NCT05969613

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 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

April 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2021

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

September 22, 2021

Last Update Submit

July 23, 2023

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (2)

  • 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.

    Within 24 hours

  • 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".

    Within 24 hours

Study Arms (3)

Regional Block

EXPERIMENTAL

Bupivacaine 0.25%

Procedure: Regional block

Wound infilteration

ACTIVE COMPARATOR

Bupivacaine 0.25%

Procedure: Wound infiltration

caudal block

ACTIVE COMPARATOR

Bupivacaine 0.25%

Procedure: Caudal block

Interventions

Regional blockPROCEDURE

regional block with 0.25% Bupivacaine at a dose of 2ml/kg with adrenaline

Regional Block
Wound infiltrationPROCEDURE

Infiltration of surgical site with 0.25% Bupivacaine at 0.5ml/kg dose

Wound infilteration
Caudal blockPROCEDURE

Infiltration of caudal epidural space with 0.25% Bupivacaine at 1ml/kg dose

caudal block

Eligibility Criteria

Age2 Months - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients under 13 years of age
  • Inguinal hernia

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)

Mayo Hospital

Lahore, Punjab Province, 55000, Pakistan

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mamoonullah Asmati

    King Edward Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Fatima Naumeri Associate Professor

Study Record Dates

First Submitted

September 22, 2021

First Posted

August 1, 2023

Study Start

April 1, 2019

Primary Completion

October 1, 2019

Study Completion

June 1, 2020

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations

PA(1)