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

NCT ID: NCT06386250

Last Updated: 2024-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-05

Study Completion Date

2020-01-06

Brief Summary

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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

Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Regional block group (Group A), wound infiltration group (Group B), caudal block group (Group C)
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

regional block

Intervention Type PROCEDURE

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.

Caudal block

Intervention Type PROCEDURE

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

Epidural

Intervention Type PROCEDURE

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

Group B

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

Group Type ACTIVE_COMPARATOR

regional block

Intervention Type PROCEDURE

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.

Caudal block

Intervention Type PROCEDURE

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

Epidural

Intervention Type PROCEDURE

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

Group C

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

Group Type EXPERIMENTAL

regional block

Intervention Type PROCEDURE

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.

Caudal block

Intervention Type PROCEDURE

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

Epidural

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Caudal block

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

Intervention Type PROCEDURE

Epidural

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

Intervention Type PROCEDURE

Other Intervention Names

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wound infilteration infilteration with 0.25% bupivacaine injection Bupivacaine into epidural space

Eligibility Criteria

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Inclusion Criteria

* Both Male and female inguinal hernia patients

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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Edward Medical University

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Sharif

PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammad Sharif, FCPS

Role: STUDY_CHAIR

King edward Medical University/Mayo Hospital Lahore

Locations

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Muhammad Sharif

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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0005

Identifier Type: -

Identifier Source: org_study_id

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