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CTRI Number  CTRI/2022/03/041442 [Registered on: 29/03/2022] Trial Registered Prospectively
Last Modified On: 06/01/2023
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   Bupivacaine for Subarachnoid block either premixed with Fentanyl or administered before of after it.  
Scientific Title of Study   Subarachnoid block characteristics following coadministration of Fentanyl premixed with hyperbaric Bupivacaine versus antecedent or succedent to hyperbaric Bupivacaine. A randomised controlled study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lipika Saxena 
Designation  Post graduate resident 
Affiliation  Mahatma Gandhi University Of Medical Sciences and technology 
Address  Department of Anesthesia, Main OT Complex, Mahatma Gandhi Medical College, RIICO Industrial area, Sitapura, jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9717728035  
Fax    
Email  dr.lipikasaxena@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Avnish Bharadwaj 
Designation  Professor 
Affiliation  Mahatma Gandhi University Of Medical Sciences and technology 
Address  Department of Anesthesia, Main OT Complex, Mahatma Gandhi Medical College, RIICO Industrial area, Sitapura

Jaipur
RAJASTHAN
302022
India 
Phone  9314882845  
Fax    
Email  avnishbharadwaj1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Avnish Bharadwaj 
Designation  Professor 
Affiliation  Mahatma Gandhi University Of Medical Sciences and technology 
Address  Department of Anestheia, Main OT Complex, Mahatma Gandhi Medical College, RIICO Industrial area, Sitapura

Jaipur
RAJASTHAN
302022
India 
Phone  9314882845  
Fax    
Email  avnishbharadwaj1@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College and Hospital 
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College 
Address  RIICO INDUSTRIAL AREA, SITAPURA , JAIPUR, RAJASTHAN 
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 Avnish Bharadwaj  mahatma gandhi medical college and hospital  Main OT Complex, Department of Anesthesia 2nd Floor
Jaipur
RAJASTHAN 
9314882845

avnishbharadwaj1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional 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 
Comparator Agent  Bupivacaine  Patients will receive 3.0 ml (125mg) of 0.5% hyperbaric bupivacaine in a 5.0 ml syringe once as bolus in subarachnoid block. 
Comparator Agent  Bupivacaine followed by Fentanyl  Patients will receive 3.0 ml (12.5 mg) of 0.5% hyperbaric bupivacaine in a 5.0 ml syringe followed by 0.5 ml (25 microgram) of fentanyl in a 1.0 ml syringe once in subarachnoid block 
Comparator Agent  Fentanyl followed by Bupivacaine  Patients will first receive 0.5 ml (25 microgram) of fentanyl in a 1.0 ml syringe followed by 3.0 ml (12.5 mg) of 0.5% hyperbaric bupivacaine in a 5.0 ml syringe once in subarachnoid block  
Comparator Agent  Premixed Bupivacaine and Fentanyl  Patients will receive 3.0ml (12.5 mg) of 0.5% hyperbaric bupivacaine and 0.5 ml (25 microgram) of fentanyl premixed in a single 5.0 ml syringe once as bolus in subarachnoid block. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients scheduled for elective lower limb surgeries under subarachnoid block.
2.Patients weighing 50 to 70 kgs.
3.Patient under ASA CLASS I/ II /III.
4.Patient’s with written and informed consent.
 
 
ExclusionCriteria 
Details  1.Patient belonging to ASA CLASS IV & V.
2.Patients allergic to the study drugs.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the Onset and Duration of Sensory and Motor block in minutes.
To study the variation in Systolic and Diastolic BP, Mean Arterial Pressure, Heart Rate, Respiratory Rate, SPO2. 
Intraoperative 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the need of rescue postoperative analgesia in next 24 hr.
2.To study the postoperative side effects viz Nausea, vomiting, Itching, Urinary retention, respiratory depression etc.

 
Postoperative 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
Final Enrollment numbers achieved (Total)= "160"
Final Enrollment numbers achieved (India)="160" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/03/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 06/09/2022 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Subarachnoid block is the most commonly used anesthesia technique for lower limb surgeries and hyperbaric Bupivacaine is the most commonly used local anesthetics for it. Several adjuvants or additives including various opioids, alpha agonists, neostigmine, ketamine, dexamethasone have been used mixing with the bupivacaine to enhance the quality of subarachnoid block.

Though the Fentanyl has been used extensively premixed with hyperbaric bupivacaine for spinal anesthesia, there is paucity of literature on clinical effects and understanding of mechanism of influence of fentanyl on subarachnoid block produced by hyperbaric bupivacaine when administered separately by another syringe, either before or after bupivacaine.

We propose that cerebrospinal fluid dynamics and pharmacokinetics may be affected differently when fentanyl is co-administered in subarachnoid space premixed with bupivacaine compared to when administered separately before or after hyperbaric Bupivacaine. That is the rationale of proposal for conducting this clinical study where in we wish to evaluate the difference in onset and duration of sensory and motor block and the incidence of hypotension after administering hyperbaric Bupivacaine and Fentanyl either in a single syringe or in different syringes prior to hyperbaric Bupivacaine and vice versa.


 
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