Incidence of Urethrocutaneous Fistula With and Without Caudal Epidural Block

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

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.

Study Overview

• Status: Completed
• Conditions: Distal Hypospadias
• Intervention / Treatment: Drug: Ropivacaine; Drug: Fentanyl Citrate

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110060
      • Sir Ganga Ram Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Caudal Group; Children will receive oral midazolam 0.25 mg/kg thirty minutes before induction. Inhalational induction will be carried with incremental concentration of sevoflurane upto 8% in 50% oxygen and nitrous oxide mixture. As soon as the child will be asleep, ASA standard monitors (SPO2, HR, ECG and NIBP) will be attached. Intravenous access with age appropriate IV cannula will be secured. Injection fentanyl citrate 2 mcg/ kg followed by injection atracurium 0.5 mg/kg will be administered. Appropriate size LMA Pro SealTM will be inserted and pressure controlled ventilation will be instituted. Children in will then receive CEB with 0.2 % ropivacaine 1-ml/kg for maintaining analgesia	Drug: Ropivacaine; Intraoperatively after induction of anaesthesia caudal epidural block will be administered with 0.2% ropivacaine 1-ml/kg
ACTIVE_COMPARATOR: Non- Caudal Group; Children will receive oral midazolam 0.25 mg/kg thirty minutes before induction. Inhalational induction will be carried with incremental concentration of sevoflurane upto 8% in 50% oxygen and nitrous oxide mixture. As soon as the child will be asleep, ASA standard monitors (SPO2, HR, ECG and NIBP) will be attached. Intravenous access with age appropriate IV cannula will be secured. Injection fentanyl citrate 2-mcg/ kg followed by injection atracurium 0.5 mg/kg will be administered. Appropriate size LMA Pro SealTM will be inserted and pressure controlled ventilation will be instituted. Children in will then receive fentanyl citrate 1-mcg/kg/hr for maintaining analgesia	Drug: Fentanyl Citrate; Intraoperatively after induction of anaesthesia fentanyl 1-mcg/kg/hour will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of urethrocutaneous fistula	Patients undergoing distal hypospadias repair will be followed up for occurrence of uretherocutaneous fistula	From one day after surgery(0-hours, baseline) till 3-months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penile Engorgement	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	After induction of anaesthesia (0-hours, baseline) till end of surgery
Changes in intra-operative heart rate (beats per minute)	Comparison of intra-operative heart rate between both the arms will be done	From beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively
Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg)	Comparison of intra-operative blood pressure- systolic, diastolic, and mean between both the arms will be done	rom beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively
Postoperative analgesia requirement	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	From end of anaesthesia (0-hours, baseline) till 24-hours postoperatively
Incidence of complications	Complications of surgery such as infection, bleeding , hematoma, glans dehiscence, skin or flap necrosis will be noted	From end of anaesthesia (0-hours, baseline) till 3-months postoperatively

Collaborators and Investigators

• Sponsor: Sir Ganga Ram Hospital
• Investigators: Principal Investigator: Deepali Shukla, DA, Sir Ganga Ram Hospital; Study Director: Archna Koul, MS, MCH, Sir Ganga Ram Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 22, 2019
• Primary Completion (ACTUAL): November 28, 2019
• Study Completion (ACTUAL): November 28, 2019

Study Registration Dates

• First Submitted: January 19, 2019
• First Submitted That Met QC Criteria: January 19, 2019
• First Posted (ACTUAL): January 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Pathological Conditions, Anatomical; Penile Diseases; Fistula; Hypospadias; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Ropivacaine
• Other Study ID Numbers: EC/01/19/1478

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No