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

Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02858622
• Other study ID #: SMS2016-1
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: March 2019

Study information

• Verified date: May 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

Inclusion Criteria:

• 3-16 years

• end stage renal disease

• no known allergy to bupivacaine

• both sexes

Exclusion Criteria:

• known allergy to bupivacaine

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• bupivacaine
bupivacaine 0.25% at a dose 2 mg/kg in the transversus abdominis plane
• Pethidine
pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia
• perfalgan
intravenous paracetamol
• fentanyl

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total dose of rescue analgesia	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	pain scoring system (objective behavioural pain score)		from the time of transfer to the nephrology ICU, every hour for the first 24 hours postoperative
Secondary	Intraoperative blood pressure	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
Secondary	postoperative blood pressure	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
Secondary	postoperative heart rate		from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
Secondary	intraoperative heart rate		from the induction of anesthesia till end of surgery at half an hour intervals average duration is 4 hours