NCT06386250

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2020

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 26, 2024

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

April 13, 2024

Last Update Submit

April 23, 2024

Conditions

Keywords

Postoperative paininguinal herniotomychildrenregional blockcaudal blockwound infilteration

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain intensity

    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 Outcomes (1)

  • postoperative pain intesity

    24 hours

Study Arms (3)

Group A

ACTIVE COMPARATOR

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 blockProcedure: Caudal blockProcedure: Epidural

Group B

ACTIVE COMPARATOR

In group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site.

Procedure: regional blockProcedure: Caudal blockProcedure: Epidural

Group C

EXPERIMENTAL

In group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1.

Procedure: regional blockProcedure: Caudal blockProcedure: Epidural

Interventions

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.

Also known as: wound infilteration
Group AGroup BGroup C
Caudal blockPROCEDURE

In group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site.

Also known as: infilteration with 0.25% bupivacaine
Group AGroup BGroup C
EpiduralPROCEDURE

In group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1.

Also known as: injection Bupivacaine into epidural space
Group AGroup BGroup C

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Both Male and female inguinal hernia patients

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhammad Sharif

Lahore, Punjab Province, 53711, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineInjections, Epidural

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesInjections, SpinalInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Muhammad Sharif, FCPS

    King edward Medical University/Mayo Hospital Lahore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Regional block group (Group A), wound infiltration group (Group B), caudal block group (Group C)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

April 13, 2024

First Posted

April 26, 2024

Study Start

January 5, 2019

Primary Completion

January 6, 2020

Study Completion

January 6, 2020

Last Updated

April 26, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

will be shared on request

Locations