RCT: Comparison of Regional Block, Wound Infiltration and Caudal Block for Pain Management in Children

• Sponsor: King Edward Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05969613
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arms: 3
• Actual Duration (Months): 14
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Comparison of regional block, wound infiltration and caudal block for post operative pain management in participants undergoing inguinal herniotomy.

Condition or Disease	Intervention/Treatment	Phase
Inguinal Hernia	Procedure: Regional block; Procedure: Wound infiltration; Procedure: Caudal block	N/A

Detailed Description

Investigators are comparing three modalities (regional block, wound infiltration and caudal block), for post operative pain management in participants after inguinal herniotomy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison of Regional Block, Wound Infiltration and Caudal Block for Post Operative Pain Management in Children Undergoing Inguinal Herniotomy
• Actual Study Start Date: Apr 1, 2019
• Actual Primary Completion Date: Oct 1, 2019
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Regional Block Bupivacaine 0.25%	Procedure: Regional block; regional block with 0.25% Bupivacaine at a dose of 2ml/kg with adrenaline
Active Comparator: Wound infilteration Bupivacaine 0.25%	Procedure: Wound infiltration; Infiltration of surgical site with 0.25% Bupivacaine at 0.5ml/kg dose
Active Comparator: caudal block Bupivacaine 0.25%	Procedure: Caudal block; Infiltration of caudal epidural space with 0.25% Bupivacaine at 1ml/kg dose

Outcome Measures

Primary Outcome Measures

1. post operative pain -FLACC Pain sacle [Within 24 hours]

   Post operative pain management will be calculated by use of FLACC Pain scale . An overall pain score ranging from 0 to 10.

2. post operative pain -Wong-Baker Faces pain scale [Within 24 hours]

   The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Months to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. •Patients under 13 years of age

2. •Inguinal hernia

Exclusion Criteria:

1. •History of allergy to any drugs used in study documented on history.

2. •Infection at the site of regional, caudal or local infiltration, documented on clinical examination.

3. •Irreducible, obstructed or strangulated hernia, documented on clinical examination.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Hospital	Lahore	Punjab	Pakistan	55000

Sponsors and Collaborators

• King Edward Medical University

Investigators

• Principal Investigator: Mamoonullah Asmati, King Edward Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fatima Numeri, Dr Fatima Naumeri Associate Professor, King Edward Medical University
• ClinicalTrials.gov Identifier: NCT05969613
• Other Study ID Numbers: Fnaumeri
• First Posted: Aug 1, 2023
• Last Update Posted: Aug 1, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hernia, Inguinal

Study Results

No Results Posted as of Aug 1, 2023