MedDataX Logo

Incidence of Urethrocutaneous Fistula With and Without Caudal Epidural Block

NCT ID: NCT03812731

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-22

Study Completion Date

2019-11-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Distal Hypospadias

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Fentanyl Citrate

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ropivacaine

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

Intervention Type DRUG

Fentanyl Citrate

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

8 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sir Ganga Ram Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Nitin Sethi

Associate Professor & Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Deepali Shukla, DA

Role: PRINCIPAL_INVESTIGATOR

Sir Ganga Ram Hospital

Archna Koul, MS, MCH

Role: STUDY_DIRECTOR

Sir Ganga Ram Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EC/01/19/1478

Identifier Type: -

Identifier Source: org_study_id