Comparison of Regional Block, Caudal Block and Wound Infiltration in Inguinal Hernitomy
Painseverity
1 other identifier
interventional
300
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 6, 2020
CompletedFirst Submitted
Initial submission to the registry
April 13, 2024
CompletedFirst Posted
Study publicly available on registry
April 26, 2024
CompletedApril 26, 2024
April 1, 2024
1 year
April 13, 2024
April 23, 2024
Conditions
Keywords
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 COMPARATORIn 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.
Group B
ACTIVE COMPARATORIn group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site.
Group C
EXPERIMENTALIn group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1.
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.
In group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site.
In group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1.
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Muhammad Sharif, FCPS
King edward Medical University/Mayo Hospital Lahore
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- 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