Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction
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
- 否
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
Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively
干预措施: Bupivacain (Drug)
Experimental - Liposomal bupivacaine
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
John Stranix
Assistant Professor
University of Virginia
