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CTRI Number  CTRI/2022/12/048187 [Registered on: 16/12/2022] Trial Registered Prospectively
Last Modified On: 12/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Post operative pain relief comparison in children undergoing hypospadias repair using caudal epidural block and ultrasound guided pudendal nerve block  
Scientific Title of Study   COMPARISION OF ULTRASOUND GUIDED PUDENDAL NERVE BLOCK AND CAUDAL EPIDURAL BLOCK FOR POST OPERATIVE ANALGESIA IN CHILDREN UNDERGOING HYPOSPADIAS REPAIR. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pratibha Lakra 
Designation  Post graduate student 
Affiliation  Maulana Azad Medical College 
Address  Room No.303,3rd floor,BL Taneja Block, Department of Anaesthesiology,Maulana Azad Medical College
Room No.303,3rd floor,BL Taneja Block, Department of Anaesthesiology,Maulana Azad Medical College
Central
DELHI
110002
India 
Phone  8810208971  
Fax    
Email  lakrapratibha7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anju Romina Bhalotra 
Designation  Director Professor  
Affiliation  Maulana Azad Medical College 
Address  Room No. 303,3rd floor,BL Taneja Block,Department of Anaesthesiology,Maulana Azad Medical College
Room No. 303,3rd floor,BL Taneja Block,Department of Anaesthesiology,Maulana Azad Medical College
Central
DELHI
110002
India 
Phone  9968604219  
Fax    
Email  drakgk@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Pratibha Lakra 
Designation  Post graduate student 
Affiliation  Maulana Azad Medical College 
Address  Room No. 303,3rd floor,BL Taneja Block, Department of Anaesthesiology,Maulana Azad Medical College
Room No. 303,3rd floor,BL Taneja Block ,Department of Anaesthesiology, Maulana Azad Medical College
Central
DELHI
110002
India 
Phone  8810208971  
Fax    
Email  lakrapratibha7@gmail.com  
 
Source of Monetary or Material Support  
Lok Nayak Jai Prakash Narayan Hospital,Jawaharlal Nehru Marg,Maulana Azad Medical College Campus,Delhi Gate,New Delhi,110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College and Associated Hospital 
Address  JLN Marg,New Delhi,110002 
Type of Sponsor  Government 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 Pratibha Lakra  Maulana Azad Medical College  Room No.303 BL Taneja Block Department of Anaesthesiology
New Delhi
DELHI 		 8810208971

lakrapratibha7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee Maulana Azad Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: N488||Other specified disorders of penis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Caudal epidural block  For post-operative analgesia in children undergoing hypospadias repair,child will be given caudal epidural block under general anaesthesia with anticipated duration of surgery 1-2hour 
Intervention  Ultrasound guided pudendal nerve block  For post-operative analgesia in children undergoing hypospadias repair,child will be given usg-guided pudendal nerve block under general anaesthesia with anticipated duration of surgery 1-2 hour 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Male 
Details  1. Physical status ASA I-II.
2. Age of patient 2-12 years
3. Anticipated duration of surgery: 1-2 hour 
 
ExclusionCriteria 
Details  1. H/O growth retardation or mental disorder affecting pain score assessment
2. Patient or parent refusal for the block
3. Patients with bleeding and coagulation disorder
4. Patients with vertebral column abnormalities or any neurological disorders
5. Allergic to any drugs used in the study
6. Infection at injection site
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Percentage of patients requiring analgesia during the first 24 hours after surgery  12 MONTH 
 
Secondary Outcome  
Outcome  TimePoints 
• Pain scores (Modified Objective Pain Score)
• Postoperative analgesic consumption 		 12 MONTH 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   27/12/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  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 (Others) -  lakrapratibha7@gmail.com

  6. For how long will this data be available start date provided 17-07-2024 and end date provided 17-07-2027?
    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   Regional anaesthetic techniques are frequently used with general anaesthesia to manage intra and post-operative pain, reduce parenteral opioid requirement, and facilitate pain control during paediatric procedures. One of the most often used regional anaesthesia techniques in children is caudal epidural block (CEB). However, single injection CEB has a short duration of action and anatomical variations, and abnormalities may make administration of CEB challenging. Recently, peripheral nerve blocks are increasingly being employed for peri-operative analgesia when appropriate, as they have less risk of side effects as combined with neuraxial procedures. Also, the availability of ultrasound machines has made this easier and safer. Pudendal nerve block (PNB) is a peripheral nerve block that is frequently used to provide efficient pain control after penile surgery. A few previous studies have shown that PNB is effective for providing prolonged post operative analgesia.1,2 PNB can be accomplished utilising a landmark technique with transcutaneous use of a peripheral nerve stimulator or by ultrasonographic guidance (USG).2 Naja ZM et al compared effectiveness of PNB with CEB and found that the percentage of patients who received analgesics during the first 24 hours after hypospadias surgery was significantly higher in the CEB (70%) compared with the nerve stimulator guided PNB group (20%, p < 0.0001) and analgesic consumption was also higher in the CEB group.1 We decided to compare USG guided PNB with CEB for post operative analgesia in children undergoing hypospadias surgery. 
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