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Effect of Bilateral Transversus Thoracis Muscle Plane Block in Patients Undergoing Coronary Artery Bypass Graft Surgery. (PARACABS)

2021年4月12日 更新者:University Hospital, Montpellier

Effect of Bilateral Transversus Thoracis Muscle Plane Block on Postoperative Morphine Consumption in Patients Undergoing Elective On-pump Coronary Artery Bypass Graft Surgery: a Retrospective Study.

Coronary artery bypass graft surgery is the standard surgical treatment for coronary disease. However, there is no consensus on analgesic management in patients undergoing CABG.

The aim of the study is to evualuate efficacy of bilateral transversus thoracis muscle plane (TTMP) block combined with systemic analgesia, compared to systemic analgesia only, in patients undergoing elective on-pump CABG surgery.

Our main hypothesis is that a bilateral TTMP block performed after CABG surgery could reduce morphine consumption during the first 48 hours.

The investigators conducted an age, gender and type of surgery-matched retrospective cohort study in the Montpellier University Hospital (France).

研究概览

研究类型

观察性的

注册 (实际的)

100

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

      • Montpellier、法国、34295
        • Uh Montpellier

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

取样方法

非概率样本

研究人群

"TTMP Block" group : fifty consecutive patients who underwent elective on-pump coronary artery bypass graft ± valve surgery after October 2019, with a postoperative analgesic protocol including a bilateral TTMP block, associate with systemic analgesia.

"Systemic Analgesia" group : age, gender and type of surgery-matched patients who underwent elective on-pump coronary artery bypass graft ± valve surgery before September 2019, with a postoperative analgesic protocol based on systemic analgesia only.

描述

Inclusion criteria:

  • To be over 18
  • To be scheduled for CABG surgery in the center of the study during the study period.

Exclusion criteria:

  • Chronic pain or opioid use before surgery
  • Recent thoracic regional analgesia (< 1 month)
  • Preoperative dementia or other neurologic or psychiatric disease incompatible with VAS pain scoring.
  • Other technique of regional anesthesia (e.g. thoracic epidural)
  • Opposition to data collection

Secondary exlusion criteria:

  • Postoperative prolonged sedation in ICU (> 12 hours)
  • Postoperative surgical complication requiring surgical revision during the first two days.
  • Opposition to data collection expressed secondarily

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

  • 观测模型:队列
  • 时间观点:追溯

队列和干预

团体/队列
干预/治疗
Systemic analgesia
Patients received only systemic analgesia : Acetaminophen, Ketoprofen, and Nefopam were administered systematically. Morphine was administered if necessary, according to our institutional pain management protocol.
Bilateral TTMP block + systemic analgesia
Patients received the same protocol of systemic analgesia associated with a bilateral TTMP block performed during the first four hours after ICU admission, before tracheal tube removal.
In the "TTMP block" group, an ultrasounded guided TTMP block was performed by an anesthesiologist, in ICU, before tracheal tube removal. Between the 4th et 5th rib, on each side, 40 ml of Ropivacaine 2 mg/ml, in association with Clonidine, was injected "single-shot" in the tranversus thoracis muscle plane. The targets of local anesthetic were the anterior branches of intercostal nerves from T2 to T6. Dexamethasone 8 mg was injected intravenously.
其他名称:
  • Transversus Thoracis Muscle Plane Block. Parasternal Block.

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
cumulative morphine consumption
大体时间:postoperative day 2
cumulative morphine consumption during the first two days. cumulative morphine consumption on postoperative day 0, 1 and 2, including the morphine administered in intensive care unit, and on postoperative day 1 and 2.
postoperative day 2

次要结果测量

结果测量
措施说明
大体时间
Postoperative pain assessed
大体时间:postoperative day 0, 1 and 2
Postoperative pain assessed by visual analog scale (VAS) scoring
postoperative day 0, 1 and 2
Postoperative nausea and vomiting
大体时间:hospital day 7
Postoperative nausea and vomiting
hospital day 7
Occurrence of prurit
大体时间:postoperative day 7
Occurrence of prurit
postoperative day 7
rate of Delirium
大体时间:postoperative day 7
rate of Delirium
postoperative day 7
rate of Constipation
大体时间:postoperative day 7
rate of Constipation
postoperative day 7
rate of Urinary retention
大体时间:until postoperative day 7
rate of Urinary retention
until postoperative day 7
rate of Hypotension
大体时间:until postoperative day 7
rate of Hypotension
until postoperative day 7
Pleural drain duration
大体时间:day 20
Pleural drain duration
day 20
Urinary catheter duration
大体时间:day 20
Urinary catheter duration
day 20
Duration of hospitalization in ICU
大体时间:day 20
Duration of hospitalization in ICU
day 20
In-hospital length of stay
大体时间:day 20
In-hospital length of stay
day 20
Occurrence of atrial fibrillation
大体时间:until postoperative day 7
Occurrence of atrial fibrillation
until postoperative day 7
rate of Pneumonia
大体时间:until postoperative day 7
rate of Pneumonia
until postoperative day 7
acute kidney injury
大体时间:until postoperative day 7
acute kidney injury
until postoperative day 7

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:Pierre Sentenac, MD, PhD、Uh Montpellier

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)

2018年1月1日

初级完成 (实际的)

2019年12月1日

研究完成 (实际的)

2019年12月20日

研究注册日期

首次提交

2021年3月23日

首先提交符合 QC 标准的

2021年4月12日

首次发布 (实际的)

2021年4月19日

研究记录更新

最后更新发布 (实际的)

2021年4月19日

上次提交的符合 QC 标准的更新

2021年4月12日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

NC

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

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.

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