此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction

2019年2月13日 更新者：Washington University School of Medicine

A Prospective Trial to Assess Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction

This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in terms of discharge milestones, opioid use, costs, and patient-reported satisfaction at 12, 24, and 72 hours. The investigators propose that Exparel will lower opioid use, length of stay, and overall cost of abdominally-based autologous breast reconstruction, and will lead to greater patient satisfaction.

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

70

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

  • 美国
    • Missouri
      • Saint Louis、Missouri、美国、63110
        • Washington University School of Medicine

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 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Scheduled for abdominal-based autologous breast reconstruction (DIEP, MS-TRAM, or TRAM).
  • At least 18 years of age.
  • Female.
  • Able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

  • Cognitive impairment.
  • History of abdominal surgery precluding free flap donor site.
  • Allergy or intolerance to bupivacaine or "amide" anesthetics.
  • Significant preoperative chronic pain (requiring daily narcotics) or neuropathic pain (requiring daily use of pregabalin or gabapentin) within the previous 3 months.
  • Pregnant or breastfeeding.

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：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Group 1: Bupivicaine
-TAP block of 30 cc of 0.25% bupivicaine
药品：Bupivicaine HCL
其他名称：
  • 布比卡因
实验性的：Group 2: Liposomal bupivacaine
-TAP block of 266 mg/30 cc liposomal bupivacaine
药品：脂质体布比卡因
其他名称：
  • Exparel

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay
大体时间：Up to day of discharge from hospital (expected hospital stay of 5 days)
Up to day of discharge from hospital (expected hospital stay of 5 days)

次要结果测量

结果测量
措施说明
大体时间
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay
大体时间：Up to day of discharge from hospital (expected hospital stay of 5 days)
Up to day of discharge from hospital (expected hospital stay of 5 days)
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Length of Hospital Stay
大体时间：Up to day of discharge from hospital, up to 7 days
Up to day of discharge from hospital, up to 7 days
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Time Until Ambulation
大体时间：Up to 2 weeks post-operation
Up to 2 weeks post-operation
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Duration of Urinary Catheter
大体时间：Up to 2 weeks post-operation
Up to 2 weeks post-operation
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
大体时间：12 hours after surgery
  • Pain scale uses Wong-Baker FACES Pain Rating Scale
  • The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
12 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
大体时间：24 hours after surgery
  • Pain scale uses Wong-Baker FACES Pain Rating Scale
  • The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
24 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
大体时间：48 hours after surgery
  • Pain scale uses Wong-Baker FACES Pain Rating Scale
  • The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
48 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
大体时间：72 hours after surgery
  • Pain scale uses Wong-Baker FACES Pain Rating Scale
  • The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
72 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery
大体时间：At post operative day 2, discharge, and at 1-2 week follow-up
  • Quality of Recovery -15 questionnaire
  • Part A has 10 questions that asks how the participant has been feeling in the last 24 hours with answers ranging from 0=none of the time to 10=all of the time
  • Part B has 5 questions asking the participant if they have had any of the following including pain, nausea, vomiting, anxiety, and depression) with answers ranging from 0=none of the time to 10=all of the time.
  • The total score allowed is 150 (range 0-150) with the higher the number the worse the participant is feeling and the lower the number the better the participant is feeling
At post operative day 2, discharge, and at 1-2 week follow-up
Cost of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl When Accounting for Length of Hospital Stay and Use of Other Analgesics
大体时间：Up to 2 weeks post-operation
Up to 2 weeks post-operation

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。

赞助

Washington University School of Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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)

2016年2月29日

初级完成 (实际的)

2018年2月26日

研究完成 (实际的)

2018年3月8日

研究注册日期

首次提交

2016年1月20日

首先提交符合 QC 标准的

2016年1月22日

首次发布 (估计)

2016年1月25日

研究记录更新

最后更新发布 (实际的)

2019年2月18日

上次提交的符合 QC 标准的更新

2019年2月13日

最后验证

2019年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 201601064

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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.

脂质体布比卡因的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Uganda

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
订阅