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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: regional block; Procedure: Caudal block; Procedure: Epidural

• Registration Number: NCT06386250
• Lead Sponsor: King Edward Medical University

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

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 Timeline

• Study Start: 2019-01-05
• Primary Completion: 2020-01-06
• Study Completion: 2020-01-06
• Status Verified: 2024-04
• Study First Submitted: 2024-04-13
• Study First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Study First Posted: 2024-04-26
• Last Update Posted: 2024-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Epidural	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 C	Caudal block	In group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1.
Group A	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.
Group A	Caudal 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.
Group B	regional block	In group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site.
Group C	regional block	In group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1.
Group B	Caudal block	In group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site.
Group B	Epidural	In group B 0.25% bupivacaine 0.5ml/Kg was infiltrated at the surgical site.
Group C	Epidural	In group C 0.25% Bupivacaine 1ml /kg was given into epidural space at L4-L5 or L5-S1.

Primary Outcome Measures

Name	Time	Method
Postoperative pain intensity	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.

Trial Locations

Locations (1)

Muhammad Sharif; 🇵🇰 Lahore, Punjab, Pakistan