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CTRI Number  CTRI/2021/03/032460 [Registered on: 31/03/2021] Trial Registered Prospectively
Last Modified On: 31/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparative study of 0.5% bupivacaine(12mg) versus 0.5% bupivacaine(8mg) with fentanyl(25µg) for vasopressor requirement in caesarean section 
Scientific Title of Study   Comparative study of intrathecal 0.5% bupivacaine(12mg) versus 0.5% bupivacaine(8mg) with fentanyl(25µg) for ephedrine requirement in caesarean section 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Umesh G 
Designation  PG resident  
Affiliation  MS Ramaiah medical college  
Address  Department of Anaesthesiology, MS Ramaiah Medical College, New BEL road MSRIT post Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9686541639  
Fax    
Email  gumesh1994@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Leena H Parate 
Designation  Associate Professor Department of Anaesthesiology 
Affiliation  MS Ramaiah medical college 
Address  Department of Anaesthesiology MS Ramaiah medical college New bel road MSRIT post bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9480525925  
Fax    
Email  dr_leenag@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Leena H Parate 
Designation  Associate Professor Department of Anaesthesiology 
Affiliation  MS Ramaiah medical college 
Address  Department of Anaesthesiology MS Ramaiah medical college New bel road MSRIT post bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9480525925  
Fax    
Email  dr_leenag@yahoo.co.in  
 
Source of Monetary or Material Support  
MS Ramaiah Medical college DEPARTMENT OF ANAESTHESIOLOGY 2ND FLOOR NEW BEL ROAD MSRIT POST MSR NAGAR BANGALORE- 560054 
 
Primary Sponsor  
Name  MS Ramaiah medical college 
Address  New bel road MS ramaiah nagar MSRIT post bangalore - 560054 
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 Umesh G  MS Ramaiah Medical college  Department of Anaesthesiology , MS Ramaiah Medical College New bel road MS ramaiah nagar MSRIT post bangalore- 560054
Bangalore
KARNATAKA 		 9686541639

gumesh1994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MS ramaiah medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant women 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.5% heavy bupivacaine 12 mg  One of the group will receive 0.5% heavy bupivacaine 12 mg intrathecally during spinal anaesthesia in ceaserean section patients. The mean ephedrine requirement will be assessed . 
Comparator Agent  0.5% heavy bupivacaine 8 mg and fentanyl 25 mcg  The other group receives 0.5% heavy bupivacaine 8 mg and fentanyl 25 mcg intrathecally during spinal anaesthesia in ceaserean section patients . The mean ephedrine requirement will be assessed . 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Patients with ASA status I or II 
 
ExclusionCriteria 
Details  1. ASA III or IV
2. Patient refusal
3. Pregnancy related hypertension
4. Infection at the site of injection
5. Coagulopathy disorders
6. Allergy to local anesthetics
7. Musculoskeletal deformity
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the mean ephedrine requirement  Heart rate , Systolic Blood Pressure , Diastolic blood pressure and saturation will be recorded at 0 , 2, 4, 6, 8, 10, 12, 14, 20 , 25, 30, 35 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To assess - the sensory and motor level blockade
- duration of post-operative analgesia
- adverse events like nausea, vomiting and sedation
 		 Highest sensory level of blockade
Motor level of blockade according to bromage scale
Duration of post oprative analgesia
presence or absent of side effects like nausea , vomiting and sedation 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   01/04/2021 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?

  2. What additional supporting information will be shared?

  3. Who will be able to view these files?

  4. For what types of analyses will this data be available?

  5. By what mechanism will data be made available?

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - 
Brief Summary   Spinal anaesthesia is the most common method of regional block in caesarean section. It produces sympathetic block, sensory analgesia and motor block depending on the dosage, concentration or volume of local anesthetics used. The dose of local anesthetics used in spinal anaesthesia varies with height of the patient, desired segmental level, the specific gravity of the drug and use of adjuvants. The most unavoidable response of spinal anaesthesia is hypotension which directly correlates with the dose of local anaesthetics used.
The addition of opiods to local anesthetic for spinal anaesthesia was first introduced in 1979 with morphinre. Opioids are synergistic with local anesthetics and intensify the sensory block without increasing the sympathetic block. They are commonly used as adjuvants with local anesthetics for potentiating their effects , thus offering hemodynamic stability by reducing the dose and side effects of local anesthetics. In the literature very few studies have been done to assess the actual vasopressor requirement by addition of opioids. The aim of our work is to study the efficacy of intrathecal fentanyl as an adjuvant to low dose bupivacaine to conventional dose bupivacaine on vasopressor requirement in caeserean section. 
 
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