Ultrasound-guided Thoracic Paravertebral Block Using Ropivacaine With/Without Dexamethasone in Elective Thoracotomy
Study of Ultrasound-guided Thoracic Paravertebral Block Using Ropivacaine With/Without Dexamethasone in Elective Thoracotomy
The procedures of thoracotomy are among the most painful operations.
In addition to post-thoracotomy pain, the outcomes of surgery are affected adversely by postoperative discomfort.
Therefore, post-thoracotomy pain control can improve the satisfaction of patient and prevent postoperative complications such as pneumonia, atelectasis, or respiratory failure.
Thoracic epidural analgesia (TEA) used to be widely considered as a standard technique for providing analgesia after a thoracotomy.
However, TEA carries side-effects such as incomplete or failed block, epidural hematoma, abscess, hypotension, respiratory depression, or bradycardia, etc.
Recently, thoracic paravertebral block (TPVB) is an alternative technique for TEA that may offer a comparable analgesic effect and a better side -effect profile for post-thoracotomy analgesia.
When local anesthetic agents are used as single injection, they can provide analgesia for limited period.
Various adjuvants have been tried in the past in order to enhance the duration and quality of postoperative analgesia.
Previous studies with perineural dexamethasone demonstrated that it enhanced the duration of local anesthetic block.
The mechanism of its action is blocking the nociceptive impulse transmission along the myelinated C fibers.
Patient-controlled analgesia (PCA) devices have been shown to provide superior analgesia and greater patient satisfaction compared with intermittent administration.
System of wire-less PCA provides remote monitoring, information management and PCA devices with high precision.
The purpose of this research is to determine whether dexamethasone might prolong the duration of analgesia and improve the short-time outcomes when administered for TPVB along with local anesthetic agents in elective thoracotomy.
研究概览
研究类型
介入性
注册 (实际的)
68
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
-
-
Anhui
-
Hefei、Anhui、中国、230000
- The First Affiliated Hospital of Anhui Medical University
-
-
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
19年 至 80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:
- patient American Society of Anesthesiologists(ASA) I~III undergoing elective thoracotomy
- written informed consent from the patient or the relatives of the participating patient
Exclusion Criteria:
- mental illness
- thoracic paravertebral blocks contraindicated
- local anesthetic allergy
- people who have heart disease
- people who have severe liver or renal disease
- people who have severe endocrine disease
- people who can't communicate effectively because of hearing or visual disorders
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:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
假比较器:Group C(Control)
Group C received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.9% saline 20ml combined with general anesthesia and intravenous patient controlled analgesia pump.
|
ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.9% saline 20ml
其他名称:
|
实验性的:Group R(Ropivacaine)
Group R received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20 ml combined with general anesthesia and intravenous patient controlled analgesia pump.
|
ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml
其他名称:
|
实验性的:Group D(Dexamethasone)
Group D received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml and dexamethasone 5 mg combined with general anesthesia and intravenous patient controlled analgesia pump.
|
ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml
其他名称:
ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml and dexamethasone 5 mg
其他名称:
|
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 |
---|---|---|
the change of visual analogue scale(VAS) of patients with different treatment-related events in the following 3 days after thoracotomy
大体时间:6 hours,12hours,24hours and 72hours after operation
|
to show the grading of pain in different groups after surgery
|
6 hours,12hours,24hours and 72hours after operation
|
the reality pressing number of patient controlled analgesia(PCA) of patients with different treatment-related events in the following 3 days after surgery
大体时间:6hours,12hours,24hours and 72hours after operation
|
to show the consumption of analgesics after surgery
|
6hours,12hours,24hours and 72hours after operation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
hemodynamic index
大体时间:24 hours after anesthesia
|
To show the changing trend of hemodynamics with different treatment-related events when receiving thoracotomy.
|
24 hours after anesthesia
|
The time of recovery
大体时间:24 hours after surgery
|
to show the quality of recovery
|
24 hours after surgery
|
The time of extubation
大体时间:24 hours after surgery
|
to show the quality of recovery
|
24 hours after surgery
|
the incidence of side effects
大体时间:3days after operation
|
To compare the incidence rates of side effects, such as nausea, vomiting, dizziness, hypotension and bradyarrhythmia in the first 3 days after operation.
|
3days after operation
|
The complication after surgery
大体时间:30 days after surgery
|
To compare the incidence rates of complications, such as pneumonia, atelectasis, respiratory failure, heart failure, etc
|
30 days after surgery
|
The first day of leaving bed after surgery
大体时间:30 days after surgery
|
30 days after surgery
|
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。
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
- Carmona P, Llagunes J, Canovas S, de Andres J, Marques I. The role of continuous thoracic paravertebral block for fast-track anesthesia after cardiac surgery via thoracotomy. J Cardiothorac Vasc Anesth. 2011 Feb;25(1):205-6. doi: 10.1053/j.jvca.2010.04.005. No abstract available.
- Tomar GS, Ganguly S, Cherian G. Effect of Perineural Dexamethasone With Bupivacaine in Single Space Paravertebral Block for Postoperative Analgesia in Elective Nephrectomy Cases: A Double-Blind Placebo-Controlled Trial. Am J Ther. 2017 Nov/Dec;24(6):e713-e717. doi: 10.1097/MJT.0000000000000405.
- Ilfeld BM, Madison SJ, Suresh PJ, Sandhu NS, Kormylo NJ, Malhotra N, Loland VJ, Wallace MS, Proudfoot JA, Morgan AC, Wen CH, Wallace AM. Treatment of postmastectomy pain with ambulatory continuous paravertebral nerve blocks: a randomized, triple-masked, placebo-controlled study. Reg Anesth Pain Med. 2014 Mar-Apr;39(2):89-96. doi: 10.1097/AAP.0000000000000035.
- Ke JD, Hou HJ, Wang M, Zhang YJ. The comparison of anesthesia effect of lung surgery through video-assisted thoracic surgery: A meta-analysis. J Cancer Res Ther. 2015 Nov;11 Suppl:C265-70. doi: 10.4103/0973-1482.170534.
- Albrecht E, Kern C, Kirkham KR. A systematic review and meta-analysis of perineural dexamethasone for peripheral nerve blocks. Anaesthesia. 2015 Jan;70(1):71-83. doi: 10.1111/anae.12823. Epub 2014 Aug 14.
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6月1日
初级完成 (实际的)
2016年10月8日
研究完成 (实际的)
2017年1月20日
研究注册日期
首次提交
2016年7月17日
首先提交符合 QC 标准的
2016年8月12日
首次发布 (估计)
2016年8月18日
研究记录更新
最后更新发布 (估计)
2017年2月9日
上次提交的符合 QC 标准的更新
2017年2月8日
最后验证
2017年2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.