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CTRI Number  CTRI/2023/05/052606 [Registered on: 12/05/2023] Trial Registered Prospectively
Last Modified On: 10/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study of heavy ropivacaine 0.75% with heavy bupivacaine 0.5% in spinal anaesthesia for below umbilical surgeries. 
Scientific Title of Study   A prospective randomized comparative study of hyperbaric ropivacaine 0.75% versus hyperbaric bupivacaine 0.5% in spinal anaesthesia for elective infraumbilical surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anula Sharan Dsouza 
Designation  Junior resident 
Affiliation  Kasturba Medical College 
Address  Department of Anaesthesiology Kasturba Medical College KMC Manipal
Kasturba Medical College KMC Manipal
Udupi
KARNATAKA
576104
India 
Phone  9686425707  
Fax    
Email  anusap04@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Deepali Shetty 
Designation  Senior resident  
Affiliation  Kasturba medical college 
Address  Department of Anaesthesiology Kasturba medical college, Manipal
Kasturba medical college, Manipal
Udupi
KARNATAKA
576104
India 
Phone  7349215023  
Fax    
Email  deepali.shetty@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Deepali Shetty 
Designation  Senior resident  
Affiliation  Kasturba medical college  
Address  Department of Anaesthesiology Kasturba medical college KMC Manipal
Kasturba medical college KMC Manipal
Udupi
KARNATAKA
576104
India 
Phone  7349215023  
Fax    
Email  deepali.shetty@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College Manipal Manipal Udupi 576104 
 
Primary Sponsor  
Name  Kasturba medical college  
Address  Manipal academy of higher education Manipal , Udupi , Karnataka 5756104 
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 Anula Sharan Dsouza  Kasturba medical college  Department of anaesthesiology Kasturba medical college Manipal academy of higher education Manipal , Udupi , Karnataka 576104
Udupi
KARNATAKA 
9686425707

anusap04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba medical college and Kasturba Medical College 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  0.5% Hyperbaric Bupivacaine  Group B - 2.6ml of 0.5% Hyperbaric Bupivacaine Administered Intrathecally at the start of procedure Duration of action : 3 hours 
Intervention  0.75% Hyperbaric Ropivacaine   Group R : 2.6ml of 0.75% hyperbaric ropivacaine Administered Intrathecally at the start of procedure Duration of action : 3 hours  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients undergoing elective infraumbilical or
lower limb surgery under spinal anaesthesia.
2. Who belong to American Society of
Anesthesiologists Physical Status I or II will be
included in the study. 
 
ExclusionCriteria 
Details  • Patient refusal
• Infection at the site of injection
• Uncorrected hypovolemia
• Allergy
• Increased intracranial pressure
• Coagulopathy
• Sepsis
• Fixed cardiac output states
• Indeterminate neurological disease
• Patients in altered mental status
• Pregnant females.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Time taken for onset of sensory and motor blockade.
2.Time to achieve maximum sensory level.
3.Time for 2-segment regression.
4.Time taken for sensory and motor recovery.
 
1.Sensory blockade immediately after administering spinal anaesthesia ( baseline ) followed by every 2 min from baseline until T10 block achieved
2.Motor blockade at
Baseline followed by every 2 min from baseline till bromage scale - 3 or complete motor blockade achieved.
3.Sensory level will be checked at baseline followed by every 5 minutes from
baseline thereafter till the end of 1 hour, and every 15 minutes thereafter till 2-segment regression  
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in vital parameters (heart rate, blood pressure , respiratory rate, oxygen saturation)
Frequency of adverse events
 
1.Blood pressure will be recorded at baseline ( immediately after administering spinal anaesthesia ) followed by every 5 minutes from baseline for the first hour and every 15 minutes thereafter till complete sensory and motor recovery.
2. Heart rate will be recorded at baseline followed by every 5 minutes from baseline for the first hour and every 15 minutes thereafter till recovery from sensory and motor blockade. 
 
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   Phase 4 
Date of First Enrollment (India)   22/05/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not published in any international or national journal. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The duration of the sensory block with ropivacaine is found to be similar with bupivacaine and the motor block was significantly shorter. Due to less lipophilic property and stereo selective structure ropivacaine has significantly higher threshold for cardio toxicity and CNS toxicity than bupivacaine. As hyperbaric ropivacaine is now commercially available we plan to study its efficacy and safety compared to the routine hyperbaric bupivacaine in patients undergoing spinal anesthesia for elective infraumbilical surgeries. Anesthesiology resident (blinded to the study) will examine the patients preoperatively to ensure that the inclusion criteria is met. Informed consents will be taken of the eligible participants, and they will be kept nil per oral for solids 6 hours and for liquids 2 hours prior to the surgery. Patients will be allocated into two groups - Group B receiving - 5% hyperbaric  bupivacaine and Group R - receiving 0.75% hyperbaric ropivacaine. Onset of analgesia at T10 will be noted. The sensory level will be checked every 2 minutes as described above until the level does not ascend any further for 4 consecutive readings. Sensory level will be checked every 5 minutes thereafter till the end of 1 hour, and every 15 minutes thereafter till 2-segment regression and sensory recovery (around S2-S4 segments) occur. Motor blockade will be assessed by modified Bromage scale (0-1-2-3) at similar intervals as assessment of sensory block. Motor blockade will be evaluated at 2-minute intervals till a modified Bromage score of 3 is obtained or till maximum motor blockade is achieved. This time is noted as onset of motor blockade. The time at which ankle movement returns is noted to indicate recovery from motor blockadeBlood pressure will be recorded every 5 minutes for the first hour and every 15 minutes thereafter till complete sensory and motor recovery More than a 25% decrease in mean arterial pressure will be treated with intravenous fluids and vasopressor (mephentermine 3 mg/bolus). Heart rate will be recorded every 5 minutes for the first hour and every 15 minutes thereafter till recovery from sensory and motor blockade. A heart rate < 50/min will be considered as bradycardia but will be treated only if associated with hypotension. A respiratory rate less than 8/min or pulse oximetry values less than 95% on room air will be taken as significant and nasal oxygen 3 to 5 litres/min will used as rescue. Any adverse effects such as nausea, vomiting, pruritus will be noted. The inference concluded from the study shall enhance our knowledge about 0.75% hyperbaric ropivacaine and may lead to preferential selection of the drug.

 
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