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CTRI Number  CTRI/2022/09/045161 [Registered on: 01/09/2022] Trial Registered Prospectively
Last Modified On: 10/06/2023
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 study on Pain relief after surgery 
Scientific Title of Study   Efficacy of Transverse Abdominis Plane block for post operative analgesia in different lower abdominal surgeries in a tertiary care hospital – Chengalpattu District 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Murali Manoj 
Designation  Associate Professor 
Affiliation  Karpaga Vinayaga Institute of Medical Sciences and Research Centre 
Address  Department Of Anaesthesiology, Karpaga Vinayaga Institute of Medical Sciences and Research Centre, GST Road, Chinnakolampakkam,Maduranthagam Tk, Chengalpattu Dt
Department Of Anaesthesiology, GST Road, Chinnakolampakkam,Maduranthagam Tk, Chengalpattu Dt
Kancheepuram
TAMIL NADU
603308
India 
Phone  9791990979  
Fax    
Email  mmm.slazenger@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Murali Manoj 
Designation  Associate Professor 
Affiliation  Karpaga Vinayaga Institute of Medical Sciences and Research Centre 
Address  Department Of Anaesthesiology, Karpaga Vinayaga Institute of Medical Sciences and Research Centre, GST Road, Chinnakolampakkam,Maduranthagam Tk, Chengalpattu Dt
Department Of Anaesthesiology, GST Road, Chinnakolampakkam,Maduranthagam Tk, Chengalpattu Dt
Kancheepuram
TAMIL NADU
603308
India 
Phone  9791990979  
Fax    
Email  mmm.slazenger@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M Murali Manoj 
Designation  Associate Professor 
Affiliation  Karpaga Vinayaga Institute of Medical Sciences and Research Centre 
Address  Department Of Anaesthesiology, Karpaga Vinayaga Institute of Medical Sciences and Research Centre, GST Road, Chinnakolampakkam,Maduranthagam Tk, Chengalpattu Dt
Department Of Anaesthesiology, GST Road, Chinnakolampakkam,Maduranthagam Tk, Chengalpattu Dt
Kancheepuram
TAMIL NADU
603308
India 
Phone  9791990979  
Fax    
Email  mmm.slazenger@gmail.com  
 
Source of Monetary or Material Support  
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre 
 
Primary Sponsor  
Name  Dr M MURALI MANOJ 
Address  Associate Professor, Department Of Anaesthesiology, Karpaga Vinayaga Institute Of Medical Sciences and Research Centre, GST Road, Chinna Kolambakkam, Palayanoor Post, Maduranthakam Taluk, Chengalpattu District 
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 M Murali Manoj  Karpaga Vinayaga Institute of Medical Sciences & Research Centre  Department Of Anaesthesiology, GST Road, Chinna Kolambakkam, Palayanoor Post, Madhuranthakam Taluk,
Kancheepuram
TAMIL NADU 		 9791990979

mmm.slazenger@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee (Human Studies) Karpaga Vinayaga Institute Of medical Sciences and Research Centre  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard Analgesia  Standard Post operative Analgesia at 4,8,12,16,20,24 hrs 
Intervention  Transverse Abdominis Block  Efficacy of Transverse Abdominis Plane block post operatively at 4,8,12,16,20,24 hrs 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Elective lower abdominal surgery and expected duration of surgery 1 to 2 hrs 
 
ExclusionCriteria 
Details  Surgeries extend to the upper abdomen, maximum handling of visceral organs, delayed surgical procedures, intubation followed by failed by sub arachnoid blocks and unplanned intubations 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Post-operative pain relief in lower abdominal surgeries  30min,4hrs,8hrs,12hrs,16hrs,20hrs and 24hrs 
 
Secondary Outcome  
Outcome  TimePoints 
reduction in subsequent analgesic requirement usage, augments early mobilisation, discharge and cost effective too.  24hrs 
 
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)   15/09/2022 
Date of Study Completion (India) 01/02/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Anesthesiology and Pain Medicine 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The key factor to decide the outcome of a patient undergoing surgery is the post operative pain relief. Transverse abdominis plane block is one of the novel approach for blocking the abdominal wall afferents and thus it is an effective method in providing post operative analgesia in patients undergoing lower abdominal surgeries. In this study we will evaluate the efficacy of transverse abdominis plane block as a post operative analgesia in different lower abdominal surgeries. 
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