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
|
|
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
|
|
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. |