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CTRI Number  CTRI/2018/05/013802 [Registered on: 11/05/2018] Trial Registered Retrospectively
Last Modified On: 03/05/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to compare the effects of two ultrasound guided procedures i.e ilioinguinal and iliohypogastric nerve block with that of transversus abdominis plane block for patients undergoing inguinal hernia surgeries. 
Scientific Title of Study   Comparison of efficacy of ultrasound guided transversus abdominis plane block with ultrasound guided ilioinguinal and iliohypogastric nerve block for postoperative management in patients undergoing inguinal herniorrhaphy under spinal anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepa Chandran 
Designation  Assistant professor 
Affiliation  Sapthagiri Institute of Medical Sciences 
Address  4th floor,department of anaesthesia, sapthagiri institute of medical sciences, #15 chikkasandra, Hesarghatta main road,Bangalore
#15. Chikkasandra, Hesarghatta main road, Bangalore 560090
Bangalore
KARNATAKA
560090
India 
Phone  09945063487  
Fax    
Email  deepachandran@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepa Chandran 
Designation  Assistant professor 
Affiliation  Sapthagiri Institute of Medical Sciences 
Address  4th floor, department of anaesthesia,sapthagiri institute of medical sciences,#15, Chikkasandra, Hesarghatta main road,Bangalore
#15. Chikkasandra, Hesarghatta main road, Bangalore 560090
Bangalore
KARNATAKA
560090
India 
Phone  09945063487  
Fax    
Email  deepachandran@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepa Chandran 
Designation  Assistant professor 
Affiliation  Sapthagiri Institute of Medical Sciences 
Address  4th floor, department of anaesthesia ,sapthagiri institute of medical sciences,#15 Chikkasandra, Hesarghatta main road, Bangalore
#15. Chikkasandra, Hesarghatta main road, Bangalore 560090
Bangalore
KARNATAKA
560090
India 
Phone  09945063487  
Fax    
Email  deepachandran@rediffmail.com  
 
Source of Monetary or Material Support  
Sapthagiri Institute of Medical Sciences 
 
Primary Sponsor  
Name  Dr Deepa Chandran 
Address  #58, Ninaada, R K Enclave, 1st main, 2nd cross, Shetty halli,Bangalore 560015 
Type of Sponsor  Other [self] 
 
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 Deepa Chandran  sapthagiri institute of medical sciences  4th floor,department of anaesthesia,#15 chikkasandra Hesarghatta main road, bangalore 560090
Bangalore
KARNATAKA 		 09945063487

deepachandran@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sapthagiri institute of medical sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients undergoing inguinal hernia surgeries with ASA Grade 1 or 2 risk,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ultrasound guided ilioinguinal and iliohypogastric nerve block  ultrasound guided ilioinguinal and iliohypogastric nerve block is given to patients undergoing inguinal hernia surgeries under spinal anaesthesia postoperatively 
Comparator Agent  ultrasound guided transversus abdominis plane block  ultrasound guided transversus abdominis plane block is given to patients undergoing inguinal hernia surgeries under spinal anaesthesia postoperatively 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  having ASA class 1 and 2,scheduled for elective single sided ingunal herniorrhaphy operation 
 
ExclusionCriteria 
Details  under 18 years of age, patient refusal, having ASA 3 or 4 physical status score preoperatively, having one of the contraindications to spinal anasesthesia as listed by NYSORA( Newyork school of regional anaesthesia) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the postoperative analgesia following ultrasound guided TAP block with that of ultrasound guided ilioinguinal and iliohypogastric nerve block in patients undergoing inguinal hernia repair under spinal anaesthesia using visual analogue scale for pain assessment  1/8/2017 to 1/2/2018 
 
Secondary Outcome  
Outcome  TimePoints 
To study the adverse effects namely nausea and vomitting.  1/8/2017 to 1/2/2018 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2017 
Date of Study Completion (India) 01/02/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The primary purpose of this study is to study two different types of ultrasound guided blocks after spinal anaesthesia for patients undergoing inguinal hernia surgeries.This is done by analysing the visual analogue scores for pain assessment postoperatively.  
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