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CTRI Number  CTRI/2018/04/013184 [Registered on: 11/04/2018] Trial Registered Prospectively
Last Modified On: 11/04/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   injection of anesthetic medicine in fraction versus in single bolus for lower limb and lower abdominal surgeries 
Scientific Title of Study   Comparison of efficacy of fractionated versus single bolus dose of spinal anaesthesia with 0.5% heavy bupivacaine for lower abdominal and lower limb surgeries: A prospective randomised controlled trial 
Trial Acronym  FSA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shilp Bhimasen Joshi 
Designation  Assistant Professor 
Affiliation  St. Johns Medical College  
Address  St Johns Medical College Kormangala Bangalore
St Johns Medical College Kormangala Bangalore
Bangalore
KARNATAKA
560034
India 
Phone  09901405136  
Fax    
Email  drshilpa.josh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shilp Bhimasen Joshi 
Designation  Assistant Professor 
Affiliation  St. Johns Medical College Hospital 
Address  St Johns Medical College Hospital Kormangala Bangalore
2nd floor , OT complex, St Johns Medical College Hospital Kormangala Bangalore
Bangalore
KARNATAKA
560034
India 
Phone  09901405136  
Fax    
Email  drshilpa.josh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Manjuladevi 
Designation  Associate Professor 
Affiliation  St. Johns Medical College  
Address  St Johns Medical College Hospital Kormangala Bangalore
2nd floor, OT complex, St Johns Medical College Hospital Kormangala Bangalore
Bangalore
KARNATAKA
5600346
India 
Phone  09449059395  
Fax    
Email  drmanjula95@yahoo.com  
 
Source of Monetary or Material Support  
St Johns Medical College Hospital Kormangala Bengaluru 560034 Karnataka, India 
 
Primary Sponsor  
Name  Shilpa Bhimasen Joshi 
Address  St Johns Medical College Hospital Kormangala Bangalore 
Type of Sponsor  Other [] 
 
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 
Shilpa Bhimasen Joshi  St Johns Medical College  2nd floor, OT complex St Johns Medical College Kormangala Bangalore
Bangalore
KARNATAKA 
9901405136

drshilpa.josh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics Commiittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients posted for lower abdominal and lower limb surgeries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group B  3.6 ml of 0.5% hyperbaric Bupivacaine, Group F : 3.6 ml of 0.5% hyperbaric Bupivacaine in fractionated approach.  
Intervention  Group F  2.4cc(2/3rd) will be given first and then the remaining 1.2ml (1/3rd) will be given after 120sec. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I-II patients undergoing lower abdominal or lower limb surgery under spinal anesthesia 
 
ExclusionCriteria 
Details  a)Patient refusal
b)Allergy to Bupivacaine
c)Body mass index (BMI) > 35
d)Intra-operative conversion to general anesthesia (GA) / inadequate or failed spinal block
e)Pregnant and lactating mothers
f)Known bleeding diathesis or with any coagulation abnormalities
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the onset, peak and duration of sensory and motor block in fractionated and single bolus dose of spinal anesthesia with 0.5% heavy bupivacaine for lower abdominal and lower limb surgeries.   5,10,15,20,25,30,60,90,120,150,180,210 minutes after spinal injection 
 
Secondary Outcome  
Outcome  TimePoints 
1)To compare the intraoperative hemodynamics heart rate, saturation,systolic blood pressure, diastolic blood pressure, mean blood pressure and any side effects

 
5,10,15,20,25,30,60,90,120,150,180,210 minutes after spinal injection 
 
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)   16/04/2018 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1)Badheka JP, Oza VP, Vyas A, Baria D, Nehra P, Babu T. Comparison of fractionated dose versus bolus dose injection in spinal anaesthesia for patients undergoing elective caesarean section: A randomised, double-blind study. Indian J Anaesth 2017;61:55-60 2)K. S. Sunitha, Mohammed Naveed. ”Can Fractionated Spinal Anesthesia Be An Economical Alternative Technique To Combined Spinal-Epidural Anesthesia??”. Journal of Evidence based Medicine and Healthcare; Volume 2, Issue 5, February 02, 2015; Page: 477-86.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

After ethical committee approval and informed consent, patients will be recruited for the study. Preoperative evaluation is doneand  the subjects will be randomized via computer generated table and  allocated to one of the groups.  Group B:  3.6 ml of  0.5%  hyperbaric Bupivacaine, Group F : 3.6 ml of  0.5%  hyperbaric Bupivacaine in fractionated approach.   Demographic details (Age, sex, weight, ASA status, height) will be noted.

 

As a standard practice, pre-operatively patients will be kept fasting for 6 hours. They will be routinely premedicated with Tab. Alprazolam 0.5 mg and Tab. Pantoprazole 40 mg on the night prior to surgery and on the morning of surgery. 

 

Intraoperatively patients will be monitored by electrocardiography, non-invasive blood pressure and pulse oximetry.  In group B - Spinal anesthesia will be given with 3.6cc of 0.5% heavy Bupivacaine at L3-4 interspace via 25 G spinal needle, with subject  in the sitting position . In group F - Spinal anesthesia  of 3.6cc of 0.5% heavy Bupivacaine at L3-4 interspace via 25 G spinal needle will be given in a fractionated approach where 2.4cc(2/3rd) will be given first and then the remaining 1.2ml (1/3rd) will be given after 120sec.The subject will made to lie supinesoon  after the injection. At 5 mins after the injection, level of block –sensory by pinprick and motor by bromage scale will be checked. This  will be considered as onset of sensory and motor block.  At 20min, the peak level of sensory and motor block willalso  be noted.

 

The duration of spinal anesthesia is considered as two segment regression from  the level of sensory block achieved  at 20min(peak) of sensory block . At the end of surgery, both the sensory level and motor block will be rechecked. Vitals such as   Heart rate (HR),   Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean arterial blood pressure (MAP), saturation (SpO2) will be measured at every  5 mins for 1sthour and then 10min till the end of surgery.

 

Any side effects of the spinal anesthesia  such as: Bradycardia (HR < 20% of baseline), Hypotension (BP < 25% of baseline), Respiratory depression, Sedation, Pruritis and Nausea/ Vomiting will be noted and treated appropriately. Bradycardia will be treated with Injection Atropine 20mcg/kg IV and Hypotension by IV fluids/ injection Mephentermine 3 mg  IV boluses.

 

The data will be collected in the study proforma and analyzed for statistical significance with the statistician.

 
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