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Incidence of Urethrocutaneous Fistula With and Without Caudal Epidural Block

NCT03812731 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-10-30

No results posted yet for this study

Summary

The study is designed to explore any association between the caudal epidural block(CEB) given for perioperative analgesia and the occurrence of urethrocutaneous fistula postoperatively in children undergoing distal hypospadias repair .We also intend to study the duration of penile engorgement due to CEB causing penile oedema which may subsequently play a role in fistula formation. The pilot study will recruit children under 8 years of age diagnosed with distal hypospadias scheduled to undergo Tubularised Incised Plate Urethroplasty, operated by a single paediatric surgeon. General anaesthesia will be induced with sevoflurane in oxygen nitrous oxide mixture supplemented by fentanyl citrate and atracurium besylate in all children. LMA Pro SealTMof appropriate size will be inserted. Children in group I will then be given caudal epidural block (CEB) as per our practice protocol. Children in group II will be given additional intravenous fentanyl citrate. All children will be followed postoperatively till 3 months to evaluate incidence of urethtocutaneous fistula. The prospective study attempts to eliminate previously reported confounding factors.

Conditions

  • Distal Hypospadias

Interventions

DRUG

Ropivacaine

Intraoperatively after induction of anaesthesia caudal epidural block will be administered with 0.2% ropivacaine 1-ml/kg

DRUG

Fentanyl Citrate

Intraoperatively after induction of anaesthesia fentanyl 1-mcg/kg/hour will be administered

Sponsors & Collaborators

  • Sir Ganga Ram Hospital

    lead OTHER

Principal Investigators

  • Deepali Shukla, DA · Sir Ganga Ram Hospital

  • Archna Koul, MS, MCH · Sir Ganga Ram Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
8 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-22
Primary Completion
2019-11-28
Completion
2019-11-28

Countries

  • India

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 NCT03812731 on ClinicalTrials.gov