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

Postoperative Pain Clinical Trial

— Painseverity  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06386250
• Other study ID #: 0005
• Status: Completed
• Phase: N/A
• Start date: January 5, 2019
• Est. completion date: January 6, 2020

Study information

• Verified date: April 2024
• Source: King Edward Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 6, 2020
• Est. primary completion date: January 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Pakistan	Muhammad Sharif	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
King Edward Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative pain intesity	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
Primary	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