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临床试验/NCT04382859
NCT04382859Unknown不适用

TOTEM: Trial of TAP Block Effective Medications

Western Michigan University School of Medicine2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
56
试验地点
2
主要终点
Pain rating 1 hour post operation

研究概览

简要总结

Our goal is to determine if liposomal bupivacaine compared to standard bupivacaine results in increased pain control and decreased narcotic pain medication use when used in TAP blocks prior to laparoscopic hysterectomies for benign indications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, 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

入选标准

  • Women undergoing non robotic assisted laparoscopic surgery for benign gynecologic conditions
  • English speaking

排除标准

  • Known current malignancy
  • Contraindication to medications

结局指标

主要结局

Pain rating 1 hour post operation

时间窗: 1 hour post operation

Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain

Pain rating 2 hours post operation

时间窗: 2 hours post operation

Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain

Pain rating 4 hours post operation

时间窗: 4 hours post operation

Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain

Pain rating 72 hours post operation

时间窗: 72 hours post operation

Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain

次要结局

未报告次要终点

研究者

发起方
Western Michigan University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melinda Abernethy

Associate Professor

Western Michigan University School of Medicine

研究点 (2)

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