Incidence of Urethrocutaneous Fistula With and Without Caudal Epidural Block

Sponsor

Sir Ganga Ram Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03812731

Collaborator

(none)

Enrollment

Location

Arms

9.2

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Distal Hypospadias	Drug: Ropivacaine Drug: Fentanyl Citrate	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 22, 2019

Actual Primary Completion Date :

Nov 28, 2019

Actual Study Completion Date :

Nov 28, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of urethrocutaneous fistula [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 Outcome Measures

Penile Engorgement [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
Changes in intra-operative heart rate (beats per minute) [From beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively]
Comparison of intra-operative heart rate between both the arms will be done
Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg) [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
Postoperative analgesia requirement [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
Incidence of complications [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 8 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sir Ganga Ram Hospital	New Delhi	Delhi	India	110060

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Nitin Sethi, Associate Professor & Consultant, Sir Ganga Ram Hospital

ClinicalTrials.gov Identifier:

NCT03812731

Other Study ID Numbers:

EC/01/19/1478

First Posted:

Jan 23, 2019

Last Update Posted:

Oct 30, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 30, 2020