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CTRI Number  CTRI/2022/09/045414 [Registered on: 12/09/2022] Trial Registered Prospectively
Last Modified On: 17/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Thish study will Compare the Efficacy of spinal anesthesia by Intrathecal Bupivacaine 0.5% versus Intrathecal 0.75% Ropivacaine in patients undergoing Lower Abdominal and Lower Limb Surgeries  
Scientific Title of Study   A Prospective Randomised Study to Compare the Efficacy of Intrathecal Bupivacaine 0.5% and Intrathecal 0.75% Ropivacaine in Lower Abdominal and Lower Limb Surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rochana Bakhshi 
Designation  Professor of Anesthesiology 
Affiliation  D Y Patil Medical College Hospital and Research Centre 
Address  D Y Patil Medical College Hospital and Research Centre D Y Patil University School of Medicine Sector 5 Nerul Navi Mumbai

Raigarh
MAHARASHTRA
400706
India 
Phone  9323272151  
Fax    
Email  drrochana@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Rochana Bakhshi 
Designation  Professor of Anesthesiology 
Affiliation  D Y Patil Medical College Hospital and Research Centre 
Address  D Y Patil Medical College Hospital and Research Centre D Y Patil University School of Medicine Sector 5 Nerul Navi Mumbai

Raigarh
MAHARASHTRA
400706
India 
Phone  9323272151  
Fax    
Email  drrochana@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Rochana Bakhshi 
Designation  Professor of Anesthesiology 
Affiliation  D Y Patil Medical College Hospital and Research Centre 
Address  D Y Patil Medical College Hospital and Research Centre D Y Patil University School of Medicine Sector 5 Nerul Navi Mumbai

Raigarh
MAHARASHTRA
400706
India 
Phone  9323272151  
Fax    
Email  drrochana@yahoo.com  
 
Source of Monetary or Material Support  
D Y Patil Medical College and Hospital 
 
Primary Sponsor  
Name  Dr Rochana Bakhshi 
Address  D Y Patil Medical College and Hospital Plot 2, Sector-5, Nerul Navi Mumbai Maharashtra INDIA 
Type of Sponsor  Other [Self] 
 
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 
Rochana Bakhshi  D Y Patil Medical College and Hospital  Department of anesthesiology Second floor D Y Patil Hospital, Nerul, Navi Mumbai 400706
Thane
MAHARASHTRA 		 9323272151

drrochana@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, D Y Patil Medical College and Hospital, Nerul, Navi Mumbai  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 0.5%  Spinal anesthesia (3.2 ml of 5.0 mg/ml) 
Intervention  Ropivacaine 0.75%  Spinal anesthesia (3.2 ml of 7.5mg/ml) 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients undergoing lower limb and lower abdominal surgeries
2. ASA I & II

 
 
ExclusionCriteria 
Details  1. ASA III & IV
2. Patients not consenting for spinal anesthesia
3. Spine abnormalities in the patient
4. Coagulation disorders
5. Patients with recent history of raised intracranial pressure
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Onset and duration of motor and sensory block   Immediate (Every two minutes for 20 minutes after administration) 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic parameters (SBP, DBP, MAP, HR)   Immediate (Every two minutes for 20 minutes after administration) 
Adverse events   From time of administration till wearing off of spinal anesthesia 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   15/09/2022 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This prospective randomised study will be conducted in Dr D.Y.Patil hospital & medical college , Navi Mumbai, Department of Anesthesiology, after institutional ethics committee clearance.

The study population will be randomly divided into two groups.

Group 1(SR) ,n=45: will receive 3.2ml of 0.75% Ropivacaine heavy

Group 2(SB), n=45: will receive 3.2ml of 0.5% Bupivacaine heavy 

The patients will be subjected to a preoperative anesthesia check.

Written informed consent will be obtained before starting any study procedures.  

Proper fasting guidelines will be explained a day prior to surgery. 

On the day of surgery After checking the patient’s written informed consent and adequate NBM status, the patient will be wheeled in operation theatre. The baseline preoperative parameters would be recorded before inducing anaesthesia. ,intravenous cannula 20gauge(G) or 18 gauge will be inserted on the upper extremity. Intravenous  fluid ,ringer lactate will be started.

Routine  Intraoperative Monitoring such as 

pulse oximeter (SpO2), 

electrocardiogram (ECG),

 non -invasive blood pressure (NIBP) will be done

Hypotension (20% decrease in MAP), if any, will be treated with intermittent boluses of intravenous ephedrine (6 mg)

Bradycardia (HR < 50/ minute) will be treated with intravenous atropine 0.6 milligram (mg) or Glycopyrrolate 0.2mg. 

Patients will receive spinal anesthesia in sitting position, under aseptic precautions with 25G, Quincke tip, spinal needle, by a qualified anesthesiologist.

Group 1 will receive intrathecal 3.2 ml of 0.75% Ropivacaine and group 2 will receive intrathecal 3.2 ml of 0.5% Bupivacaine.

Patients will be positioned supine immediately. 

Sensory block and level will be checked using a 25 G hypodermic needle.  

Heart rate (HR), systolic (SBP) , diastolic (DBP)and mean arterial pressure (MAP) will be measured every 2 mins from the onset of block for the first 20 mins, thereafter every 10 minutes till the end of the procedure. 



Onset of motor block will be defined as time from injection till motor paralysis equivalent to Bromage score 3.

Duration of sensory block will be defined as the time between onset of sensory block to return of touch sensation at L1.

Duration of motor block will be defined as the time between onset of motor block to complete return of motor power (Bromage 0).

Duration of analgesia will be defined as the time from commencement of block to time when patient first demand rescue analgesia (VAS > 4).

Pain assessment will be done by using visual analogue scale  

 

 
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