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CTRI Number  CTRI/2023/08/057024 [Registered on: 29/08/2023] Trial Registered Prospectively
Last Modified On: 29/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of surgical complications followed by penile surgery in male children after caudal nerve block vs penile nerve block  
Scientific Title of Study   Comparison of ultrasound-guided pudendal nerve block (PNB) versus caudal epidural block (CEB) on surgical outcomes in children undergoing hypospadias surgery: a parallel arm randomized control study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr JOTHIMAI D T 
Designation  JUNIOR RESIDENT ACADEMIC 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar. 
Address  All India Institute of Medical Sciences, Room no:406, Academic building, Department of Anesthesiology and Critical Care, Sijua,Patrapada,Khordha, Orissa

Khordha
ORISSA
751019
India 
Phone  8838988763  
Fax  -  
Email  jothimaidt@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bikram Kishore Behera 
Designation  Additional professor 
Affiliation  All India Institute of Medical Sciences,Bhubaneswar 
Address  All India Institute of Medical Sciences, Room no:406, academic building, Department of Anesthesiology and Critical Care, Sijua,Patrapada,Khordha, Orissa

Khordha
ORISSA
751019
India 
Phone  9438884047  
Fax  -  
Email  anaes_bikram@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Bikram Kishore Behera 
Designation  Additional professor 
Affiliation  All India Institute of Medical Sciences,Bhubaneswar 
Address  All India Institute of Medical Sciences, Room no:406, academic building, Department of Anesthesiology and Critical Care, Sijua,Patrapada,Khordha, Orissa

Khordha
ORISSA
751019
India 
Phone  9438884047  
Fax  -  
Email  anaes_bikram@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bhubaneswar, Sijua, Patrapada, Khordha, Orissa-751019  
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Bhubaneswar 
Address  Sijua,Patrapada,Khordha, Orissa- 751019  
Type of Sponsor  Research institution and hospital 
 
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 JOTHIMAI D T  All India Institute of Medical Sciences, Bhubaneswar   Room no:406, Academic building, Department of Anesthesiology and Critical Care, Sijua,Patrapada,Khordha, Orissa
Khordha
ORISSA 		 8838988763
-
jothimaidt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, All India Institute of Medical Sciences, Bhubaneswar.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ultrasound guided caudal epidural block (CEB)   Ultrasound guided caudal epidural block will be given with 0.25% bupivacaine at a dose of 0.5ml/kg according to modified Armitage regimen 
Intervention  Ultrasound guided pudendal nerve block   Ultrasound guided anterior approach pudendal nerve block will be given with 0.25% bupivacaine at a dose of 0.25ml/kg on each side 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Male 
Details  1.ASA grade I and II patients
2.Male children aged between 03years -12 years of age scheduled for hypospadias repair.
 
 
ExclusionCriteria 
Details  1.Children with a bleeding disorder
2.Redo urethroplasty
3.Contraindication to CEB
4.Vertebral column anomaly
5.Neurological disorders
6.Refusal of the parents for regional blocks

 
 
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 
To report post-operative surgical complications such as
Urethrocutaneous fistula,
Wound dehiscence, Wound infection, Skin necrosis, Flap necrosis
 		 The duration of follow-up shall be till 14 days or up to the removal of the urinary catheter, whichever is earliest. Reporting of any one or more of these complications by the operating surgeon, shall be recorded as “Yes” & if none of them are reported shall be recorded as “No
 
 
Secondary Outcome  
Outcome  TimePoints 
Modified objective pain scores (MOPS) on arrival in the post-anesthesia care unit, 2,6,12,24 & 48 hours after surgery, Time to administration first rescue analgesia, The total dose and number of rescue analgesia (Inj. Tramadol) required in the first 48 hours of surgery.
 		 duration will be upto 48hours after surgery 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   04/09/2023 
Date of Study Completion (India) 20/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

General anesthesia along with caudal epidural block (CEB) is commonly used in children undergoing hypospadias surgery.Significant increase in the incidence of urethrocutaneous fistula have been reported by many studies in children who underwent hypospadias surgery.CEB results in the sympathetic blockade, venous pooling & penile engorgement. This may influence the quality of repair & impaired wound healing. Thus, may lead to an increased incidence of urethrocutaneous fistula along with other negative surgical outcomes. Pudendal nerve block (PNB) provides analgesia for perineum and external genitalia surgery. PNB has no sympathetic blockade like that of CEB.Hence this study aims to find out whether PNB shall result in lesser postoperative surgical complications in children undergoing hypospadias surgery as compared to CEB.

 
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