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临床试验/NCT03165383
NCT03165383已完成不适用

The Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane (TAP) Block in Lower Abdominal OncoSurgeries

Rajiv Gandhi Cancer Institute & Research Center, India0 个研究点目标入组 60 人开始时间: 2013年2月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
主要终点
Visual Analogue Pain Score in PACU in Transversus Abdominis Plane Block and Control Patient Group.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patient refusal to participate in the study, allergy to local anesthetics, coagulopathy, local skin infection at the site of TAP Block.

研究组 & 干预措施

Transversus Abdominis Plane (TAP) Block Group

Active Comparator

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.

干预措施: Bupivacaine (Transversus Abdominis Plane Block) (Drug)

Control Group (No TAP Block)

Placebo Comparator

The Transversus Abdominis Plane Block was not performed. Intravenous PCA Morphine was given as rescue analgesic upto 24 hours.

干预措施: Intravenous Patient Controlled Analgesia (PCA) Morphine (Drug)

结局指标

主要结局

Visual Analogue Pain Score in PACU in Transversus Abdominis Plane Block and Control Patient Group.

时间窗: up to 24 hours

In the PACU Visual Analogue Pain Score will be noted at rest and on knee flexion up to 24 hours.

次要结局

  • Total and Good demands for PCA IV Morphine in milligrams in both the groups.(up to 24 hours)

研究者

发起方
Rajiv Gandhi Cancer Institute & Research Center, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Anita Kulkarni

Principal Investigator

Rajiv Gandhi Cancer Institute & Research Center, India

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