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NCT Number: NCT03812731

Incidence of Urethrocutaneous Fistula With and Without Caudal Epidural Block

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.

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Key information

Conditions

Distal Hypospadias

Age range

1 year–8 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

About this study

CEB is routinely used along with general anaesthesia for inguinal and genital surgeries. It provides intraoperative and postoperative analgesia, is safe, simple and has success rate of more than 90% in children.It decreases the requirement of inhalational anaesthetics and narcotics, decreases stress hormone release and facilitates early recovery. Hypospadias is the most common congenital anomaly of penis, incidence being 1 in 300 live births. Hypospadias repair is a technical procedure that can be associated with significant complications such as meatal stenosis, stricture, glans dehiscence and flap necrosis Urethrocutaneous fisula formation is the most common complication after primary repair with an incidence of upto 20%. There have been controversies regarding the association of CEB with urethrocutaneous fistula. Some studies have reported a high incidence of postoperative urethrocutaneous fistula in children who received CEB while others have not confirmed any such relationship. Association between urethrocutaneous fistula and site of urethral opening, age of patient, duration of surgery, surgeon's expertise, use of subcutaneous epinephrine and use of preoperative testosterone has been found. Penile engorgement, post inflammatory response and tissue oedema may be contributory factors for development of fistula. However any association between CEB and fistula formation is not clear. All studies, except one, are retrospective, limited by small sample size and presence of various confounding factors. The present study is aimed to explore any association between CEB and urethrocutaneous fistula. The study will be conducted in children with distal hypospadias only; they will be operated by a single surgeon, without the use of subcutaneous epinephrine, so that any association, if at all between CEB and urethrocutaneous fistula becomes evident.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male children l
  • 1 to 8 years of age
  • ASA physical status I and II
  • Distal hypospadias -

Exclusion criteria

  • Simultaneously undergoing any other procedure
  • Local infection in sacral region
  • Bleeding diathesis
  • Preoperative testosterone stimulation

Treatment and study plan

Ropivacaine

Drug

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

Fentanyl Citrate

Drug

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

Primary outcomes

  1. Incidence of urethrocutaneous fistula

    Time frame: From one day after surgery(0-hours, baseline) till 3-months post surgery

    Patients undergoing distal hypospadias repair will be followed up for occurrence of uretherocutaneous fistula

Secondary outcomes

  1. Penile Engorgement

    Time frame: After induction of anaesthesia (0-hours, baseline) till end of surgery

    Length of penis from pubic bone to glans tip and mid shaft circumference i.e. girth around the widest part of the penile shaft will be calculated

  2. Changes in intra-operative heart rate (beats per minute)

    Time frame: From beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively

    Comparison of intra-operative heart rate between both the arms will be done

  3. Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg)

    Time frame: rom beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively

    Comparison of intra-operative blood pressure- systolic, diastolic, and mean between both the arms will be done

  4. Postoperative analgesia requirement

    Time frame: From end of anaesthesia (0-hours, baseline) till 24-hours postoperatively

    Additional fentanyl citrate 0.5-mcg/kg will be administered intravenously if the Face, Legs, Activity, Cry, Consolability scale (FLACC scale) score is > 3 and total amount administered will be recorded

  5. Incidence of complications

    Time frame: From end of anaesthesia (0-hours, baseline) till 3-months postoperatively

    Complications of surgery such as infection, bleeding , hematoma, glans dehiscence, skin or flap necrosis will be noted

Sponsors and collaborators

Lead sponsor

Sir Ganga Ram Hospital

Other

Registry information

Official study title

Incidence of Urethrocutaneous Fistula Following Distal Hypospadias Repair With and Without Caudal Epidural Block - A Pilot Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2019
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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