Caudal Epidural Catheterization in Pediatric Renal Transplant: Effect on Hemodynamics and Pain After Surgery

October 2, 2014 updated by: Sherif Mohamed Abd el moneim Soaida, MD, Cairo University

Caudal Extradural Catheterization in Pediatric Renal Transplant: Effect on Perioperative Hemodynamics and Pain Scoring.

pain control in pediatric renal transplant is a major concern. the main goal during anesthesia of renal transplant in pediatrics is to maintain hemodynamics in a range close to that of the adult donor. epidural analgesia is thought to be very effective in pain control. this study emphasises the ease of application of epidural catheter via the caudal route to the lower thoracic level; avoiding possible complications that may arise from lumbar or thoracic routes, and its effects on hemodynamics when using analgesic doses of local anesthetics and narcotics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 3-12 years
  • end stage renal disease
  • no known allergy to bupivacaine
  • both sexes

Exclusion Criteria:

  • known allergy to bupivacaine
  • inflammation at caudal area
  • spinal cord deformity

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: caudal epidural catheterization group
30 patients received continuous intra and post-operative caudal epidural infusion of bupivacaine 0.125% with fentanyl (2 microgram/ml) over 24 hours
Drug: Fentanyl
Drug: Bupivacaine
Drug: Pethidine
pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia
Device: B-Braun, Perifix® ONE Paed, Germany
caudal epidural catheterization bupivacaine fentanyl
Drug: Propofol
fentanyl propofol atracurium besylate
Sham Comparator: control group
30 patients didn't receive caudal epidural analgesia
Drug: Fentanyl
Drug: Pethidine
pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia
Drug: Propofol
fentanyl propofol atracurium besylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative blood pressure
Time Frame: from the induction of anesthesia till end of surgery at half an hour intervals
measure systolic and diastolic blood pressure
from the induction of anesthesia till end of surgery at half an hour intervals

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 central venous pressure
Time Frame: fromom the induction of anesthesia till end of surgery at half an hour intervals
fromom the induction of anesthesia till end of surgery at half an hour intervals
postoperative central venous pressure
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
from the induction of anesthesia till end of surgery at half an hour intervals

Other Outcome Measures

Outcome Measure
Time Frame
pain scoring system (objective behavioural pain score)
Time Frame: from the time of transfere to the nephrology ICU, every hour for the first 24 hours postoperative
from the time of transfere to the nephrology ICU, every hour for the first 24 hours postoperative

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 15, 2014

First Posted (Estimate)

January 16, 2014

Study Record Updates

Last Update Posted (Estimate)

October 6, 2014

Last Update Submitted That Met QC Criteria

October 2, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMS2014-1

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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