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Completed

NCT Number: NCT06386250

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

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muhammad Sharif

Lahore, Punjab Province, 53711, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Regional Block

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.

Other names: wound infilteration

Caudal block

Procedure

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

Other names: infilteration with 0.25% bupivacaine

Epidural

Procedure

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

Other names: injection Bupivacaine into epidural space

Primary outcomes

  1. Postoperative pain intensity

    Time frame: 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.

Other outcomes

  1. postoperative pain intesity

    Time frame: 24 hours

    Wong-Baker Faces pain Scale at 0, 1, 2, 4, 8, 24 hours after surgery in children more than 8 years of age.

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Official study title

Comparison of Regional Block, Caudal Block and Wound Infiltration for Post-operative Pain Management in Children Undergoing Inguinal Herniotomy

Acronym: Painseverity

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 26, 2024
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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