Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy: LAVA Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in pain as assessed by the visual analog scale (VAS)
研究概览
简要总结
The purpose of this study is to compare recovery unit and post operation day (POD) 1 pain score in women following elective robotic assisted TLH (RA-TLH) for benign indication with and without local vaginal cuff injection of short acting bupivacaine and long acting Exparel, to evaluate postoperative pain management and control by assessing the amount and frequency of NSAIDS and opioids taken and to assess bleeding, vaginal discharge and or vaginal dehiscence at the postoperative follow up visit.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •at least 66.5kg weight
- •elective Robotic assisted (RA) Total Laparoscopic Hysterectomy (TLH) for benign indications at Memorial Hermann Hospital Texas Medical Center, Memorial Hermann Hospital Cypress and Memorial Hermann Hospital Greater Heights.
排除标准
- •Combined operation or alternative approach
- •inpatient overnight admission
研究组 & 干预措施
Combined Bupivacaine and Exparel
干预措施: Combined Bupivacaine and Exparel (Drug)
Control
干预措施: Normal Saline (NS) (Drug)
结局指标
主要结局
Change in pain as assessed by the visual analog scale (VAS)
时间窗: 4-6 hours post operation, postoperative day 1, postoperative day 3
Pain will be scored from 1-10 , higher number indicating more pain
次要结局
- Change in level of pain control achieved as assessed by the amount of opioids needed(2-week and 6- week follow up)
- Change in level of pain control achieved as assessed by the frequency of opioids needed(2-week and 6- week follow up)
- Change in level of bleeding as assessed by the volume of blood loss reported by the surgeon(2-week and 6- week follow up)
- Change in level of pain control achieved as assessed by the amount of nonsteroidal anti-inflammatory drugs (NSAIDs) needed(2-week and 6- week follow up)
- Change in level of pain control achieved as assessed by the frequency of NSAIDS needed(2-week and 6- week follow up)
- Change in presence of vaginal dehiscence(2-week and 6- week follow up)
研究者
Asha Bhalwal
Associate Professor Non-Tenure Clinical
The University of Texas Health Science Center, Houston