Comparing the Efficacy of Ultrasound Guided Erector Spinae Plane Block, Ultrasound Guided Caudal Block, and Local Infiltration for Postoperative Pain Control in Pediatric Patients Undergoing Unilateral Inguinal Hernia Repair as a Day-Case Surgeries: A Randomized Controlled Trial

NCT06849804 | Completed DMC

• 1 other identifier: 36264PR1045/1/25
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy of ultrasound guided Erector block versus caudal block versus local wound infiltration perioperatively according to: Primary outcome: to assess and compare the postoperative analgesic effect using pain score: Faces Legs Activity Cry Consolability tool (FLACC, 0- 10) at 15 min, 30 min and 1, 2, 3 and 4 h after operation Secondary outcomes: First dose of fentanyl as a rescue analgesia in dose of 0.5 μg/kg. Total doses of fentanyl as a rescue analgesia. Demographic data: age, sex, weight, ASA class. Hemodynamic parameter (MAP in (mm/hg) and heart rate (beats/minute)) Motor function will be assessed using the following scale: 0, no motor block; 1, able to move legs; 2, unable to move legs. Assessment of sedation will be done with objective score based on eye opening: 0- spontaneously, 1- on verbal stimulation, 2- on physical stimulation Adverse events: bradycardia, hypotension, respiratory depression, local anesthesia toxicity, subarachnoid injection in caudal block, PONV, agitation, or urinary catheterization.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Faces Legs Activity Cry Consolability tool (FLACC, 0- 10) at 15 min, 30 min and 1, 2, 3 and 4 h after operation

  4 hours

Secondary Outcomes (1)

• Analgesic effect of the block

  4 hours

Study Arms (3)

Group E

ACTIVE COMPARATOR

Ultrasound guided erector spinae block

Procedure: Erector Spinae (ESP) Block with Bupivacaine (Marcaine®)

Group C

ACTIVE COMPARATOR

Ultrasound guided caudal block

Procedure: Caudal Block Anesthesia

Group L

ACTIVE COMPARATOR

Local infiltration of the wound

Procedure: Local infiltration in the wound

Interventions

Local infiltration in the wound PROCEDURE

Local Infiltration Group will receive 0.2 ml/kg 0.25% bupivacaine

Group L

Erector Spinae (ESP) Block with Bupivacaine (Marcaine®) PROCEDURE

Group E (n=25): Erector spinae plain block group will receive 0.5 ml/kg of 0.25%bupivacaine.

Group E

Caudal Block Anesthesia PROCEDURE

Caudal block group will receive 1 ml/kg of 0.25% bupivacaine

Group C

Eligibility Criteria

• Age: 24 Months - 84 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• Parents refusal. Coagulopathy. Allergy to local anesthesia. Local infection at the site of injection. Neurological anomalies.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Mohamed Zakarea Wfa

Tanta, Tanta, +20, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Parapsychology; Dental Occlusion; Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisted professor

Model Details: Group E : erector spinae block ultrasound guided Group C: ultrasound guided caudal block Group L: local infiltration

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 27, 2025
• Study Start: January 20, 2025
• Primary Completion: June 10, 2025
• Study Completion: August 15, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

EG (1)