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A study comparing ultrasound and formula methods to decide the right amount of medicine for a caudal pain-relief injection in children during surgery

Comparison of Ultrasound-Guided and Formula-Based Volume Determination for Caudal Block Analgesia in Pediatric Patients: A Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/098197
Enrollment
80
Registered
2025-11-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Interventions

Intervention1: Ultrasound Guided Caudal Epidural Block: Caudal block performed under real-time ultrasound guidance using a high-frequency linear probe to identify the sacral hiatus and visualise drug

Sponsors

AKANKSHA TYAGI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pediatric patients of either Gender aged between 1 and 6 years American Society of Anaesthesiologists (ASA) physical status I, II Patients undergoing infra-umbilical surgery

Exclusion criteria

Exclusion criteria: Refusal to participate Allergy to local anaesthetic Coagulopathy Infection at the injection site Lumbosacral deformity Neurological disorders (e.g., cerebral palsy, developmental delay affecting sensory/motor assessment)

Design outcomes

Primary

MeasureTime frame
Volume of 0.25% Ropivacaine (mL) required to achieve sensory block up to T10 dermatome level.Timepoint: Assessed intra-operatively at the time of caudal block administration from needle insertion to completion of drug injection (approximately 0 6 minutes).

Secondary

MeasureTime frame
Post-operative pain using FLACC (Face, Legs, Activity, Cry, Consolability) scoreTimepoint: Postoperatively at 5, 10, 15, 20, 25, and 30 minutes, and then hourly up to 24 hours;Maximum sensory block level achievedTimepoint: Within 30 minutes after caudal block, tested by response to cold stimulus using spirit-soaked cotton; absence of response recorded as level of sensory block.;Incidence of adverse effects (hypotension, bradycardia, motor weakness, urinary retention, local anaesthetic toxicity)Timepoint: intraoperative and up to 24 hours postoperatively;Motor block assessment using Modified Bromage ScaleTimepoint: Every 5 minutes up to 30 minutes post-block;Duration of Post-operative AnalgesiaTimepoint: Duration of Analgesia from completion of block until first rescue analgesia ( when FLACC score is more than or equal to 4)

Countries

India

Contacts

Public ContactProf Dr Yashwant Singh Payal

All India Institute of Medical Sciences, Rishikesh

yashwant.anaes@aiimsrishikesh.edu.in9411789762

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026