search
Back to results

Comparison of Regional Block, Wound Infiltration and Caudal Block for Pain Management in Children (RCT)

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Regional block
Wound infiltration
Caudal block
Sponsored by
King Edward Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia

Eligibility Criteria

2 Months - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: •Patients under 13 years of age •Inguinal hernia Exclusion Criteria: •History of allergy to any drugs used in study documented on history. •Infection at the site of regional, caudal or local infiltration, documented on clinical examination. •Irreducible, obstructed or strangulated hernia, documented on clinical examination.

Sites / Locations

  • Mayo Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Regional Block

Wound infilteration

caudal block

Arm Description

Bupivacaine 0.25%

Bupivacaine 0.25%

Bupivacaine 0.25%

Outcomes

Primary Outcome Measures

post operative pain -FLACC Pain sacle
Post operative pain management will be calculated by use of FLACC Pain scale . An overall pain score ranging from 0 to 10.
post operative pain -Wong-Baker Faces pain scale
The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable".

Secondary Outcome Measures

Full Information

First Posted
September 22, 2021
Last Updated
July 23, 2023
Sponsor
King Edward Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT05969613
Brief Title
Comparison of Regional Block, Wound Infiltration and Caudal Block for Pain Management in Children
Acronym
RCT
Official Title
Comparison of Regional Block, Wound Infiltration and Caudal Block for Post Operative Pain Management in Children Undergoing Inguinal Herniotomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Edward Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Comparison of regional block, wound infiltration and caudal block for post operative pain management in participants undergoing inguinal herniotomy.
Detailed Description
Investigators are comparing three modalities (regional block, wound infiltration and caudal block), for post operative pain management in participants after inguinal herniotomy.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regional Block
Arm Type
Experimental
Arm Description
Bupivacaine 0.25%
Arm Title
Wound infilteration
Arm Type
Active Comparator
Arm Description
Bupivacaine 0.25%
Arm Title
caudal block
Arm Type
Active Comparator
Arm Description
Bupivacaine 0.25%
Intervention Type
Procedure
Intervention Name(s)
Regional block
Intervention Description
regional block with 0.25% Bupivacaine at a dose of 2ml/kg with adrenaline
Intervention Type
Procedure
Intervention Name(s)
Wound infiltration
Intervention Description
Infiltration of surgical site with 0.25% Bupivacaine at 0.5ml/kg dose
Intervention Type
Procedure
Intervention Name(s)
Caudal block
Intervention Description
Infiltration of caudal epidural space with 0.25% Bupivacaine at 1ml/kg dose
Primary Outcome Measure Information:
Title
post operative pain -FLACC Pain sacle
Description
Post operative pain management will be calculated by use of FLACC Pain scale . An overall pain score ranging from 0 to 10.
Time Frame
Within 24 hours
Title
post operative pain -Wong-Baker Faces pain scale
Description
The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable".
Time Frame
Within 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: •Patients under 13 years of age •Inguinal hernia Exclusion Criteria: •History of allergy to any drugs used in study documented on history. •Infection at the site of regional, caudal or local infiltration, documented on clinical examination. •Irreducible, obstructed or strangulated hernia, documented on clinical examination.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mamoonullah Asmati
Organizational Affiliation
King Edward Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
55000
Country
Pakistan

12. IPD Sharing Statement

Learn more about this trial

Comparison of Regional Block, Wound Infiltration and Caudal Block for Pain Management in Children

We'll reach out to this number within 24 hrs