NCT02752230撤回4 期
Comparison of Exparel (Bupivacaine Liposome) to Marcaine (Bupivacaine) in Post-Surgical Analgesia for Laparoscopic Trocar Site Incisions in Bariatric Surgery
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Subjective Post Operative Pain Level
研究概览
简要总结
This study is designed to evaluate the use of bupivacaine liposome 1.3% compared bupivacaine 0.5% in pain control in post-operative laparoscopic bariatric surgery patient The purpose of this study is to evaluate two local anesthetics and determine if there is an advantage of administering one medication compared over the other. The intent is show that one local anesthetic.allows for improved pain control as per the pain scale ratings of the test subjects.
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient scheduled to undergo Laparoscopic Roux en Y Gastric Bypass or Laparoscopic Gastric Sleeve with Dr. Stephen Fleischer
排除标准
- •Patients with an allergy to either medications being studied any patient with neurological disorders that may be exacerbated by the use of either medication,including multiple sclerosis and amyotrophic lateral sclerosis or that may impact the perception of pain.
- •Patients with complex medical conditions that may confound data analysis per the principal investigator's discretion.
- •Any pregnant patient.Any patients that would not like to participate in the study.
- •Any patient that is not able to read or understand English
结局指标
主要结局
Subjective Post Operative Pain Level
时间窗: Within the first 10 days after surgery
Post operative pain will be assessed on an subjective level. The patient's pain will be assessed by the use of the Wong-Baker pain scale.
次要结局
未报告次要终点
研究者
Lauren Smith
Resident
Kettering Health Network
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