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

Primary Purpose

Post Operative Analgesia in Children Undergoing Infraumblical Surgeries

Status

Recruiting

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Post Operative Analgesia in Children Undergoing Infraumblical Surgeries

Eligibility Criteria

4 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group of Bupivacaine injection in Caudal block group

Group 2 : Group of Bupivacaine injection in TAP block group

Arm Description

The children will receive of 0.25% plain bupivacaine infiltration as caudal block for post operative analgesia in infraumblical surgeries

The children will receive of 0.25% plain bupivacaine infiltration as Transversus Abdominis Plane Block for post operative analgesia in infraumblical surgeries

Outcomes

Primary Outcome Measures

post operative analgesia in infraumblicial surgeries in children children undergoing infraumblical surgeries

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05117021

First Posted

October 17, 2021

Last Updated

November 10, 2021

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT05117021

Brief Title

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

Official Title

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

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

November 2021 (Anticipated)

Primary Completion Date

April 2022 (Anticipated)

Study Completion Date

April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Comparative study between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for post operative analgesia

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Operative Analgesia in Children Undergoing Infraumblical Surgeries

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group of Bupivacaine injection in Caudal block group

Arm Type

Experimental

Arm Description

The children will receive of 0.25% plain bupivacaine infiltration as caudal block for post operative analgesia in infraumblical surgeries

Arm Title

Group 2 : Group of Bupivacaine injection in TAP block group

Arm Type

Experimental

Arm Description

The children will receive of 0.25% plain bupivacaine infiltration as Transversus Abdominis Plane Block for post operative analgesia in infraumblical surgeries

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block using 0.25% plain bupivacaine

Primary Outcome Measure Information:

Title

post operative analgesia in infraumblicial surgeries in children children undergoing infraumblical surgeries

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

haitham m esmail, resident doctor

Phone

01119775104

hitham0112245@med.sohag.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

hala m hashem, assistant professor

Phone

01004385249

Facility Information:

Facility Name

Sohag University Hospital

City

Sohag

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Osama R ELsheref, professor

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

33582009

Citation

Wang L, Xiao Y, Tian T, Jin L, Lei Y, Finnell RH, Ren A. Corrigendum to "Digenic variants of planar cell polarity genes in human neural tube defect patients." Mol Genet Metab. 2018 May;124(1):94-100. doi:10.1016/j.ymgme.2018.03.005. Epub 2018 Mar 18. https://pubmed.ncbi.nlm.nih.gov/29573971/. Mol Genet Metab. 2021 Mar;132(3):211. doi: 10.1016/j.ymgme.2021.01.010. Epub 2021 Feb 10. No abstract available.

Results Reference

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PubMed Identifier

33013030

Citation

Kumar A, Dogra N, Gupta A, Aggarwal S. Ultrasound-guided transversus abdominis plane block versus caudal block for postoperative analgesia in children undergoing inguinal hernia surgery: A comparative study. J Anaesthesiol Clin Pharmacol. 2020 Apr-Jun;36(2):172-176. doi: 10.4103/joacp.JOACP_100_19. Epub 2020 Jun 15.

Results Reference

background

PubMed Identifier

22077146

Citation

Willschke H, Kettner S. Pediatric regional anesthesia: abdominal wall blocks. Paediatr Anaesth. 2012 Jan;22(1):88-92. doi: 10.1111/j.1460-9592.2011.03704.x. Epub 2011 Nov 14.

Results Reference

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Learn more about this trial

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

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