Back to resultsDual Transversus Abdominis Plane Block in Pediatric Renal Transplant: Effect on Pain Control
Primary Purpose
Renal Failure
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
bupivacaine
Pethidine
perfalgan
fentanyl
Sponsored by
About this trial
This is an interventional other trial for Renal Failure focused on measuring pediatric, renal transplant, pain, dual TAB
Eligibility Criteria
Inclusion Criteria:
- 3-16 years
- end stage renal disease
- no known allergy to bupivacaine
- both sexes
Exclusion Criteria:
- known allergy to bupivacaine
Sites / Locations
- Faculty of medicine, Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
dual TAB group
control group
Arm Description
22 patients will receive unilateral dual transversus abdominis plane (TAB) block USING bupivacaine 0.25% at a dose of 2 mg/kg
22 patients who will not receive dual TAB block
Outcomes
Primary Outcome Measures
total dose of rescue analgesia
pethidine given as rescue analgesia postoperative.
Secondary Outcome Measures
pain scoring system (objective behavioural pain score)
Intraoperative blood pressure
measure systolic and diastolic blood pressure
postoperative blood pressure
record systolic and diastolic blood pressure every hour for the first 24 hours postoperative
postoperative heart rate
intraoperative heart rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02858622
Brief Title
Dual Transversus Abdominis Plane Block in Pediatric Renal Transplant: Effect on Pain Control
Official Title
Unilateral Dual Transversus Abdominis Plane Block in Pediatric Renal Transplant: A Randomized Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
pediatric, renal transplant, pain, dual TAB
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dual TAB group
Arm Type
Active Comparator
Arm Description
22 patients will receive unilateral dual transversus abdominis plane (TAB) block USING bupivacaine 0.25% at a dose of 2 mg/kg
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
22 patients who will not receive dual TAB block
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Intervention Description
bupivacaine 0.25% at a dose 2 mg/kg in the transversus abdominis plane
Intervention Type
Drug
Intervention Name(s)
Pethidine
Intervention Description
pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia
Intervention Type
Drug
Intervention Name(s)
perfalgan
Intervention Description
intravenous paracetamol
Intervention Type
Drug
Intervention Name(s)
fentanyl
Primary Outcome Measure Information:
Title
total dose of rescue analgesia
Description
pethidine given as rescue analgesia postoperative.
Time Frame
from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
Secondary Outcome Measure Information:
Title
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
Title
Intraoperative blood pressure
Description
measure systolic and diastolic blood pressure
Time Frame
from the induction of anesthesia till end of surgery at half an hour intervals average duration is 4 hours
Title
postoperative blood pressure
Description
record systolic and diastolic blood pressure every hour for the first 24 hours postoperative
Time Frame
from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
Title
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
Title
intraoperative heart rate
Time Frame
from the induction of anesthesia till end of surgery at half an hour intervals average duration is 4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
3-16 years
end stage renal disease
no known allergy to bupivacaine
both sexes
Exclusion Criteria:
known allergy to bupivacaine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif M Soaida, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine, Cairo University
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
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Dual Transversus Abdominis Plane Block in Pediatric Renal Transplant: Effect on Pain Control
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