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CTRI Number  CTRI/2018/04/013043 [Registered on: 04/04/2018] Trial Registered Prospectively
Last Modified On: 04/04/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Levobupivacaine 0.5%(drug) at different temperatures for spinal anesthesia 
Scientific Title of Study   COMPARISON OF SUBARACHNOID BLOCK CHARACTERISTICS WITH LEVOBUPIVACAINE AT 24°C AND AT 37°C FOR INFRA UMBILICAL SURGERIES - A RANDOMIZED DOUBLE BLINDED STUDY 
Trial Acronym  RDLS 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Antony John Charles S 
Designation  Associate Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Mahatma Gandhi Medical College and Research Institute Pillaiyarkuppam road Bahour community Pondicherry

Pondicherry
PONDICHERRY
607 403
India 
Phone  8248989337  
Fax    
Email  anjocharlie@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Antony John Charles S 
Designation  Associate Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Mahatma Gandhi Medical College and Research Institute Pillaiyarkuppam road Bahour community Pondicherry

Pondicherry
PONDICHERRY
607 403
India 
Phone  8248989337  
Fax    
Email  anjocharlie@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anwar Basha S 
Designation  Junior Resident 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Mahatma Gandhi Medical College and Research Institute Pillaiyarkuppam road Bahour community Pondicherry

Pondicherry
PONDICHERRY
607 403
India 
Phone  9942335252  
Fax    
Email  anwarbashadr@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College and Research Institute Pillaiyarkuppam road Bahour community Pondicherry 
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College and Research Institute 
Address  Mahatma Gandhi Medical College and Research Institute, Pillaiyarkuppam, Pondicherry - 607 403. 
Type of Sponsor  Research institution and hospital 
 
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 
Anwar Basha S  Mahatma Gandhi Medical College and Research Institute  Mahatma Gandhi Medical College and Research Institute Anesthesiology 2nd floor(hospital)
Pondicherry
PONDICHERRY 		 9942335252

anwarbashadr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Medical College and Research Institute Pillaiyarkuppam, Pondicherry - 607 403  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  1. Age 18yrs to 75 yrs. 2. ASA I/II/III posted for infra umbilical surgeries. ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Levobupivacaine 0.5% at body temperature  The Group B patients will receive 3ml (15mg) of 0.5% of warm levobupivacaine (37 degree Celsius). The levobupivacaine will be warmed to 37 degrees(body temperature) using a digital dry bath. 
Comparator Agent  Levobupivacaine 0.5% at room temperature  The Group A patients will recieve 3ml (15mg) of 0.5% of isobaric levobupivacaine at room temperature (24 degree Celsius). 
Intervention  Subarachnoid block  Levobupivacaine 0.5% is injected intrathecally without barbotage 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  ASA I/II/III posted for infra umbilical surgeries 
 
ExclusionCriteria 
Details  1.Patient refusal
2. Contraindication to spinal anesthesia
3. Pregnant patients
4. Height<150 cm.
5. Patients with any pre-existing neurological deficits.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Time taken to achieve Sensory level of T10.  within 30min of injectate 
 
Secondary Outcome  
Outcome  TimePoints 
Onset of sensory block.
Onset of motor block.
Time to achieve maximum level of sensory blockade.
Time to readiness for surgery.
Duration of sensory blockade.
Time of two level regression of maximum sensory block attained.
Side effects. 		 within 30min of injectate
within 30min of injectate
within 30min of injectate
when sensory numbness in dermatome T10 level is achieved.
-
1-2hrs from time of injectate
if any
 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   15/04/2018 
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   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a randomized double-blinded study comparing the characteristics of subarachnoid block with levobupivacaine at 24ºC and 37ºC for infra-umbilical surgeries. The purpose of the study is to identify whether the temperature of levobupivacaine at body temperature 37ºC and room temperature 24 ÂºC has an effect on the action of the drug in the subarachnoid block.

 
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