Dual Transversus Abdominis Plane Block in Pediatric Renal Transplant: Effect on Pain Control

May 3, 2019 updated by: Sherif Mohamed Abd el moneim Soaida, MD, Cairo University

Unilateral Dual Transversus Abdominis Plane Block in Pediatric Renal Transplant: A Randomized Control Study

Alleviating pain in children undergoing renal transplant is extremely challenging. Large incisions as those of renal transplant (Gibson's incision) require special techniques of pain control that don't affect hemodynamics or renal function. Since the transplant incision doesn't cross midline; a dual-TAP block is thought to be effective in providing pain control in such procedure as it will anesthetize the dermatomes T6-T12, the muscles of the anterior abdominal wall together with the underlying parietal peritoneum.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Faculty of Medicine, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 3-16 years
  • end stage renal disease
  • no known allergy to bupivacaine
  • both sexes

Exclusion Criteria:

  • known allergy to bupivacaine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: dual TAB group
22 patients will receive unilateral dual transversus abdominis plane (TAB) block USING bupivacaine 0.25% at a dose of 2 mg/kg
Drug: fentanyl
Drug: bupivacaine
bupivacaine 0.25% at a dose 2 mg/kg in the transversus abdominis plane
Drug: Pethidine
pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia
Drug: perfalgan
intravenous paracetamol
Sham Comparator: control group
22 patients who will not receive dual TAB block
Drug: fentanyl
Drug: Pethidine
pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia
Drug: perfalgan
intravenous paracetamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total dose of rescue analgesia
Time Frame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
pethidine given as rescue analgesia postoperative.
from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain scoring system (objective behavioural pain score)
Time Frame: from the time of transfer to the nephrology ICU, every hour for the first 24 hours postoperative
from the time of transfer to the nephrology ICU, every hour for the first 24 hours postoperative
Intraoperative blood pressure
Time Frame: from the induction of anesthesia till end of surgery at half an hour intervals average duration is 4 hours
measure systolic and diastolic blood pressure
from the induction of anesthesia till end of surgery at half an hour intervals average duration is 4 hours
postoperative blood pressure
Time Frame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
record systolic and diastolic blood pressure every hour for the first 24 hours postoperative
from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
postoperative heart rate
Time Frame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
intraoperative heart rate
Time Frame: from the induction of anesthesia till end of surgery at half an hour intervals average duration is 4 hours
from the induction of anesthesia till end of surgery at half an hour intervals average duration is 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Sherif M Soaida, M.D., Cairo university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 8, 2016

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMS2016-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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