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CTRI Number  CTRI/2023/09/058031 [Registered on: 26/09/2023] Trial Registered Prospectively
Last Modified On: 25/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Association between complications of urethroplasty surgery and the regional anaesthesia given for it.  
Scientific Title of Study   Rates of urethrocutaneous fistula/ glans dehiscence among children undergoing urethroplasty under GA with caudal morphine and local anaesthetic or caudal morphine and normal saline. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  INDLA JOSEPH VINEETH 
Designation  JUNIOR RESIDENT 
Affiliation  CHRISTIAN MEDICAL COLLEGE, VELLORE 
Address  INDLA JOSEPH VINEETH PAUL, Department of Anaesthesia, Unit - 5, Christian Medical College Hospital.

Vellore
TAMIL NADU
632004
India 
Phone  8056863072  
Fax    
Email  josephvineeth962@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anita Shirley  
Designation  Professor  
Affiliation  CHRISTIAN MEDICAL COLLEGE, VELLORE 
Address  Dr. ANITA SHIRLEY, DEPARTMENT OF ANAESTHESIA, CHRISTIAN MEDICAL COLLEGE, VELLORE - 632004, TAMIL NADU.

Vellore
TAMIL NADU
632004
India 
Phone  7358377164  
Fax    
Email  anjeyanth@gmail.com  
 
Details of Contact Person
Public Query  
Name  INDLA JOSEPH VINEETH 
Designation  JUNIOR RESIDENT 
Affiliation  CHRISTIAN MEDICAL COLLEGE, VELLORE 
Address  INDLA JOSEPH VINEETH PAUL, Department of Anaesthesia, Unit - 5, Christian Medical College Hospital.


TAMIL NADU
632004
India 
Phone  8056863072  
Fax    
Email  josephvineeth962@gmail.com  
 
Source of Monetary or Material Support  
Christian medical college hospital, Vellore.  
 
Primary Sponsor  
Name  FLUID RESEARCH FUND 
Address  CHRISTIAN MEDICAL COLLEGE AND HOSPITAL, VELLORE , TN - 632004 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR INDLA JOSEPH VINEETH PAUL  CHRISTIAN MEDICAL COLLEGE, VELLORE  Department of Anaesthesiology,Unit - 5,Paediatric Anaesthesiology, CB THEATRE - 1,2
Vellore
TAMIL NADU 		 8056863072

josephvineeth962@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RESEARCH AND ETHICS COMMITTEE, CMC VELLORE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N489||Disorder of penis, unspecified, (2) ICD-10 Condition: N488||Other specified disorders of penis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.2% Ropivacaine and morphine  0.2% Ropivacaine and 30mcg/kg morphine in epidural or caudal space 
Intervention  Morphine  30mcg/kg morphine and normal saline in caudal or epidural space 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1. Children more than 1 year and less than age of 16 years
2. Primary urethroplasty. 
 
ExclusionCriteria 
Details  1.Staged procedures.
2.Redo surgeries.
3.Severe hypospadias (seen in DSD, CHD etc)
4.Children with contraindications for caudal analgesia like sepsis, local site infection, bleeding disorders, etc.
5.Children less than 1 year 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Rates of urethrocutaneous fistula/ glans dehiscence  4-8 weeks post operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Intra operative penile girth measurement.
2.Peri-operative opioid requirement.
3. Post-operative pain scores.
4.Evaluation for chronic pain 		 Immediately intraop - penile girth
Post operative days 2-3 for peri operative opioid used & pain scores
8 weeks to 6 months for chronic pain.  
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/10/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/10/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [josephvineeth962@gmail.com].

  6. For how long will this data be available start date provided 10-02-2023 and end date provided 10-02-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Urethroplasty is a common procedure done for hypospadias in children with aim of providing a normal meatus at the tip for voiding. This procedure is done under general anaesthesia +/- caudal analgesia which takes care of the pain during and after the surgery.  Postoperatively when children are followed up, it is seen that some of the children have surgical complications like Urethrocutaneous fistula (UCF), glans dehiscence, meatal stenosis, etc.  Various studies have shown that caudal analgesia is associated with surgical complications like UCF and glanular dehiscence. In this prospective study, we are trying to see if caudal analgesia is directly associated with above mentioned surgical complications. Children who are diagnosed with hypospadias and will undergo urethroplasty will be included in the study. Consent will be taken from the parents after explaining the plan of Anaesthesia during surgery. Children will be randomly allocated into two different groups. Children of both the groups will be operated under General Anaesthesia. After randomisation, one set of children will get caudal analgesia with 0.2% Ropivacaine + 30mcg/kg  Caudal morphine and another set of children will get caudal analgesia with 0.9% NS + 30mcg/Kg Caudal morphine.

 
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