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CTRI Number  CTRI/2022/04/042328 [Registered on: 29/04/2022] Trial Registered Prospectively
Last Modified On: 21/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare spinal anesthesia in caesarean section when drug is given according to height and weight versus a fixed dose. 
Scientific Title of Study   Comparison of spinal block characteristics between height and weight based dosage versus fixed dosage of intrathecal bupivacaine for elective 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  Rohit Kamal 
Designation  Post Graduate student 
Affiliation  Saveetha Medical College and Hospital 
Address  Department of Anaesthesia, Hospital building Second floor, near OT complex, Saveetha Medical College, Thandalam, Chennai 602105

Kancheepuram
TAMIL NADU
602105
India 
Phone  9003133672  
Fax    
Email  rohankamal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gunasekaran Kalliyaperumal 
Designation  Professor 
Affiliation  Saveetha Medical College and Hospital 
Address  Anaesthesia department, second floor hospital building, OT complex, Saveetha Medical College, Thandalam, Chennai 602105

Kancheepuram
TAMIL NADU
602105
India 
Phone  9566137571  
Fax    
Email  guna.kali@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Rohit Kamal 
Designation  Post Graduate student 
Affiliation  Saveetha Medical College and Hospital 
Address  Anaesthesia department, second floor hospital building, OT complex, Saveetha Medical College, Thandalam, Chennai 602105

Kancheepuram
TAMIL NADU
602105
India 
Phone  9003133672  
Fax    
Email  rohankamal@gmail.com  
 
Source of Monetary or Material Support  
Saveetha medical college hospital, Thandalam ,Chennai 602105 
 
Primary Sponsor  
Name  Saveetha medical college hospital 
Address  Saveetha medical college hospital, Thandalam, Chennai, Tamil Nadu 602105 
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 
rohit kamal  Saveetha Medical College and Hospital   obstetrics operation theatre , 1st floor, Saveetha medical college hospital, Thandalam, Chennai
Chennai
TAMIL NADU 
9003133672

rohankamal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fixed dose bupivacaine   Single shot Subarachnoid block with fixed dose of 2ml of 0.5 % hyperbaric bupivacaine + 10 microgram fentanyl. 
Intervention  Height and weight based dosage of bupivacaine  Single shot Subarachnoid block with 0.5 % hyperbaric bupivacaine based on height and weight (using Hartens chart) + 10 microgram fentanyl 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1) Patient undergoing elective LSCS
2) Age 18-40 yrs
3) ASA II patients
4) Weight 50-90 kg
5) Height 140cm-180cm
6) Singleton pregnancy
 
 
ExclusionCriteria 
Details  1) Emergency caesarean section
2) Patients refusing spinal anesthesia
3) Infection at the site of regional blockade
4) Bleeding diathesis
5) Hypersensitivity to the study drug
6) Allergy to local anaesthetics
7) Neurological diseases
8) Spinal deformities
 
 
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 heart rate and blood pressure between the fixed dose of bupivacaine and bupivacaine based on Hartens chart  Baseline, pre-spinal, post-spinal, 5mins, 15mins, 30mins, 60 mins, 120 mins, post anesthesia care unit 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of onset of sensory blockade in both the groups

 
every 30 seconds upto 10 minutes 
comparison of motor regression time  every 15 minutes 
comparison of sensory regression  every 15 minutes 
quality of block assessed by surgeon   after surgery 
quality of Intraoperative analgesia assessed by patient   once after surgery 
APGAR score of baby  after baby delivery and at 5 minutes after delivery 
complications  every 10 minutes  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/07/2022 
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="6"
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 - NO
Brief Summary   The preferred choice of anaesthesia for conducting emergency and elective caesarean section is spinal considering the various physiological changes in pregnancy. Hypotension still persists as a major problem during spinal anaesthesia. 
Various strategies employed to prevent hypotension are preloading with intravenous fluid, leg elevation, prophylactic administration of vasopressors, using lower dose of local anaesthetic agents, use of additives like clonidine, opioids etc.
The dose of bupivacaine is reduced in obstetric patients due to increased sensitivity of neural tissue, alteration in CSF volume, weight gain and exaggerated lordosis. As a result of these factors which ultimately result in significant cephalad spread resulting in higher level of blockade causing maternal discomfort and hypotension. 
The dose of bupivacaine for patients undergoing LSCS under spinal is around 12mg (12.78 mg for normal weight and 11.86 mg for obese population). Studies have proved that dose of bupivacaine based on height for spinal anaesthesia in LSCS patients is 0.06mg/cm.
The use of 8-10mg bupivacaine has been associated with lesser incidences of hypotension but greater intraoperative need for analgesia to dampen the pain.
This results in a wide range of dose of bupivacaine administered to these patients. 
The purpose of this study is to analyze the characteristics of block achieved with height and weight adjusted dose of bupivacaine with fentanyl versus a fixed dosage of bupivacaine with fentanyl in elective caesarean section patients so as to find the optimum dose of drug required for adequate anaesthesia, which in turn will reduce the usage of vasopressors.
 
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