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Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy (LAVA)

2026年9月20日更新者：Asha Bhalwal、The University of Texas Health Science Center, Houston

Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy: LAVA Trial

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.

研究概览

地位

尚未招聘

条件

疼痛，术后

干预/治疗

研究类型

介入性

注册 (估计的)

104

阶段

阶段2
阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Asha B Bhalwal, MD
电话号码：(713) 566-4605
邮箱：Asha.B.Bhalwal@uth.tmc.edu

研究联系人备份

姓名：Aya Sasson Mohr
电话号码：(713) 500-6412
邮箱：Aya.MohrSasson@uth.tmc.edu

学习地点

美国
- Texas
  - Houston、Texas、美国、77030
    - The University of Texas Health Science Center, Houston
    - 接触：
      
      Asha B Bhalwal, MD
      
      电话号码：(713) 566-4605
      
      邮箱：Asha.B.Bhalwal@uth.tmc.edu
    - 接触：
      
      Aya Sasson Mohr
      
      电话号码：(713) 500-6412
      
      邮箱：Aya.MohrSasson@uth.tmc.edu

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

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.

Exclusion Criteria:

Combined operation or alternative approach
inpatient overnight admission

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：双倍的

手臂数量

武器和干预

参与者组/臂	干预/治疗
安慰剂比较：控制	药品：Normal Saline (NS) In addition to the Laparoscopic Transversus Abdominis Plane (TAP) Block, participants will get will get vaginal cuff infiltration with 20 cc of injectable NS at the end of the procedure.
实验性的：Combined Bupivacaine and Exparel	药品：Combined Bupivacaine and Exparel In addition to the Laparoscopic Transversus Abdominis Plane (TAP) Block, participants will receive 20 cc of a mixture of 40 cc of short term 0.25% bupivacaine hydrochloride and long term 20 mL of Exparel® (266 mg/20 mL) mixed with 100cc of normal saline (total amount 160 cc) to the vaginal cuff using William's cystoscopy needle. The mixture will be infiltrated evenly at the uterosacral ligament with care (10 cc on each uterosacral ligament) taken to distribute the injection across the full length of the cuff at the end of the procedure.

参与者组/臂

干预/治疗

安慰剂比较：控制

药品：Normal Saline (NS)

In addition to the Laparoscopic Transversus Abdominis Plane (TAP) Block, participants will get will get vaginal cuff infiltration with 20 cc of injectable NS at the end of the procedure.

实验性的：Combined Bupivacaine and Exparel

药品：Combined Bupivacaine and Exparel

In addition to the Laparoscopic Transversus Abdominis Plane (TAP) Block, participants will receive 20 cc of a mixture of 40 cc of short term 0.25% bupivacaine hydrochloride and long term 20 mL of Exparel® (266 mg/20 mL) mixed with 100cc of normal saline (total amount 160 cc) to the vaginal cuff using William's cystoscopy needle. The mixture will be infiltrated evenly at the uterosacral ligament with care (10 cc on each uterosacral ligament) taken to distribute the injection across the full length of the cuff at the end of the procedure.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Change in pain as assessed by the visual analog scale (VAS) 大体时间：4-6 hours post operation, postoperative day 1, postoperative day 3	Pain will be scored from 1-10 , higher number indicating more pain	4-6 hours post operation, postoperative day 1, postoperative day 3

次要结果测量

结果测量	措施说明	大体时间
Change in level of pain control achieved as assessed by the amount of nonsteroidal anti-inflammatory drugs (NSAIDs) needed 大体时间：2-week and 6- week follow up		2-week and 6- week follow up
Change in level of pain control achieved as assessed by the frequency of NSAIDS needed 大体时间：2-week and 6- week follow up		2-week and 6- week follow up
Change in level of pain control achieved as assessed by the amount of opioids needed 大体时间：2-week and 6- week follow up		2-week and 6- week follow up
Change in level of pain control achieved as assessed by the frequency of opioids needed 大体时间：2-week and 6- week follow up		2-week and 6- week follow up
Change in level of bleeding as assessed by the volume of blood loss reported by the surgeon 大体时间：2-week and 6- week follow up		2-week and 6- week follow up
Change in presence of vaginal dehiscence 大体时间：2-week and 6- week follow up	This will be categorically reported as a yes or no answer	2-week and 6- week follow up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The University of Texas Health Science Center, Houston

调查人员

首席研究员：Asha B Bhalwal, MD、The University of Texas Health Science Center, Houston

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月17日

初级完成 (估计的)

2028年3月17日

研究完成 (估计的)

2028年9月15日

研究注册日期

首次提交

2026年9月20日

首先提交符合 QC 标准的

2026年9月20日

首次发布 (实际的)

2026年9月25日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月20日

最后验证

2026年9月1日

Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy (LAVA)