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。

TAP Versus Thoracic Epidural in Major Abdominal Resections

2018年4月16日 更新者:Spectrum Health Hospitals

Efficacy and Safety of Transversus Abdominis Plane Blocks Versus Thoracic Epidural Anesthesia in Patients Undergoing Major Abdominal Resections: A Prospective, Randomized Controlled Trial

The purpose of this study is to compare two standard methods of pain control management used at Spectrum Health for patients undergoing major surgery. The two methods being compared are the thoracic epidural and the TAP block. The thoracic epidural method involves medication being given through a patient's back and the TAP block involves medication being given through a patient's abdomen (belly). The investigators will compare side effects experienced by the patients that take part in this study, including a change in blood pressure, as well as the patients' opinions about their pain management experience after surgery.

研究概览

详细说明

The purpose of this study is to compare the clinical profiles of two currently acceptable analgesia techniques in terms of incidence of hypotension with subsequent fluid administration and pain control by evaluation of both objective and subjective data. The investigators will also compare any additional hospital costs associated with side effect management related to either analgesia method.

This study is a prospective, randomized, open-label trial. Patients who agree to participate and satisfy the inclusion/exclusion criteria will be randomized at the time of enrollment into one of two groups (thoracic epidural or TAP block) using a randomization tool created for the study.

Patients will undergo their scheduled surgery and receive the analgesic method to which they have been randomized. Both methods (thoracic epidural or TAP block) are performed routinely at Spectrum Health and are considered routine care.

Data collected will include medical history and demographics from the patient's medical record. Intraoperative data will include length of surgery, estimated surgical blood loss, complications, blood pressure and medication requirements. Postoperative data will include episodes of hypotension (defined as a systolic BP < 90), fluid requirement in first 24 hours and first 72 hours, pain scores, narcotic usage, return to bowel function (as defined by flatus), time to tolerating a soft or regular diet, and complications. Data will also be collected via a survey each study patient will complete for study purposes only.

研究类型

介入性

注册 (实际的)

75

阶段

  • 不适用

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

    • Michigan
      • Grand Rapids、Michigan、美国、49503
        • Spectrum Health

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

全部

描述

Inclusion Criteria:

  • All patients male or female >18 years old who are scheduled to undergo a major abdominal surgery. Abdominal procedures include, but are not limited to: pancreaticoduodenectomies, distal pancreatectomies, bowel resection, liver resection, esophagectomies, heated intraperitoneal chemotherapy, retroperitoneal excisions and large genitourinary procedures
  • Patients determined by their surgeon as medically able to receive a thoracic epidural or a TAP block interchangeably after consideration of both procedures
  • Patient agrees to participate in this study and provides informed consent

Exclusion criteria:

  • Surgical cases combined with thoracic surgeries
  • Surgical cases where the abdominal operation is performed laparoscopically
  • Patients that have allergies to lidocaine, bupivacaine, levobupivacaine or hydromorphone
  • Patients that are on anticoagulation or antiplatelet medications at time of surgery other than aspirin
  • Surgical cases that typically do not require a regional block in addition to general anesthesia (e.g., cutaneous operations)
  • Adults unable to provide informed consent
  • Children
  • Pregnant women
  • Prisoners
  • Non-English speaking subjects
  • Any other medical condition including mental illness or substance abuse deemed by the investigator to be likely to interfere with a subject's ability to provide informed consent, cooperate and take part in this research study

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:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Transversus Abdominis Plane Block
Transversus Abdominis Plane Block Exparel 1.33% (20ml Volume)
Transversus Abdominis Plane Block
其他名称:
  • TAP块
  • 腹横肌平面阻滞
有源比较器:Thoracic Epidural Anesthesia
Thoracic Epidural Anesthesia 0.125% bupivicaine with 2 mcg/ml Fentanyl
Thoracic Epidural Anesthesia
其他名称:
  • 硬膜外
  • 胸段硬膜外麻醉

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
Hypotension
大体时间:First 24-72 hours postoperatively
The incidence of systolic blood pressure less than 90 mmHg and fluid requirements
First 24-72 hours postoperatively

次要结果测量

结果测量
措施说明
大体时间
Patient satisfaction relative to pain control and amount of additional narcotic usage
大体时间:Post operative day two during hospitalization
A short patient survey during the postoperative period which will collect information on pain management.
Post operative day two during hospitalization

其他结果措施

结果测量
措施说明
大体时间
Cost Evaluation
大体时间:Postoperative hospitalization an expected average of 6 months
Evaluate costs incurred relative to adverse side effect management and pain management related to either the TAP block or thoracic epidural.
Postoperative hospitalization an expected average of 6 months

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:Mathew Chung, MD、Spectrum Health Hospitals

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。

一般刊物

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)

2013年12月3日

初级完成 (实际的)

2016年8月1日

研究完成 (实际的)

2016年8月1日

研究注册日期

首次提交

2014年5月13日

首先提交符合 QC 标准的

2014年7月22日

首次发布 (估计)

2014年7月23日

研究记录更新

最后更新发布 (实际的)

2018年4月17日

上次提交的符合 QC 标准的更新

2018年4月16日

最后验证

2018年4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.

订阅