Comparative Study Between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for Post Operative Analgesia in Children Undergoing Infraumblical Surgeries

November 10, 2021 updated by: Haitham Mohamed Ismail, Sohag University
Comparative study between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for post operative analgesia

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Comparative study between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for post operative analgesia in children undergoing infraumblical surgeries

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 1

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: hala m hashem, assistant professor
  • Phone Number: 01004385249

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital

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

4 years to 7 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- 120 children, aged between 4 and 7 years undergoing infraumblical surgeries as ( hypospadias , inguinal hernia and orchopexy ).patients will be selected according to ASA physical status class I to II from both genders who be able to swallow tablets.

Exclusion Criteria:

  • parents' refusal.
  • urgent cases.
  • other contraindications of regional anesthesia (e.g. infection at injection site, coagulopathy and allergy to bupivacaine)
  • Insulin dependent diabetes
  • Thyroid disease

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group of Bupivacaine injection in Caudal block group
The children will receive of 0.25% plain bupivacaine infiltration as caudal block for post operative analgesia in infraumblical surgeries
Drug: Caudal Epidural Block using 0.25% plain bupivacaine dose 1 ml / kg and Ultrasound Guided Transversus Abdominis Plane Block using 0.25% plain bupivacaine dose 0.5 ml / kg
Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block using 0.25% plain bupivacaine
EXPERIMENTAL: Group 2 : Group of Bupivacaine injection in TAP block group
The children will receive of 0.25% plain bupivacaine infiltration as Transversus Abdominis Plane Block for post operative analgesia in infraumblical surgeries
Drug: Caudal Epidural Block using 0.25% plain bupivacaine dose 1 ml / kg and Ultrasound Guided Transversus Abdominis Plane Block using 0.25% plain bupivacaine dose 0.5 ml / kg
Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block using 0.25% plain bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative analgesia in infraumblicial surgeries in children children undergoing infraumblical surgeries
Time Frame: 6 months
Comparative study between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for post operative analgesia in children undergoing infraumblical surgeries.
6 months

Collaborators and Investigators

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

Sponsor

Sohag 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 (ANTICIPATED)

November 1, 2021

Primary Completion (ANTICIPATED)

April 1, 2022

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

October 17, 2021

First Submitted That Met QC Criteria

November 10, 2021

First Posted (ACTUAL)

November 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 10, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-10-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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