Skip to main content
Clinical Trials/CTRI/2023/09/058031
CTRI/2023/09/058031RecruitingPhase 3

Rates of urethrocutaneous fistula/ glans dehiscence among children undergoing urethroplasty under GA with caudal morphine and local anaesthetic or caudal morphine and normal saline.

FLUID RESEARCH FUND1 site in 1 country400 target enrollmentStarted: October 15, 2023Last updated:

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Sponsor
Enrollment
400
Locations
1
Primary Endpoint
Rates of urethrocutaneous fistula/ glans dehiscence

Study Overview

Brief Summary

Urethroplasty is a common procedure done for hypospadias in children with aim of providing a normal meatus at the tip for voiding. This procedure is done under general anaesthesia +/- caudal analgesia which takes care of the pain during and after the surgery.  Postoperatively when children are followed up, it is seen that some of the children have surgical complications like Urethrocutaneous fistula (UCF), glans dehiscence, meatal stenosis, etc.  Various studies have shown that caudal analgesia is associated with surgical complications like UCF and glanular dehiscence. In this prospective study, we are trying to see if caudal analgesia is directly associated with above mentioned surgical complications. Children who are diagnosed with hypospadias and will undergo urethroplasty will be included in the study. Consent will be taken from the parents after explaining the plan of Anaesthesia during surgery. Children will be randomly allocated into two different groups. Children of both the groups will be operated under General Anaesthesia. After randomisation, one set of children will get caudal analgesia with 0.2% Ropivacaine + 30mcg/kg  Caudal morphine and another set of children will get caudal analgesia with 0.9% NS + 30mcg/Kg Caudal morphine.

Study Design

Study Type
Interventional
Allocation
Stratified block randomization
Masking
Open Label

Eligibility Criteria

Ages
1.00 Year(s) to 16.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Children more than 1 year and less than age of 16 years
  • Primary urethroplasty.

Exclusion Criteria

  • 1.Staged procedures.
  • 2.Redo surgeries.
  • 3.Severe hypospadias (seen in DSD, CHD etc) 4.Children with contraindications for caudal analgesia like sepsis, local site infection, bleeding disorders, etc.
  • 5.Children less than 1 year.

Outcomes

Primary Outcomes

Rates of urethrocutaneous fistula/ glans dehiscence

Time Frame: 4-8 weeks post operatively.

Secondary Outcomes

  • 1.Intra operative penile girth measurement.(2.Peri-operative opioid requirement.)

Investigators

Sponsor
FLUID RESEARCH FUND
Sponsor Class
Private medical college

Study Sites (1)

Loading locations...

Similar Trials