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Clinical Trials/NCT03165383
NCT03165383
Completed
Not Applicable

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

Rajiv Gandhi Cancer Institute & Research Center, India0 sites60 target enrollmentFebruary 11, 2013

Overview

Phase
Not Applicable
Intervention
Bupivacaine (Transversus Abdominis Plane Block)
Conditions
Abdominal Cancer
Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
Enrollment
60
Primary Endpoint
Visual Analogue Pain Score in PACU in Transversus Abdominis Plane Block and Control Patient Group.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 11, 2013
End Date
August 20, 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
Responsible Party
Principal Investigator
Principal Investigator

Dr Anita Kulkarni

Principal Investigator

Rajiv Gandhi Cancer Institute & Research Center, India

Eligibility Criteria

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.

Arms & Interventions

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: Bupivacaine (Transversus Abdominis Plane Block)

Control Group (No TAP Block)

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

Intervention: Intravenous Patient Controlled Analgesia (PCA) Morphine

Outcomes

Primary Outcomes

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

Time Frame: up to 24 hours

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

Secondary Outcomes

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

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