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CTRI Number  CTRI/2024/06/069437 [Registered on: 25/06/2024] Trial Registered Prospectively
Last Modified On: 14/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Patients undergoing renal transplant surgery will receive either quadratus lumborum block or erector spinae block for pain relief after surgery.  
Scientific Title of Study   A comparative evaluation of anterior quadratus lumborum block with erector spinae plane block in renal transplant recipient for post operative analgesia. 
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 Divesh Arora 
Designation  Director and HOD 
Affiliation  Asian Hospital Faridabad 
Address  Department of Anesthesia and OT services, 3rd floor, Asian Institute of medical sciences, Sector 21 A, badkal flyover road, Faridabad - 121002 HARYANA India Faridabad HARYANA 121002 India

Faridabad
HARYANA
121002
India 
Phone  9650099113  
Fax    
Email  drdivesh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Divesh Arora 
Designation  Director and HOD 
Affiliation  Asian Hospital Faridabad 
Address  Department of Anesthesia and OT services, 3rd floor, Asian Institute of medical sciences, Sector 21 A, badkal flyover road, Faridabad - 121002 HARYANA India Faridabad HARYANA 121002 India


HARYANA
121002
India 
Phone  9650099113  
Fax    
Email  drdivesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Divesh Arora 
Designation  Director and HOD 
Affiliation  Asian Hospital Faridabad 
Address  Department of Anesthesia and OT services, 3rd floor, Asian Institute of medical sciences, Sector 21 A, badkal flyover road, Faridabad - 121002 HARYANA India Faridabad HARYANA 121002 India


HARYANA
121002
India 
Phone  9650099113  
Fax    
Email  drdivesh@gmail.com  
 
Source of Monetary or Material Support  
Asian Institute of medical sciences, Sector 21 A, badkal flyover road, Faridabad - 121002  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Divesh Arora  Asian Hospital Faridabad  Department of anesthesia, 3rd floor, OT Complex, Asian Institute of medical sciences, Sector 21 A, badkal flyover road, Faridabad - 121002
Faridabad
HARYANA 		 9650099113

drdivesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE ASIAN HOSPITAL  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 
Intervention  Ultrasound guided anterior quadratus lumborum block.  Patients in this group will receive injection ropivacaine 0.3 % 25 mls with dexamethasone 8 mg under ultrasound guidance using 22 g needle. 
Comparator Agent  Ultrasound guided Thoracic Erector Spinae Plane block.  Patients in this group will receive injection ropivacaine 0.3 % 25 mls with dexamethasone 8 mg under ultrasound guidance using 22 g needle 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing renal transplant recipient surgery from live donor. 
 
ExclusionCriteria 
Details  1. Patient refusal.
2. Patients with features of local infection at the site of block.
3. Patients with history of bleeding disorder or on anticoagulant therapy.
4. Patients with known allergy to local anesthetic drugs.
5. Patients with mental illness.
6. Patients with neuromuscular disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Time of requirement of first rescue opioid analgesic.  during first 24 hours following surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
1 VAS score.
2 24-hour tramadol requirement.
3 24-hour fentanyl requirement.
4 Patient satisfaction score.
5 Side effects like nausea, vomiting and sedation.
 		 during first 24 hours following surgery. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 4 
Date of First Enrollment (India)   01/07/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Patients undergoing renal transplant recipient surgery have moderate pain. This study is designed to evaluate the efficacy of two regional analgesia techniques: anterior quadratus lumborum block and erector spinae plane block as a part of multimodal analgesia regime. 
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