The Analgesic Efficacy of Ultrasound Guided Transversus Abdominal Plane Block After Abdominal Cancer Surgeries (TAP)
2017年5月23日 更新者：Dr Anita Kulkarni、Rajiv Gandhi Cancer Institute & Research Center, India
The Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane (TAP) Block in Lower Abdominal OncoSurgeries
Effective postoperative pain control results in decreased cardiac and pulmonary complications, patient satisfaction and early mobilization.
A prospective, randomized comparative study was done of analgesic efficacy, opioid requirement and side effects in patients undergoing lower abdominal cancer surgeries.
In Study Group Ultrasound guided Transversus Abdominis Plane (TAP) block was given and control Group no TAP block was given.
Patient controlled analgesia (PCA) with intravenous morphine was given to both group patients, and total good PCA demands in both the groups was studied.
研究概览
地位
完全的
条件
详细说明
Adult patients of both sexes undergoing major lower abdominal cancer surgeries were enrolled in the study.
After obtaining written informed consent from all the patients, they were randomly allotted to either Study (TAP) Group or Control group.
Standard general anesthesia with endotracheal intubation was performed in all the patients.
Preoperatively all patients received information about Visual Analogue Scale (VAS) for Pain Score from 1 to 10 depending on intensity of pain and about the use of Patient Controlled Analgesia (PCA) Pump.
After the end of surgery and before extubation bilateral Ultrasound guided Transversus Abdominis Plane (TAP) block was performed with 16 G Tuohy needle and 18 G Braun Perifix epidural catheter was placed about 6-8 cms in situ.
Bupivacaine 0.25 % 20 ml was given bilaterally and repeated 8 hourly in the Postoperative Anaesthesia Care Unit (PACU) for first 24 hours.
The PCA Pump was set to deliver bolus Intravenous Morphine 1 milligram ( mg ) with lock out interval 10 minutes.
In the PACU heart rate, Non invasive blood pressure, Visual Analogue Score at rest and on knee flexion, Sedation score, nausea and vomiting, any side effects as itching was noted by care provider at 0, 2, 4, 6, 12, 18 and 24 hours.
Total and good PCA demands upto 24 hours was recorded.
研究类型
介入性
注册 (实际的)
60
阶段
- 不适用
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 65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:
- Adult patients belonging to American Society of Anesthesiologist (ASA) Physical Status I to III, for Open lower abdominal major onco surgeries more than 2 hours duration.
Exclusion Criteria:
- Patient refusal to participate in the study, allergy to local anesthetics, coagulopathy, local skin infection at the site of TAP Block.
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 (TAP) Block Group
Intervention - At the end of surgery Ultrasound guided Transversus Abdominis Plane block was given with 20 ml 0.25 % bupivacaine bolus and repeated every 8 hourly upto 24 hours.
|
Intervention - At the end of surgery Ultrasound guided Transversus Abdominis Plane block was given with 20 ml 0.25 % bupivacaine bolus and repeated every 8 hourly up to 24 hours.
|
|
安慰剂比较：Control Group (No TAP Block)
The Transversus Abdominis Plane Block was not performed.
Intravenous PCA Morphine was given as rescue analgesic upto 24 hours.
|
PCA Intravenous Morphine 1 milligram bolus on demand was given as rescue analgesia up to 24 hours.
|
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 |
|---|---|---|
|
Visual Analogue Pain Score in PACU in Transversus Abdominis Plane Block and Control Patient Group.
大体时间：up to 24 hours
|
In the PACU Visual Analogue Pain Score will be noted at rest and on knee flexion up to 24 hours.
|
up to 24 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total and Good demands for PCA IV Morphine in milligrams in both the groups.
大体时间：up to 24 hours
|
In the PACU, Total and Good PCA IV Morphine demands in milligrams in both groups was studied.
|
up to 24 hours
|
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：Anita Kulkarni, MD、Rajiv Gandhi Cancer Institute and Research Centre , Delhi , India 110085
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
- Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
- McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
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2月11日
初级完成 (实际的)
2014年7月10日
研究完成 (实际的)
2014年8月20日
研究注册日期
首次提交
2017年5月18日
首先提交符合 QC 标准的
2017年5月23日
首次发布 (实际的)
2017年5月24日
研究记录更新
最后更新发布 (实际的)
2017年5月24日
上次提交的符合 QC 标准的更新
2017年5月23日
最后验证
2017年5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.