Comparing Local Anesthetics for TAP Block During Abdominally-based Free Flap for Breast Reconstruction
2021年12月24日 更新者：Galen Perdikis、Vanderbilt University Medical Center
Double-Blinded Randomized Control Trial Comparing Liposomal Bupivacaine and Bupivacaine Hydrochloride in Transversus Abdominis Plane Blocks Prior To DIEP Flap for Breast Reconstruction
This study will compare the efficiency of transversus abominus plane (TAP) block using liposomal bupivacaine versus plain bupivacaine that is administered in the operating room under ultrasound guidance prior to the in patients undergoing abdominally-based free flap breast reconstruction at Vanderbilt University Medical Center.
研究概览
地位
完全的
详细说明
Transversus Abdominis Plane (TAP) blocks are commonly used as part of Enhanced Recovery After Surgery (ERAS) pathway.
This prospective, double-blinded, randomized control trial compares post-operative pain and narcotic consumption after deep inferior epigastric artery perforator (DIEP) breast reconstruction with liposomal bupivacaine (LB) compared to bupivacaine hydrochloride (BHCl).
Subjects undergoing DIEP flaps were randomly assigned LB or BHCl, performed using ultrasound-guided TAP block technique pre-procedurally.
Primary outcomes were postoperative narcotic analgesia required in oral morphine equivalents (OME) from postoperative day (POD) 0 to 7. Secondary outcomes included POD 1-7 pain Numeric Rating Scale (NRS), non-narcotic pain medication consumption, time to first narcotic use, return of bowel function, and length of stay (LOS).
研究类型
介入性
注册 (实际的)
60
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Tennessee
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Nashville、Tennessee、美国、37212
- Vanderbilt University Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- age between 18-85 years
- males or females
- plastic surgery for abdominally-based free flap breast reconstruction.
Exclusion Criteria:
- those not candidates for TAP blocks due to allergies to the medications (e.g., bupivacaine)
- those with anatomic contra-indications to performing a TAP block
- those unwilling to participate in follow-up assessments
- vulnerable populations
- chronic pain or associated diagnosis
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：TAP block with liposomal bupivacaine
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia.
Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest.
The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane.
20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
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20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
其他名称：
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有源比较器：TAP block with regular bupivacaine
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia.
Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest.
The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane.
20mL of 0.25% bupivacaine injected on each side.
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20mL of 0.25% bupivacaine injected on each side.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)
大体时间：Postoperative day (POD) 1 to 7
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Amount of supplemental postoperative narcotic analgesia (both intravenous and oral) required by study groups in oral morphine equivalents
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Postoperative day (POD) 1 to 7
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain Measure
大体时间：Post operative day (POD) 1 to 7
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Pain as measured by numeric rating scale ranging from 0 (no pain) to 10 (worst pain ever).
|
Post operative day (POD) 1 to 7
|
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Time to First Opiate Use
大体时间：0-29.8 hours post operation
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Time from end of surgery to time of first opioid intake measured in hours
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0-29.8 hours post operation
|
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Time to Return of Bowel Function
大体时间：1 to 4 days post operation
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Mean time in days at which patients had a return of bowel movement post op
|
1 to 4 days post operation
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Length of Stay
大体时间：1 to 4 days
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Length of hospital stay post operatively
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1 to 4 days
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Ambulation
大体时间：1 day post op
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Time to first ambulate post op (in days)
|
1 day post op
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Non-narcotic Pain Medication Intake: Acetaminophen
大体时间：Post op day 1 to 7
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The total use of the non-narcotic pain medication Acetaminophen was recorded during hospitalization
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Post op day 1 to 7
|
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Non Narcotic Pain Medication Intake: Cyclobenzaprine
大体时间：Post op day 1 to 7
|
The total use of the non-narcotic pain medication Cyclobenzaprine was recorded during hospitalization
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Post op day 1 to 7
|
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Non Narcotic Pain Medication Intake: Gabapentin
大体时间：Post op day 1 to 7
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The total use of the non-narcotic pain medication gabapentin was recorded during hospitalization
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Post op day 1 to 7
|
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Non Narcotic Pain Medication Intake: Celebrex
大体时间：post op day 1 to 7
|
The total use of the non-narcotic pain medication celebrex was recorded during hospitalization
|
post op day 1 to 7
|
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Non Narcotic Pain Medication Intake: Ondansetron
大体时间：Post op day 1 to 7
|
The total use of the non-narcotic pain medication ondansetron was recorded during hospitalization
|
Post op day 1 to 7
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Galen Perdikis, MD、Vanderbilt University Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年6月13日
初级完成 (实际的)
2021年3月15日
研究完成 (实际的)
2021年3月30日
研究注册日期
首次提交
2018年10月2日
首先提交符合 QC 标准的
2018年10月6日
首次发布 (实际的)
2018年10月9日
研究记录更新
最后更新发布 (实际的)
2022年1月24日
上次提交的符合 QC 标准的更新
2021年12月24日
最后验证
2021年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.