Incidence of Urethrocutaneous Fistula With and Without Caudal Epidural Block

NCT03812731 | Completed DMC

• 1 other identifier: EC/01/19/1478
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Penile Engorgement

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

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

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

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

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

• Postoperative analgesia requirement

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

• Incidence of complications

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

Study Arms (2)

Caudal Group

ACTIVE COMPARATOR

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

Non- Caudal Group

ACTIVE COMPARATOR

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

Interventions

Ropivacaine DRUG

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

Caudal Group

Fentanyl Citrate DRUG

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

Non- Caudal Group

Eligibility Criteria

• Age: 1 Year - 8 Years
• Gender Eligibility Details: Only male patients with distal hypospadias will be included
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (1)

Sir Ganga Ram Hospital

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

Location

MeSH Terms

Interventions

Ropivacaine; Fentanyl

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Deepali Shukla, DA

  Sir Ganga Ram Hospital

  PRINCIPAL INVESTIGATOR

• Archna Koul, MS, MCH

  Sir Ganga Ram Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The attending anaesthesiologist will not be blinded to the technique utilised to administer GA. An independent assessor blinded to the technique of GA will follow up the patients to determine the incidence of uretherocutaneous fistula
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor & Consultant

Model Details: 30 male patients aged 1-8 years, ASA physical status I/II, and undergoing distal hypospadias repair will be randomly allocated to one of the following two groups: GROUP I- (Caudal group, n= 15) Children will receive general anesthesia (GA) and analgesia will be maintained with caudal epidural block (CEB) with 0.2% ropivacaine:1 ml/kg. GROUP II- (Non-caudal group, n= 15) Children will receive general anaesthesia (GA) and analgesia will be maintained with intravenous fentanyl citrate 1mcg/kg/hr. roup-1 \[CLADS Group, n=60\]: Anaesthesia will be induced and maintained with propofol administered using the BIS feedback-based automated CLADS. Group-2 \[Desflurane Group, n=60\]: Anaesthesia will be induced with propofol CLADS and will be maintained intraoperatively by Desflurane titrated to BIS monitoring.

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: January 23, 2019
• Study Start: February 22, 2019
• Primary Completion: November 28, 2019
• Study Completion: November 28, 2019
• Last Updated: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)