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CTRI Number  CTRI/2023/09/057943 [Registered on: 22/09/2023] Trial Registered Prospectively
Last Modified On: 07/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to know the effect of injection of normal saline through epidural catheter on the level of spinal anaesthesia in patients undergoing lower limb surgeries. 
Scientific Title of Study   A prospective randomised study to evaluate the influence of epidural volume extension on spinal block with hyperbaric levobupivacaine for lower limb surgeries 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kavana S 
Designation  PG resident  
Affiliation  M S Ramaiah Medical College  
Address  Department of Anaesthesiology M S Ramaiah medical college MSRIT Post Bangalore 560054 KARNATAKA

Bangalore
KARNATAKA
560054
India 
Phone  8762913202  
Fax    
Email  kavana17297@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Archana S 
Designation  Associate Professor 
Affiliation  M S Ramaiah medical college 
Address  Department of Anaesthesiology M S Ramaiah medical college MSRIT Post Bangalore KARNATAKA 560054

Bangalore
KARNATAKA
560054
India 
Phone  9845121444  
Fax    
Email  archvinddoc@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Archana S 
Designation  Associate Professor 
Affiliation  M S Ramaiah medical college 
Address  Department of Anaesthesiology M S Ramaiah medical college MSRIT Post Bangalore KARNATAKA 560054

Bangalore
KARNATAKA
560054
India 
Phone  9845121444  
Fax    
Email  archvinddoc@yahoo.co.in  
 
Source of Monetary or Material Support  
M S Ramaiah medical college MSRIT post, Bangalore 560054 Karnataka 
 
Primary Sponsor  
Name  M S Rmaiah medical college 
Address  New BEL Road MSRIT Post MSR Nagar Bangalore 560054 
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 
Dr Kavana S  M S Ramaiah Medical College Hospital  Department of Anaesthesiology Second Floor M S Ramaiah nedical college hospital New BEL road banglore
Bangalore
KARNATAKA 		 8762913202

kavana17297@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MS Ramaiah College 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  Group A   patients in group a will recieve intrathecal 2.5ml of 0.5% hyperbaric levobupivacaine with epidural volume extension with 10ml normal saline 
Comparator Agent  Group B   group B will recieve inthrathecal 2.5ml 0.5% hyperbaric levobupivacaine without epidural volume extension 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  all patients undergoing elective lower limb surgeries under combined spinal epidural anaesthesia who fit into american society of anaesthesiologists (ASA) physical status I and II  
 
ExclusionCriteria 
Details  american society of anaesthesiologist (ASA) physical status III and above
patient refusal
patients in whom CSEA is contraindicated
patients having allergy to drugs used in the study 
 
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 
onset & duration of sensory blockade
maximum level of sensory blockade achieved
onset and duration of motor blockade 		 levels will be tested every minute until highest level is achieved & every 10 mins there after until 2 segment regression is achieved 
 
Secondary Outcome  
Outcome  TimePoints 
hypotension
bradycardia
side effects like nausea , vomiting , shivering 		 the hemodynamic parameters will be checked every 2mins interval for 1st 10mins, followed by ever 5mins for next 20 mins & every 10mins till the end of surgery 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/10/2023 
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)   Not Applicable 
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 - 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
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kavana17297@gmail.com].

  6. For how long will this data be available start date provided 01-08-2025 and end date provided 01-08-2030?
    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 - nil
Brief Summary   combined spinal epidural anesthesia is a  regional anesthesia technique preferred for lower limb surgeries due to its rapid onset through the spinal component and post operative pain relive through epidural component while avoiding the disadvantages of both. epidural volume extension is a modification of combined spinal epidural anesthesia where in normal saline is injected into the epidural space immedietly after the intrathecal dose as a part of CSEA so the injected volume of fluid in the epidural space causes compression of the CSF resulting in cephalad spread of local anesthetic present in the subarachnoid space. So in the present study  objective is to compare the onset and duration of sensory blockade , maximum level of sensory blockade achieved and onset and duration of motor blockade. And also to compare thr effect of hemodynamic changes like hypotension, bradycardia and other side effects like nausea, vomiting and shivering. 
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