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CTRI Number  CTRI/2020/07/026304 [Registered on: 02/07/2020] Trial Registered Prospectively
Last Modified On: 27/06/2020
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   Comparison of the maximum level of block achieved in Spinal anaesthesia between Bupivacaine (Local anesthetic drug) and Bupivacaine (Local anaesthetic drug) along with Fentanyl (Opioid analgesics). 
Scientific Title of Study   Comparison of the maximum sensory level achieved in Subarachnoid block between hyperbaric Bupivacaine and hyperbaric Bupivacaine along with Fentanyl: A Randomized Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arun Kumar Sah 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology and Critical care JIPMER Dhanvantari Nagar 605006 Puducherry India

Pondicherry
PONDICHERRY
605006
India 
Phone  7782007253  
Fax    
Email  drarunksah1012@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr MVS Satya Prakash 
Designation  Additional Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology and Critical care JIPMER Dhanvantari Nagar 605006 Puducherry India

Pondicherry
PONDICHERRY
605006
India 
Phone  9786184626  
Fax    
Email  munaganuri1975@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr MVS Satya Prakash 
Designation  Additional Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology and Critical care JIPMER Dhanvantari Nagar 605006 Puducherry India

Pondicherry
PONDICHERRY
605006
India 
Phone  9786184626  
Fax    
Email  munaganuri1975@yahoo.co.in  
 
Source of Monetary or Material Support  
Not Applicable 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Medical Education and Research 
Address  Dhanvantari Nagar, JIPMER, Puducherry, 605006 
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 
Dr Arun Kumar Sah  Jawaharlal Institute of Postgraduate Medical Education and Research  Department of Anaesthesiology and Critical Care, 2nd Floor, Old Block, Dhanvantari Nagar, Puducherry 605006
Pondicherry
PONDICHERRY 		 7782007253

drarunksah1012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Interventional Studies  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 
Comparator Agent  Bupivacaine and Bupivacaine along with Fentanyl  Comparison of the maximum sensory level achieved in Subarachnoid block between hyperbaric Bupivacaine [3 ml (15 mg), intrathecal, single shot] and hyperbaric Bupivacaine [2.5 ml (12.5 mg), intrathecal, single shot] along with Fentanyl [0.5 ml (25 microgram), intrathecal, single shot]. 
Intervention  Subarachnoid block  Comparison of the maximum sensory level achieved in Subarachnoid block between hyperbaric Bupivacaine and hyperbaric Bupivacaine along with Fentanyl. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing elective surgeries under subarachnoid block with American Society of Anaesthesiologists (ASA) Physical status I and II 
 
ExclusionCriteria 
Details  i.Allergy to drugs being used
ii.Patient with neuromuscular diseases
iii.Pregnant women
iv.Symptomatic bradycardia
v.Any contraindication for Subarachnoid block
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the maximum sensory level achieved in Subarachnoid block with bupivacaine and bupivacaine along with fentanyl.  After 20 minutes of the procedure i.e subarachnoid block 
 
Secondary Outcome  
Outcome  TimePoints 
To identify the association of the maximum sensory level achieved in Subarachnoid block with various physical parameters of patients (weight, height, body mass index, abdominal girth and vertebral column length) undergoing lower abdominal and lower limb surgeries.  just before performing the procedure 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   30/08/2020 
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="1"
Months="0"
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)?  

Brief Summary  

Subarachnoid block is the commonly practiced anaesthesia for surgeries of lower abdominal and lower limb. It enables the patient to be fully awake and avoids the side effects of anaesthetic drugs and gases. Intrathecal bupivacaine is most commonly preferred local anaesthetics these days to attain the surgical plane of anaesthesia/adequate sensory and motor blockade. Fentanyl is lipophilic opioid administered intrathecally as adjuvants to bupivacaine. It helps in increasing the duration of anaesthesia, depth of sensory blockade and reducing the dosage of local anaesthetics.

 
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