and 10 indicates the worst pain one could imagine.
次要结局
- Mean Visual Analogue Scale (VAS) Pain Scores(Hours,12, 48, and 72)
- Mean Average Morphine Equivalences(Day 3)
- Morphine Equivalences - Week 1(Week 1)
- Post-operative Nausea and Vomiting (PONV)(Week 1)
- Length of Hospital Stay(Day 3)
- Patient Satisfaction Scores(Day 30)