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Comparison of Post-surgery versus Pre-surgery caudal nerve block on surgical outcomes in children undergoing hypospadias surgery

Comparison of Post-surgical versus Pre-surgical caudal block on surgical outcomes in children undergoing hypospadias repair:A Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/066219
Enrollment
50
Registered
2024-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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: Post-surgical caudal block: Caudal block given at end of surgery, before awakening. 0.2% Ropivacaine (1ml/kg) Control Intervention1: Pre-surgical caudal block: Conventional caudal bloc

Sponsors

AIIMS Rishikesh, Uttrakhand
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male child:Aged 1-8 years ASA I and II children undergoing hypospadias repair surgery

Exclusion criteria

Exclusion criteria: skin infection or abscess at the side of caudal injection parents disagreement / refusal to consent patients having coagulopathy / on anticoagulants known allergy to any local anaesthetics children with neuromuscular disorders spinal dysraphism(meningomyelocele/sacral dimples) mental retardation/delayed development

Design outcomes

Primary

MeasureTime frame
Overall incidence of the following surgical complications: Urethro-cutaneous fistula, Local skin necrosis, Wound infection, Hematoma, Glans dehiscence and urethral strictureTimepoint: Post operative: Day 5, Day 10, 1 month and 6 months

Secondary

MeasureTime frame
Duration of post-operative analgesiaTimepoint: Post operative, the time to first rescue analgesic requirement at a FLACC score more than 5 or Visual Analogue Score corresponding to Numerical rating scale of more than 5 (in older children).;Intra-operative blood lossTimepoint: At the end of surgery;Intra-operative increase in penile volumeTimepoint: 0,10,15 & 30 minutes post induction of anesthesia;Surgery durationTimepoint: End of surgery;Surgery revision rate (requirement of re-surgery)Timepoint: Ascertained at 1 & 6 months post operative;Surgical stress response [blood glucose, by point of care glucometer]Timepoint: 0,30,60 & 90 minutes post induction

Countries

India

Contacts

Public ContactDr Osharani Rathor

All India Institute of Medical Sciences Rishikesh

mriduldhar8@hotmail.com9717778374

Outcome results

None listed

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