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CTRI Number  CTRI/2024/04/066139 [Registered on: 23/04/2024] Trial Registered Prospectively
Last Modified On: 20/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing safety and efficacy of Erector Spinae Plane Block vs Quadratus Lumborum Block in patients undergoing PCNL surgery 
Scientific Title of Study   Comparison of safety and efficacy of Erector Spinae Plane Block vs Quadratus Lumborum Block for post operative analgesia in patients undergoing Percutaneous Nephrolithotomy A Randomized control trial 
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 Sniya 
Designation  Junior Resident 
Affiliation  Sri Manakula Vinayagar Medical College and Hospital 
Address  Room no 56, Division 1, Junior Resident Department of Anaesthesiology Sri Manakula Vinayagar Medical College and Hospital Pondicherry

Pondicherry
PONDICHERRY
605107
India 
Phone  8547032890  
Fax    
Email  sniyasurendran56@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suneeth P Lazarus 
Designation  HOD and Professor 
Affiliation  Sri Manakula Vinayagar Medical College and Hospital 
Address  HOD and Professor Room no: 1, Division 1, Department of Anaesthesiology Sri Manakula Vinayagar Medical College and Hospital Pondicherry

Pondicherry
PONDICHERRY
605107
India 
Phone  9894332543  
Fax    
Email  lazarus.suneeth@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suneeth P Lazarus 
Designation  HOD and Professor 
Affiliation  Sri Manakula Vinayagar Medical College and Hospital 
Address  HOD and Professor Department of Anaesthesiology Sri Manakula Vinayagar Medical College and Hospital Pondicherry

Pondicherry
PONDICHERRY
605107
India 
Phone  9894332543  
Fax    
Email  lazarus.suneeth@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Sri Manakula Vinayagar Medical College and Hospital, Pondicherry 605107, India 
 
Primary Sponsor  
Name  Dr Sniya 
Address  Junior Resident Department of Anaesthesiology Sri Manakula Vinayagar Medical College and Hospital Pondicherry 
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 Suneeth P Lazarus  Sri Manakula Vinayagar Medical College and Hospital  Room no 56, Divison 1, Sri Manakula Vinayagar Medical College and Hospital Pondicherry India 605107
Pondicherry
PONDICHERRY 
9894332543

lazarus.suneeth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMVMCH ETHICS COMMITTEE  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  Erector Spinae Plane Block   Comparing the safety and efficacy of erector Spinae Plane Block and Quadratus Lumborum Block for post operative period in PCNL surgeries using 20 ml of 0.25% BUPIVACAINE 
Comparator Agent  Quadratus Lumborum Block  Comparing the safety and efficacy of erector Spinae Plane Block and Quadratus Lumborum Block for post operative period in PCNL surgeries using 20 ml of 0.25% BUPIVACAINE 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adult age group 20 to 70 years
ASA PS I II III
Patients posted for elective PCNL 
 
ExclusionCriteria 
Details  Age group below 20 years and above 70 years
Patients with ASA PS IV
BMI above 35
Patients with cognitive disability 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Time duration of analgesia between Erector Spinae Plane Block and Quadratus Lumborum Block using visual analogue score  0 minutes, 30 minutes, 60 minutes, 1.5 hours, 3 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Time taken for first rescue analgesia  0 minutes, 30 minutes, 60 minutes, 1.5 hours, 2 hours 
Tramadol consumption in 24 hours hours  0 minutes, 30 minutes, 60 minutes, 1.5 hours, 2 hours 
Paracetamol consumption in 24 hours  0 minutes, 30 minutes, 60 minutes, 1.5 hours, 2 hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   22/05/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

Percutaneous nephrolithotomy (PCNL) is one of the commonly done surgery for treating kidney stones. But the post operative pain is intense that it requires lot of analgesics. Especially in a patient with kidney disease these drugs should be used with caution. Hence nerve blocks were tried which provides commendable analgesia and thereby reducing analgesics consumption. Erector Spinae Plane Block and Quadratus Lumborum Block are two techniques that provide excellent post operative analgesia for PCNL surgeries. Though they were individually studied and proved efficacy, they are not compared and studied adequately. So we designed this study to compare the safety and efficacy of these two techniques. Bupivacaine which is a long acting amide local anaesthetic will be used for giving blocks. We will be administering 0.25% BUPIVACAINE 20 ml in both of the techniques. The study population will be selected according to the inclusion and exclusion criteria. Those who fulfils the criteria will be eligible to participate in the study. The patient and attenders will be explained about the procedure and how to give response during the study. After obtaining consent participants will be recruited to study.

As per the plan of study,An experienced anaesthesiologist will be administering the block at the end of PCNL surgery,and he/she will be monitored for the next 24 hours for the duration of analgesia and also will be monitored for the complications. As the procedure is done under USG guidance,occurrence of complications is extremely minimal,however we will be prepared for the same. At the end of the study we hope we will be able to come to a conclusion whether ESPB or QLB provide better analgesia with fewer side effects and hence can be used for the improved patient care .

 
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