Incidence of Urethrocutaneous Fistula With and Without Caudal Epidural Block

• Status: Completed
• Trial end date: 2019-11-28
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sir Ganga Ram Hospital
• Treatments: Citric Acid; Fentanyl; Ropivacaine

Criteria

Inclusion Criteria:

1. Male children l

2. 1 to 8 years of age

3. ASA physical status I and II

4. Distal hypospadias -

Exclusion Criteria:

1. Simultaneously undergoing any other procedure

2. Local infection in sacral region

3. Bleeding diathesis

4. Preoperative testosterone stimulation