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CTRI Number  CTRI/2022/10/046588 [Registered on: 18/10/2022] Trial Registered Prospectively
Last Modified On: 18/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing mixture of local anaesthetic 0.5 % bupivacaine with fentanyl versus mixture of local anaesthetic ropivacaine 0.75% with fentanyl during operations in lower limb and lower abdomen 
Scientific Title of Study   Comparison of intrathecal 0.5% hyperbaric bupivacaine plus fentanyl with 0.75% hyperbaric ropivacaine plus fentanyl in lower limb and lower abdominal surgeries  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jeyakumaar S S G 
Designation  Postgraduate Student 
Affiliation  ESIC Medical College and PGIMSR KK Nagar 
Address  Department of Anaesthesiology Modular Operation Theatre First floor B- Block ESIC MC and PGIMSR KK Nagar Chennai
Ashok pillar road KK Nagar Chennai 600 078
Chennai
TAMIL NADU
600078
India 
Phone  9962128798  
Fax    
Email  samgjeyakumaar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Radhika K 
Designation  Professor 
Affiliation  ESIC Medical College and PGIMSR KK Nagar 
Address  Department of Anaesthesiology First floor B-Block ESIC Medical College and PGIMSR KK Nagar Chennai
Ashok pillar road KK Nagar Chennai 600 078
Chennai
TAMIL NADU
600078
India 
Phone  9840170887  
Fax    
Email  radhikamurali0095@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Radhika K 
Designation  Professor 
Affiliation  ESIC Medical College and PGIMSR KK Nagar 
Address  Department of Anaesthesiology First floor B-Block ESIC Medical College and PGIMSR KK Nagar Chennai
Ashok pillar road KK Nagar Chennai 600 078
Chennai
TAMIL NADU
600078
India 
Phone  9840170887  
Fax    
Email  radhikamurali0095@gmail.com  
 
Source of Monetary or Material Support  
ESIC Medical college and PGIMSR KK Nagar Chennai 600078 
 
Primary Sponsor  
Name  ESIC Medical College and PGIMSR KK Nagar 
Address  ESIC Medical College and PGIMSR KK Nagar Chennai 
Type of Sponsor  Government 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 Jeyakumaar S S G  ESIC Medical College and PGIMSR KK Nagar Chennai  Department of Anaesthesiology Modular Operation Theatre
Chennai
TAMIL NADU 
9962128798

samgjeyakumaar@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  Intrathecal 0.5 % Hyperbaric Bupivacaine plus Fentanyl   Dose: 3ml of Bupivacaine 5mg/ml containing dextrose 80mg/ml with fentanyl 25 mcg , Frequency: once, Route: Intrathecal, Duration of intervention: 3-4 hours  
Intervention  Intrathecal 0.75% hyperbaric Ropivacaine plus Fentanyl   Dose:3 ml of ropivacaine 7.5 mg/ml containing dextrose 80 mg/ml with fentanyl 25 mcg, Frequency:once, Route:Intrathecal, Duration of intervention :3-4 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patient with written informed consent
2 ASA physical status of I and II
3 Patient Posted for lower limb and lower abdominal surgeries
4 Age groups 18- 60 years
 
 
ExclusionCriteria 
Details  1 Patient refusal
2 Known allergy to local anaesthetics
3 Gross spinal deformities
4 Pregnancy and Lactating females
5 Contraindications to regional anaesthesia (bleeding diathesis, use of any anti-coagulants, infection at the site of injection)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of the duration of motor block between the two drugs  At 2 hours, 3 hours,4 hours,5 hours,6 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Time to onset of sensory block  Every 1 min 
Duration of sensory block  Every 15 min 
Time of motor block  Every 15 min 
Hemodynamic parameters  Every 15min 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   27/10/2022 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet using this preparation 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
            Bupivacaine, is an amino-amide compound, was synthesized and introduced into the clinical practice in 1963 and proved to be a very effective long-acting local anaesthetic agent. In 1979, Albright drew attention to the dangers of the longer acting local anaesthetic agents, bupivacaine and etidocaine, in case they gained accidental intravascular access, resulting in re-entrant arrhythmias and cardiac depression, sometimes culminating in cardiac arrest. These shortcomings, of this otherwise novel local anaesthetic, resulted in the development of a newer anaesthetic agent ropivacaine.
 Ropivacaine and levobupivacaine a new amino-amide local anaesthetic agents, are similar in chemical structure to bupivacaine. Extensive clinical data has shown that ropivacaine is effective and produces hemodynamic stability for regional anaesthetic techniques such as epidural and brachial plexus block. 
Adjutants like opioids have shown to improve the analgesic duration of post spinal anaesthesia because of their motor sparing property thereby improving the quality and success of anaesthesia. Fentanyl is the most common opioid which is extensively used as an adjuvant to hyperbaric bupivacaine for enhancement of analgesia without increasing the depth of motor and sympathetic block.    
            
         Hyperbaric ropivacaine with fentanyl has been little studied in intrathecal anaesthesia However, this hyperbaric ropivacaine were isobaric preparations. Due to that the spread of drugs could not be controlled by adjusting the positions. Currently ropivacaine has been introduced as a hyperbaric ropivacaine. Studies comparing hyperbaric ropivacaine with other drugs are very few

  Hyperbaric Ropivacaine molecule drug was launched by Neon laboratories first in india followed by other countries on 12.11.2021. No other manufactures available till now for this drug. So, the drug which was used by the previous studies was not hyperbaric ropivacaine. They have used isobaric ropivacaine and mixed with dextrose which is not a original drug molecule used by us. 

             This hyperbaric ropivacaine molecule which we have used in the original molecule by the manufacture which is approved by DGCI on 13.08.2021.

    Only one or two studies carried out in Indian Population they rest or done in western countries. The results from this study will be more valid and relevant to practising anaesthesiologists who will have access to this DGCI approved Hyperbaric Ropivacaine. This can be compared with the previous studies to see if the results are same or different.   
.
 Hence this study is conceptualized to compare the effects of block characterises such as duration of action and hemodynamic stability of hyperbaric ropivacaine plus fentanyl in spinal anaesthesia and to compare it with hyperbaric bupivacaine plus fentanyl in lower limb and lower abdominal surgeries.

 
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