The Effect of the Transversus Abdominis Plane Block to Postoperative Analgesia for Cesarean Section (TAP)
2018年8月14日 更新者:Gia Dinh People Hospital
The Transversus Abdominis Plane Block
The transversus abdominis plane block (TAP block) has effect to postoperative analgesia for cesarean section with spinal anesthesia but it was limited for cesarean section with general anesthesia.
The hypothesis that this technique has effect to postoperative analgesia for cesarean section with general anesthesia and it could reduce 50% of total morphine consumption during 24 hours after surgery.
研究概览
详细说明
This is a randomized, controlled, no-blind clinical trial.
The investigators selected 60 cases, who were cesarean section under general anesthesia, age from18 years, and American Society Anesthesiologists (ASA) classification was from II-III.
The cases of acute fetal impairment, local anesthesia contraindication, tolerance opioids, liver failure, renal failure, and spinal anesthesia failure were excluded.
All cases were randomized assigned two groups: the TAP block group (T group) and controlled group (C group).
Each group has 30 cases.
The TAP block was performed under the ultrasound guidance with 0.25% of ropivacaine 20 ml each side.
The both groups was treated postoperative analgesia with intravenous morphine to patients controlled analgesia (PCA).
The primary outcome was total morphine consumption during 24 hours after surgery.
The secondary outcomes were the time of required the first dose of morphine, pain score, the complications of TAP block, the side effects of morphine, and satisfaction score of participants.
Data was described and analyzed with SPSS 25.0.
The sample size was calculated with the hypothesis that TAP block could reduce 50% of dose morphine during 24 hours after surgery, 80% of power, 10% of loss, and 0.05 of alpha error.
研究类型
介入性
注册 (实际的)
60
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
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Ho Chi Minh、越南、700000
- THANG Nguyen Trong
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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 50年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- Cesarean section with general anesthesia.
- The ASA classification was from II to III
Exclusion Criteria:
- The acute fetal impairment.
- The severe live or renal failure.
- Tolerance opioids
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:其他
- 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 |
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有源比较器:T group
The TAP block group was called T group.
The participants were performed TAP block under guidance at the end of surgery.
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TAP block was performed under guidance with 0.25% ropivacaine 20 ml each side.
其他名称:
Single dose was 1 mg.
The locked time was 6 minutes.
The limited dose was 40 mg/ 4 giờ.
其他名称:
Ropivacaine 0.25% 20 ml each side
其他名称:
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安慰剂比较:C group
The controlled group was called C group.
The participants has not TAP block and were treated postoperative analgesia with intravenous morphine to patients controlled analgesia
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Single dose was 1 mg.
The locked time was 6 minutes.
The limited dose was 40 mg/ 4 giờ.
其他名称:
Ropivacaine 0.25% 20 ml 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 |
---|---|---|
Total morphine consumption during 24 hours
大体时间:24 hours
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Morphine was intravenous perfusion to participants during 24 hours with patients controlled analgesia (PCA).
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24 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The time required the first of dose of morphine (hours)
大体时间:24 hours
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The time was from the end of surgery to the participants required the first of dose of morphine with PCA.
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24 hours
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Pain score: VAS
大体时间:24 hours
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Pain score was measured with visual analogue scale (VAS).
VAS is from 0 to 10.
The zero is complete non-pain and the ten is severe pain
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24 hours
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The rate of complications of TAP block
大体时间:24 hours
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There were rate of systemic toxicity, puncture peritonea, and hematomae in abdominal wall
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24 hours
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The rate of side effect of morphine
大体时间:24 hours
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There were rate of sedation, respiratory failure, nause and vomiting, pruritus
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24 hours
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The satisfaction of participants: Likert
大体时间:24 hours
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It was evaluated with Linkert score.
Likerk score is from 1 to 5: 1-strongly disagree, 2-disagree, 3-neither agree nor disagree, 4-agree, 5-strongly agree
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24 hours
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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:THANG T Nguyen, Mr、Gia Dinh People Hospital
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)
2017年7月10日
初级完成 (实际的)
2017年7月15日
研究完成 (实际的)
2018年3月31日
研究注册日期
首次提交
2018年8月12日
首先提交符合 QC 标准的
2018年8月14日
首次发布 (实际的)
2018年8月16日
研究记录更新
最后更新发布 (实际的)
2018年8月16日
上次提交的符合 QC 标准的更新
2018年8月14日
最后验证
2018年8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.
TAP block的临床试验
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Royal College of Surgeons, Ireland尚未招聘疼痛 | 镇痛 | 手术 | 阑尾炎 | 腹腔镜 | 布比卡因
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Queen Mary University of LondonNational Health Service, United Kingdom未知