跳至主要内容
临床试验/NCT04849858
NCT04849858终止3 期

Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures: A Quality Improvement Project in Post-operative Pain

University of California, Irvine1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2019年5月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
入组人数
13
试验地点
1
主要终点
Post-operative opioid consumption

研究概览

简要总结

The purpose of this research study is to find out which type of transversus abdomens plane (TAP) and block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain medications.

详细描述

The purpose of this research study is to find out which type of TAP block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain medications.

An anesthesiologist participating on this study will describe the TAP block to you during your preoperative interview and will obtain your consent for the block procedure with your anesthesia consent prior to the procedure. TAP blocks are one of the various methods of controlling your pain after surgery. They are typically placed with an anesthetic agent, such as bupivacaine. The U.S. Food and Drug Administration (FDA) has recently approved a longer-acting form of the anesthetic used in this study, liposomal bupivacaine. Although both medications, bupivacaine and liposomal bupivacaine are approved by the FDA, there are only a few trials such as this one, in the United States, comparing the various types of TAP blocks. No studies exist comparing the re-dosing of a TAP block, as we will be doing in this study.

Currently, the standard of care after a gynecologic procedure may or may not include receiving a TAP block. This was a decision typically made, with your consent, at the discretion of an anesthesiologist and your surgeon. As per the standard of care, after surgery, you would be given oral pain medications to control your pain and intravenous pain medications for severe breakthrough pain. Our study will not change your post-operative pain medication schedule or timing. It will only study the effectiveness of the TAP block you get in controlling your pain.

Even though the medicines (bupivacaine or liposomal bupivacaine) used in this study are FDA-approved, the use of these drugs in this study is investigational.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Bupivacaine TAP Block

Active Comparator

The first 15 patients enrolled will receive perioperative plain bupivacaine TAP blocks.

干预措施: Bupivacaine (Drug)

Liposomal Bupivacaine TAP Block

Active Comparator

After enrolling all 15 participants in the first arm, the next 15 patients enrolled will receive perioperative single-dose Liposomal Bupivacaine TAP blocks.

干预措施: Liposomal bupivacaine (Drug)

Liposomal Bupivacaine TAP Block with Re-dosing

Active Comparator

After enrolling all 30 patients in the first two arms, the final 15 patients enrolled will receive perioperative Liposomal Bupivacaine TAP blocks followed by redosing of the TAP blocks in 48-60 hours.

干预措施: Liposomal bupivacaine (Drug)

结局指标

主要结局

Post-operative opioid consumption

时间窗: Post-operative day 0 to day 8

Morphine equivalents (milligrams)

次要结局

  • Bowel Function(Post-operative day 0 to day 8)
  • Pain at rest and during activity(Post-operative day 0 to day 8)
  • Nausea/Vomiting(Post-operative day 0 to day 8)
  • Hospital stay(Post-operative day 0 to day 8)
  • Ileus(Post-operative day 0 to day 8)
  • Ambulation(Post-operative day 0 to day 8)
  • Surgical Adverse Events(Post-operative day 0 to day 8)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jill Tseng

Assistant Professor

University of California, Irvine

研究点 (1)

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