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Trial record 46 of 117 for:    "Penile Disease"

Incidence of Urethrocutaneous Fistula With and Without Caudal Epidural Block

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ClinicalTrials.gov Identifier: NCT03812731
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Nitin Sethi, Sir Ganga Ram Hospital

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.

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 : February 22, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   1 Year to 8 Years   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only male patients with distal hypospadias will be included
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812731


Contacts
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Contact: Nitin Sethi, DNB 00919717494498 nitinsethi77@yahoo.co.in
Contact: Archna Koul, MD 00919958892622 archnakoul1@gmail.com

Locations
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India
Sir Ganga Ram Hospital Recruiting
New Delhi, Delhi, India, 110060
Contact: Nitin Sethi, DNB    00911142252523    nitinsethi77@yahoo.co.in   
Contact: Archna Koul, MD    00911142252523    archnakoul1@gmail.com   
Principal Investigator: Deepali Shukla, DA         
Principal Investigator: Archna Koul, MD         
Sub-Investigator: Nitin Sethi, DNB         
Sub-Investigator: Satish K Aggarwal, MS, MCH         
Sub-Investigator: Deepanjali Pant, MD         
Sub-Investigator: Abhjit S Pahwa, DNB         
Sub-Investigator: Jayashree Sood, MD,FFRCA         
Sponsors and Collaborators
Sir Ganga Ram Hospital
Investigators
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Principal Investigator: Deepali Shukla, DA Sir Ganga Ram Hospital
Study Director: Archna Koul, MS, MCH Sir Ganga Ram Hospital

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Responsible Party: Dr Nitin Sethi, Associate Professor & Consultant, Sir Ganga Ram Hospital
ClinicalTrials.gov Identifier: NCT03812731     History of Changes
Other Study ID Numbers: EC/01/19/1478
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Penile Diseases
Fistula
Hypospadias
Pathological Conditions, Anatomical
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Fentanyl
Ropivacaine
Citric Acid
Sodium Citrate
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action