Comparison of Regional Block, Caudal Block and Wound Infiltration in Inguinal Hernitomy (Painseverity)

April 23, 2024 updated by: Muhammad Sharif, King Edward Medical University

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

Background: Although Inguinal herniotomy in children is taken as a day care procedure, post-operative pain management still remain controversial in these cases and superiority of wound infiltration, caudal block or regional block over each isn't known.

Objective: The objective of the study was compare regional block, caudal block and wound infiltration for post-operative pain management in children undergoing inguinal herniotomy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Three hundred patients rom the department of pediatric surgery, KEMU/Mayo Hospital, were randomized in three study groups by a computer generated table. Regional block group (Group A), wound infiltration group (Group B), caudal block group (Group C). . Patients were assessed for postoperative pain intensity using FLACC pain scale at 0, 1, 2, 4, 8, 24 hours after surgery in children less than 8 years of age. Wong-Baker Faces pain Scale at 0, 1, 2, 4, 8, 24 hours after surgery in children more than 8 years of age. Patients were discharged after 24 hours. If pain score ≥ 4 was given intravenously, Ketoralac. Urinary retention was observed after 24 hours, wound infection was observed after 7 days.

Study Type

Interventional

Enrollment (Actual)

300

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, 53711
        • Muhammad Sharif

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

No

Description

Inclusion Criteria:

  • Both Male and female inguinal hernia patients
  • Patients from 3-12 years age 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.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
In group A, iliohypogastric and ilioinguinal nerves were blocked by using 0.25% bupivacaine 2ml/kg of combined with skin infiltration of adrenaline 1:200 000.
Procedure: regional block
In group A, iliohypogastric and ilioinguinal nerves were blocked by using 0.25% bupivacaine 2ml/kg of combined with skin infiltration of adrenaline 1:200 000.
Other Names:
  • wound infilteration
Procedure: Caudal block
In group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site.
Other Names:
  • infilteration with 0.25% bupivacaine
Procedure: Epidural
In group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1.
Other Names:
  • injection Bupivacaine into epidural space
Active Comparator: Group B
In group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site.
Procedure: regional block
In group A, iliohypogastric and ilioinguinal nerves were blocked by using 0.25% bupivacaine 2ml/kg of combined with skin infiltration of adrenaline 1:200 000.
Other Names:
  • wound infilteration
Procedure: Caudal block
In group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site.
Other Names:
  • infilteration with 0.25% bupivacaine
Procedure: Epidural
In group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1.
Other Names:
  • injection Bupivacaine into epidural space
Experimental: Group C
In group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1.
Procedure: regional block
In group A, iliohypogastric and ilioinguinal nerves were blocked by using 0.25% bupivacaine 2ml/kg of combined with skin infiltration of adrenaline 1:200 000.
Other Names:
  • wound infilteration
Procedure: Caudal block
In group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site.
Other Names:
  • infilteration with 0.25% bupivacaine
Procedure: Epidural
In group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1.
Other Names:
  • injection Bupivacaine into epidural space

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain intensity
Time Frame: 24 hours
Patients were assessed for postoperative pain intensity using FLACC pain scale at 0, 1, 2, 4, 8, 24 hours after surgery in children less than 8 years of age. Wong-Baker Faces pain Scale at 0, 1, 2, 4, 8, 24 hours after surgery in children more than 8 years of age.
24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain intesity
Time Frame: 24 hours
Wong-Baker Faces pain Scale at 0, 1, 2, 4, 8, 24 hours after surgery in children more than 8 years of age.
24 hours

Collaborators and Investigators

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

Sponsor

King Edward Medical University

Investigators

  • Study Chair: Muhammad Sharif, FCPS, king Edward medical university/mayo hospital lahore

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)

January 5, 2019

Primary Completion (Actual)

January 6, 2020

Study Completion (Actual)

January 6, 2020

Study Registration Dates

First Submitted

April 13, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0005 (VACHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

will be shared on request

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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