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CTRI Number  CTRI/2021/03/031742 [Registered on: 05/03/2021] Trial Registered Prospectively
Last Modified On: 04/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of Paravertebral block and Quadratus lumborum block for post operative analgesia in Percutaneous nephrolithotomy surgeries  
Scientific Title of Study   Efficacy of Paravertebral block and Quadratus lumborum block for post operative analgesia in PCNL surgeries, a Randoized, comparative study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sahithi Puli 
Designation  POSTGRADUATE MD ANAESTHESIA 
Affiliation  Narayana hospitals 
Address  Department of Anaesthesia,Narayana Medical college and hospital,Chintareddy palem, Nellore, 524004
Department of Anaesthesia,Narayana Medical college and hospital,Chintareddy palem, Nellore, 524004
Nellore
ANDHRA PRADESH
524004
India 
Phone  9440244662  
Fax    
Email  sahithinaidup@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Krishna Chaithanya K 
Designation  PROFESSOR 
Affiliation  narayana hospitals 
Address  Department of Anesthesiology,2nd floor,Narayana Medical college and hospital,Chintareddy palem, Nellore, 524004
Department of Anesthesiology,2nd floor,Narayana Medical college and hospital,Chintareddy palem, Nellore, 524004
Nellore
ANDHRA PRADESH
524004
India 
Phone  9849086480  
Fax    
Email  chaithu8@gmail.com  
 
Details of Contact Person
Public Query  
Name  Krishna Chaithanya K 
Designation  PROFESSOR 
Affiliation  narayana hospitals 
Address  Department of Anesthesiology, 2 nd floor,Narayana Medical college and hospital,Chintareddy palem, Nellore, 524004
Department of Anesthesiology, 2 nd floor,Narayana Medical college and hospital,Chintareddy palem, Nellore, 524004
Nellore
ANDHRA PRADESH
524004
India 
Phone  9849086480  
Fax    
Email  chaithu8@gmail.com  
 
Source of Monetary or Material Support  
Narayana Medical college,Chintareddy palem, Nellore, 524004 
 
Primary Sponsor  
Name  NARAYANA MEDICAL COLLEGE AND HOSPITAL 
Address  Narayana Medical college,Chintareddy palem, Nellore, 524004 
Type of Sponsor  Private medical college 
 
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 
Drsahithi p  Narayana medical college and hospital  Department of Anesthesiology and Department of Urology
Nellore
ANDHRA PRADESH 		 9440244662

sahithinaidup@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Medical COllege  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N22||Calculus of urinary tract in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group P( Intervention group)  Patients receiving paravertebral block for post operative analgesia in pcnl surgeries 
Comparator Agent  Group Q(comarator agent)  Patients receiving Quadratus Lumborum block for post operative analgesia in pcnl surgeries 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade I & II
Posted for PCNL Surgeries
valid and informed consent 
 
ExclusionCriteria 
Details  Patient refusal
Patients with hemorrhagic disorder and on anticoagulant therapy
Disease and deformities of spine 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
DURATION OF ANALGESIA  UPTO 24 HOURS POSTOPERATIVE PERIOD 
 
Secondary Outcome  
Outcome  TimePoints 
TIME FOR FIRST RESCUE ANALGESIA
TOTAL REQUIREMENT OF OPIOIDS. 		 UPTO 24 HOURS POSTOPERATIVE PERIOD 
 
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   N/A 
Date of First Enrollment (India)   05/03/2021 
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="0"
Months="6"
Days="0" 
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)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sahithinaidup@hotmail.com].

  6. For how long will this data be available start date provided 01-07-2021 and end date provided 20-02-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - sahithinaidup@hotmail.com
Brief Summary   There are many studies regarding efficacy of Paravertebral block for post operative analgesia in pcnl surgeries and efficacy of Quadratus lumborum block for post operative analgesia in pcnl surgeries but there are no comparative studies between them as such. Hence our aim is to compare the efficacy of paravertebral block for post operative analgesia and efficacy of Quadratus lumborum block for postoperative analgesia in pcnl surgeries. 
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