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CTRI Number  CTRI/2020/07/026615 [Registered on: 16/07/2020] Trial Registered Prospectively
Last Modified On: 11/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of analgesic effect of Ropivacaine versus Ropivacaine with Clonidine in caudal epidural block in lumbosacral spine surgery. 
Scientific Title of Study   Evaluation of analgesic effect of Ropivacaine versus Ropivacaine with Clonidine in caudal epidural block in lumbosacral spine surgery; a randomized double blind controlled interventional study at SMS hospital, Jaipur. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SHOBHA PUROHIT 
Designation  Senior professor 
Affiliation  SMS Medical college, Jaipur 
Address  Department of anaesthesia, SMS medical college and hospital, Jaipur, Rajasthan 302004 India

Jaipur
RAJASTHAN
302004
India 
Phone  7737050823  
Fax    
Email  Purohit.shobha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr SHOBHA PUROHIT 
Designation  Senior professor 
Affiliation  SMS Medical college, Jaipur 
Address  Department of anaesthesia, SMS medical college and hospital, Jaipur, Rajasthan 302004 India

Jaipur
RAJASTHAN
302004
India 
Phone  7737050823  
Fax    
Email  Purohit.shobha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Reena dave 
Designation  Junior resident 
Affiliation  SMS Medical college, Jaipur 
Address  Department of anaesthesia, SMS medical college and hospital, Jaipur Rajasthan 302004 India

Jaipur
RAJASTHAN
302004
India 
Phone  7597518124  
Fax    
Email  drreenadave1993@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology, SMS medical college and hopsital, Jaipur, Rajasthan, PIN-302004 
 
Primary Sponsor  
Name  Department of anaesthesiology SMS Medical college Jaipur Rajasthan 
Address  Department of anaesthesiology, SMS Medical college, JLN Marg, Jaipur, Rajasthan, PINCODE-302004 
Type of Sponsor  Government 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 
Dr SHOBHA PUROHIT  Sawai mansingh hospital, Jaipur  Department of anaesthesiology, 2nd floor, dhanwantri bhawan,SMS Hospital, Jaipur, Rajasthan, PIN-302004
Jaipur
RAJASTHAN 		 7737050823

Purohit.shobha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMS Medical college Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injection 0.25% ropivacaine  Injection 0.25% ropivacaine (18ml) plus normal saline (2ml)to make total volume 20 ml, caudal block 
Comparator Agent  Injection 0.25% ropivacaine and Injection clonidine 1mcg/kg  Injection 0.25% ropivacaine (18ml) plus 1mcg/kg Injection clonidine plus normal saline added to make total volume 20 ml, caudal block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients willing to give written informed consent
Patients with ASA Grade I and II
Patients undergoing lumbosacral spine surgery under general anaesthesia 
 
ExclusionCriteria 
Details  Patients having H/O allergic reactions to local anesthetics.
Patients on anticoagulant therapy and H/O coagulation disorders.
Local infection at the proposed site of puncture for caudal anaesthesia.
Patients with neurological and psychiatric disorders.
Patient with contraindication with caudal block like pilonidal sinus, congenital anomaly of spine or meninges.
Patient who had undergone previous back surgeries.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare VAS score and duration of analgesia in both groups.  Postoperatively upto 24 hours- just after extubation, 30 mins, 1,2,4,8,12 and 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To compare perioperative hemodynamic parameters (HR, SBP, DBP, MBP) in both groups.
To compare side effects, if any in both groups.
 		 Preoperative vitals
Intraoperative vitals - Baseline, just after intubation, 5 min after intubation,after prone position, just after block,5 min, 15 min and every 15 minutes thereafter
Postoperative vitals and side effects upto 24 hrs- just after extubation, 30 min, 1,2,4,8,12 and 24 hours 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   01/08/2020 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 Under communication 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 In this study we compare analgesic effect of ropivacaine alone versus ropivacaine plus clonidine in caudal epidural block in patients undergoing lumbosacral spine surgery. 
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