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CTRI Number  CTRI/2013/02/003382 [Registered on: 12/02/2013] Trial Registered Retrospectively
Last Modified On: 28/09/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Using two different doses of bupivacaine for spinal block. 
Scientific Title of Study   Effect of Intrathecal dose of plain bupivacaine on epidural volume extension induced sensory block augmentation- A randomized controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
13370  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Asha Tyagi 
Designation  Reader 
Affiliation  University College of Medical Sciences and GTB Hospital 
Address  Department of Anaesthesiology and Critical Care University College of Medical Sciences and GTB Hospital Shahadra Delhi

East
DELHI
110095
India 
Phone    
Fax    
Email  drashatyagi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Asha Tyagi 
Designation  Reader 
Affiliation   
Address  Department of Anaesthesiology and Critical Care University College of Medical Sciences and GTB Hospital Shahadra Delhi

East
DELHI
110095
India 
Phone    
Fax    
Email  drashatyagi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Asha Tyagi 
Designation  Reader 
Affiliation   
Address  Department of Anaesthesiology and Critical Care University College of Medical Sciences and GTB Hospital Shahadra Delhi

East
DELHI
110095
India 
Phone    
Fax    
Email  drashatyagi@gmail.com  
 
Source of Monetary or Material Support  
Dept of Anaesthesiology and Critical Care University College of Medical Sciences and GTB Hospital 
 
Primary Sponsor  
Name  University College of Medical Sciences and GTB Hospital 
Address  University College of Medical Sciences and GTB Hospital 
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 
Asha Tyagi  Dept of Anaesthesiology and Critical Care University College of Medical Sciences and GTB Hospital  Dilshad Garden Shahdra 110095
East
DELHI 		 9818606404

drashatyagi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of GTB Hospital; Shahdra; Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  anaesthesia for orthopedic surgery of lower limb fractures:,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Plain Bupivacaine (0.5%)   Plain Bupivacaine (0.5%) in a dose of 5 mg injected intrathecally during spinal block; followed by standardized epidural volume extension. 
Comparator Agent  Plain Bupivacaine (0.5%)in a different dose  Plain Bupivacaine (0.5%) in a dose of 10 mg injected intrathecally during spinal block; followed by standardized epidural volume extension. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  consenting adult male patients of ASA physical status I or II with body weight between 50-70 kg and height of 150-180 cm undergoing orthopedic surgery for fracture in lower limb using combined spinal epidural anaesthesia. 
 
ExclusionCriteria 
Details  Patients with diabetes mellitus, history of spinal disease or coagulation abnormalities, skin infection at site of injection and other contraindications to combined spinal epidural anaesthesia including sensitivity to local anesthetics  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
dermatomal increase in maximum sensory block produced by epidural volume extension  Every 2 minutes, the sensory level will be assessed till 3 consecutive identical readings are obtained (before and after the epidural volume extension). 
 
Secondary Outcome  
Outcome  TimePoints 
motor blockade  same as sensory level monitoring to attain grade of maximum motor block. 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   01/10/2011 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Epidural volume extension is a commonly practiced anaesthetic technique, used following a deliberately reduced or inadequate dose of the intrathecal drug. Whether reduction in the intrathecal doses with a consequently decreased spread in cerebrospinal fluid can limit the epidural volume extension induced cephalic spread, and hence the sensory block augmentation, has not been evaluated till date.

The present research plans to investigate whether the dose of intrathecal plain bupivacaine determines the epidural volume extension induced sensory block augmentation. The aim is to assess the application of epidural volume extension to two clinically used doses of intrathecal plain bupivacaine. The null hypothesis is that there is no difference in epidural volume extension induced dermatomal increase in sensory block following its application to intrathecal injection of 5 mg and 10 mg plain bupivacaine.  

 
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