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临床试验/NCT04777591
NCT04777591已完成4 期

Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction

University of Virginia2 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2021年3月1日最近更新:
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
117
试验地点
2
主要终点
Post-op Pain Scores During Initial Hospitalization

研究概览

简要总结

Transversus Abdominis Plane (TAP) block is a useful tool in pain management after abdominal surgery. It is a regional nerve block that targets T6-L1 thoracolumbar nerves running in the plane between internal oblique and transversus abdominis muscle. It is shown to help with post-operative pain management, reducing pain scores and narcotic pain medication use, as well as promoting earlier return to activity and recovery. TAP block became a very popular, safe, and effective therapeutic adjunct for many different abdominal surgeries ranging from obstetric procedures to general surgery procedures like colorectal surgery. Furthermore, it is used in plastic surgery procedures such as Deep Inferior Epigastric Perforator (DIEP) free flap or Transverse Rectus Abdominis Myocutaneous (TRAM) flap, as they involve extensive amount of abdominal soft tissue incision. Previous studies have shown that TAP block in these procedures significantly reduce post-op pain and narcotic pain medication use. More recently, Exparel (liposomal bupivacaine) has risen to spotlight for providing a longer, sustained local anesthesia. Various surgical disciplines have adopted this agent as part of their pain management protocol. However, there are no literatures that describe the effect of TAP block using Exparel for breast free flap population. The study hypothesize that delivering TAP block with Exparel (vs. plain bupivacaine) will provide longer regional blocking effect, hence aiding in pain control and recovery postoperatively. The investigators will be analyzing postop narcotic pain medication requirement and pain scores to look into this question.

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
Single (Participant)

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

  • All female patients who are 18 years or older who will undergo unilateral or bilateral abdomen-based free flap breast reconstruction at UVA Medical Center

排除标准

  • Subjects with ages <18 years
  • Allergy to local anesthetic
  • Inability to tolerate standard postoperative pain management regimen (Tylenol, Toradol, and Oxycodone PRN) for any reason
  • Subjects who cannot read or understand English
  • Subjects who are pregnant

研究组 & 干预措施

Control - plain bupivacaine

Active Comparator

Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively

干预措施: Bupivacain (Drug)

Experimental - Liposomal bupivacaine

Experimental

Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively

干预措施: Liposomal bupivacaine TAP block (Drug)

结局指标

主要结局

Post-op Pain Scores During Initial Hospitalization

时间窗: During initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first

Visual analog pain scale. Scores range from 0 to 10, 0 being no pain and 10 being worse pain that one experienced in their lifetime.

Post-op Narcotic Pain Medication Use During Hospitalization

时间窗: during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first

total amount of morphine milliequivalent

次要结局

  • Length of Hospital Stay(during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first)

研究者

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

John Stranix

Assistant Professor

University of Virginia

研究点 (2)

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