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CTRI Number  CTRI/2019/09/021219 [Registered on: 12/09/2019] Trial Registered Prospectively
Last Modified On: 12/09/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   STUDY TO SEE THE EFFECT OF ERECTOR SPINAE PLANE BLOCK AND QUADRATUS LUMBORUM BLOCK FOR PAIN RELEIF IN PATIENTS UNDERGOING RENAL TRANSPLANT OPERATION  
Scientific Title of Study   EFFICACY OF ERECTOR SPINAE PLANE BLOCK AND QUADRATUS LUMBORUM BLOCK FOR PERIOPERATIVE ANALGESIA IN PATIENTS SCHEDULED FOR RENAL TRANSPLANTATION - A SINGLE BLINDED RANDOMIZED CONTROLLED STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr GUDELA MOHAN SAI 
Designation  JUNIOR RESIDENT ( Postgraduate trainee) 
Affiliation  All India Institute of Medical Sciences 
Address  Room number 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care All India Institute of Medical Sciences Ansari Nagar New Delhi

New Delhi
DELHI
110029
India 
Phone  9599086268   
Fax    
Email  gudelamohansai.007@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Virender Kumar Mohan 
Designation  Professor  
Affiliation  All India Institute of Medical Sciences  
Address  Room number 5011, Teaching block, Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9891557705  
Fax    
Email  dr_vkmohan@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Virender Kumar Mohan 
Designation  Professor  
Affiliation  All India Institute of Medical Sciences  
Address  Room number 5011, Teaching block, Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi

North East
DELHI
110029
India 
Phone  9891557705  
Fax    
Email  dr_vkmohan@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences  
Address  Room number 5011, Teaching block, Deparytment of Anesthesiology, Pain Medicine and Critical care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110029 
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 Gudela Mohan Sai  All India Institute of Medical Sciences   Room number 5011, Department of Anesthesiology, Pain Medicine and Critical care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029
New Delhi
DELHI 
9599086268

gudelamohansai.007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee for postgraduate research, AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Erector Spinae Plane Block  30ml of 0.375% Ropivacaine injection is utilised for USG guided ipsilateral Erector spinae plane block 
Comparator Agent  Neither Erector spinae plane block nor Quadratus lumborum block   Patients will receive only perioperative intraoperative analgesics according to standard dosing 
Intervention  Quadratus lumborum block   30ml of 0.375% Ropivacaine injection is utilised for USG guided ipsilateral Quadratus lumborum block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing renal transplantation under General Anesthesia  
 
ExclusionCriteria 
Details  1. Patient refusal to participate
2. Known hypersensitivity to local anaesthetic drug
3. Patient having infection at site of block
4. Patient having spinal Deformity and previous history
5. Patients on anti coagulants
6. Patients with untreated psychiatric illness 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Compare perioperative fentanyl consumption between Erector spinae plane block group, Quadratus lumborum block group and control group in patients undergoing renal transplantation over a period of 24 hours after surgery   Intraoperative time plus postoperative follow up of 24 hours  
 
Secondary Outcome  
Outcome  TimePoints 
Pain scores using numerical rating scale, time for first rescue analgesic and incidence of postoperative nausea and vomiting between Erector spinae plane block group, Quadratus lumborum block group and control group in patients undergoing renal transplantation surgery over a period of 24 hours  Intraoperative time plus postoperative follow up of 24 hours  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 2 
Date of First Enrollment (India)   20/09/2019 
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="2"
Months="2"
Days="2" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a randomised single blinded study to compare perioperative analgesic efficacy of Erector spinae plane block and Quadratus lumborum block in patients undergoing renal transplantation  
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