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临床试验/NCT02287623
NCT02287623已完成4 期

Subcostal TAP Block With Liposomal Bupivacaine vs Bupivacaine in Donor Nephrectomy Patients: A Prospective Randomized Study

University of Minnesota0 个研究点目标入组 60 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
主要终点
Numerical Rating Scale

研究概览

简要总结

The primary objective of this study is whether one local anesthetic, liposomal bupivacaine, provides improved pain control and decreased opioid use compared to bupivacaine when injected during a transversus abdominis plane block for donor nephrectomy patients.

详细描述

The primary objective of this study is whether one local anesthetic, liposomal bupivacaine, provides improved pain control and decreased opioid use compared to bupivacaine when injected during a transversus abdominis plane block for donor nephrectomy patients.

Background and treatment procedure: Liposomal bupivacaine is a multi vesicular formulation of bupivacaine that has been shown to provide up to 72 hours of analgesia compared to bupivacaine which provides up to 24 hours of analgesia post injection. These two medications have been compared using a infiltration or injection at the site of incision but have yet to be compared when used during a TAP block. A TAP block is an injection of local anesthetic under the covering of the transversus abdominis muscle layer. This layer is found using an ultrasound which is a beam of high frequency sound that allows one to visualize images in the body. Then using this ultrasound we can see our needle as it pierces the covering of the transversus abdominis muscle layer and watch as the local anesthetic is injected into this plane. This is done on both sides of the abdomen to provide analgesia to the skin, muscle, and fascial layers of the abdomen.

Population: Adult patients who are undergoing a donor nephrectomy Rationale: It will be useful to determine if one formulation or the other provides better and longer lasting pain control for patients undergoing abdominal procedures.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • presenting for donor nephrectomy

排除标准

  • non english speaking
  • chronic pain condition
  • taking chronic opioids

研究组 & 干预措施

liposomal bupivacaine TAP

Experimental

Patients will receive a TAP block with liposomal bupivacaine

干预措施: liposomal bupivacaine (Drug)

bupivacaine TAP

Active Comparator

Patients will receive a TAP block with bupivacaine

干预措施: bupivacaine (Drug)

结局指标

主要结局

Numerical Rating Scale

时间窗: 48-72 hours after injection

This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.

次要结局

  • Post Operative Length of Stay(up to 30 days after surgery)
  • Post Operative Opioid Use(0-24 hours)
  • Postoperative Opioid Use(24-48 hours)
  • Number of Patients With Post Operative Nausea/Vomiting(0-72 hours)

研究者

申办方类型
Other
责任方
Sponsor

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