NCT02858622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

2.1 years

First QC Date

April 5, 2016

Last Update Submit

May 3, 2019

Conditions

Renal Failure

Keywords

pediatricrenal transplantpaindual TAB

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • pain scoring system (objective behavioural pain score)

    from the time of transfer to the nephrology ICU, every hour for the first 24 hours postoperative

  • Intraoperative blood pressure

    from the induction of anesthesia till end of surgery at half an hour intervals average duration is 4 hours

  • postoperative blood pressure

    from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours

  • postoperative heart rate

    from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours

  • intraoperative heart rate

    from the induction of anesthesia till end of surgery at half an hour intervals average duration is 4 hours

Study Arms (2)

dual TAB group

ACTIVE COMPARATOR

22 patients will receive unilateral dual transversus abdominis plane (TAB) block USING bupivacaine 0.25% at a dose of 2 mg/kg

Drug: bupivacaineDrug: PethidineDrug: perfalganDrug: fentanyl

control group

SHAM COMPARATOR

22 patients who will not receive dual TAB block

Drug: PethidineDrug: perfalganDrug: fentanyl

Interventions

bupivacaineDRUG

bupivacaine 0.25% at a dose 2 mg/kg in the transversus abdominis plane

dual TAB group
PethidineDRUG

pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia

control groupdual TAB group
perfalganDRUG

intravenous paracetamol

control groupdual TAB group
fentanylDRUG
control groupdual TAB group

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • known allergy to bupivacaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Cairo University

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Renal InsufficiencyPain

Interventions

BupivacaineMeperidineFentanyl

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesIsonipecotic AcidsAcids, HeterocyclicHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Sherif M Soaida, M.D.

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 5, 2016

First Posted

August 8, 2016

Study Start

December 1, 2016

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Locations

EG(1)