Comparison of Two Pain Relief Methods for Surgeries in Children

Comparative Evaluation of the Effectiveness of Ultrasound-Guided Lumbar Erector Spinae Plane Block and Caudal Epidural Block for Postoperative Analgesia in Pediatric Inguinal Hernia Surgeries: A Randomised Noninferiority Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/07/113827

Enrollment

Registered

2026-07-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: K409- Unilateral inguinal hernia, without obstruction or gangrene

Interventions

Intervention1: Ultrasound-guided Lumbar Erector Spinae Plane Block: Pre-operative Ultrasound-guided Lumbar Erector Spinae Plane block administered to Pediatric patients undergoing Unilateral Inguinal

Eligibility

Inclusion criteria

Inclusion criteria: Patients of American Society of Anaesthesiologists Physical Status I and II aged from 6 months to 7 years scheduled for elective unilateral Inguinal hernia repair

Exclusion criteria

Exclusion criteria: History of clinically significant cardiac, hepatic, renal, or neurological conditions. Known allergy to amide Local anaesthetics.Local infection at injection sites. Coagulation abnormalities.

Design outcomes

Primary

Measure	Time frame
To assess non-inferiority of the mean duration of analgesiaTimepoint: The time to first analgesic request at FLACC score 4	—

Secondary

Measure	Time frame
Comparing the analgesic effect of Caudal epidural block & Erector Spinae Plane block by Mean FLACC pain scores in both study groupsTimepoint: At 0 minute, 30 minutes,1 hour, 2 hours, 4 hours, 8 hours, 12 hours, & 24 hours postoperatively;Total postoperative analgesic consumption & time to first rescue analgesia in both study groupsTimepoint: From 1 to 24 hours following Inguinal hernia surgery;Mean changes in hemodynamic parameters including Heart rate & Mean Arterial Pressure in both study groupsTimepoint: Baseline intraooperatively & at 0 minute,30 minute, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours postoperatively;Mean parental satisfaction score & percentage of patients experiencing adverse events & complications in both study groupsTimepoint: At 24 hours postoperatively	—

Measure

Time frame

Comparing the analgesic effect of Caudal epidural block & Erector Spinae Plane block by Mean FLACC pain scores in both study groupsTimepoint: At 0 minute, 30 minutes,1 hour, 2 hours, 4 hours, 8 hours, 12 hours, & 24 hours postoperatively;Total postoperative analgesic consumption & time to first rescue analgesia in both study groupsTimepoint: From 1 to 24 hours following Inguinal hernia surgery;Mean changes in hemodynamic parameters including Heart rate & Mean Arterial Pressure in both study groupsTimepoint: Baseline intraooperatively & at 0 minute,30 minute, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours postoperatively;Mean parental satisfaction score & percentage of patients experiencing adverse events & complications in both study groupsTimepoint: At 24 hours postoperatively

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Countries

India

Contacts

Public ContactDr Ankita Sankhala

ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR

ankusnkhl@gmail.com8982436852

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026