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

July 23, 2023 updated by: Fatima Numeri, King Edward Medical University

Comparison of Regional Block, Wound Infiltration and Caudal Block for Post Operative Pain Management in Children Undergoing Inguinal Herniotomy

Comparison of regional block, wound infiltration and caudal block for post operative pain management in participants undergoing inguinal herniotomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigators are comparing three modalities (regional block, wound infiltration and caudal block), for post operative pain management in participants after inguinal herniotomy.

Study Type

Interventional

Enrollment (Actual)

2

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

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 55000
        • Mayo 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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. •Patients under 13 years of age
  2. •Inguinal hernia

Exclusion Criteria:

  1. •History of allergy to any drugs used in study documented on history.
  2. •Infection at the site of regional, caudal or local infiltration, documented on clinical examination.
  3. •Irreducible, obstructed or strangulated hernia, documented on clinical examination.

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regional Block
Bupivacaine 0.25%
Procedure: Regional block
regional block with 0.25% Bupivacaine at a dose of 2ml/kg with adrenaline
Active Comparator: Wound infilteration
Bupivacaine 0.25%
Procedure: Wound infiltration
Infiltration of surgical site with 0.25% Bupivacaine at 0.5ml/kg dose
Active Comparator: caudal block
Bupivacaine 0.25%
Procedure: Caudal block
Infiltration of caudal epidural space with 0.25% Bupivacaine at 1ml/kg dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative pain -FLACC Pain sacle
Time Frame: Within 24 hours
Post operative pain management will be calculated by use of FLACC Pain scale . An overall pain score ranging from 0 to 10.
Within 24 hours
post operative pain -Wong-Baker Faces pain scale
Time Frame: Within 24 hours
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".
Within 24 hours

Collaborators and Investigators

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

Sponsor

King Edward Medical University

Investigators

  • Principal Investigator: Mamoonullah Asmati, King Edward Medical University

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 (Actual)

April 1, 2019

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

July 23, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 23, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fnaumeri

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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