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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 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-01-16

No results posted yet for this study

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

Interventions

PROCEDURE

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

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

PROCEDURE

Caudal Block Anesthesia

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

PROCEDURE

Local infiltration in the wound

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

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
84 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2025-06-10
Completion
2025-08-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06849804 on ClinicalTrials.gov