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CTRI Number  CTRI/2024/08/072089 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 07/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Adjusting local anaesthetic levels in spinal anaesthesia for safer and more comfortable ceasarean section- A study 
Scientific Title of Study   Efficacy of level adjusted local anaesthetic dose for subarachnoid block in elective caesarean section -A randomised trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Balaji Chenthil 
Designation  Postgraduate 
Affiliation  SBV Deemed to be university 
Address  Department of anaesthesiology, Mahatma Gandhi Medcal College, Pondicherry.

Pondicherry
PONDICHERRY
607403
India 
Phone  8220191465  
Fax    
Email  balajichenthil@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Parthasarathy S 
Designation  Professor 
Affiliation  SBV deemed to be university 
Address  Department of anaesthesiology, Mahatma Gandhi Medical College, Pondicherry.

Pondicherry
PONDICHERRY
607403
India 
Phone  9443142582  
Fax    
Email  painfreepartha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Balaji Chenthil 
Designation  Postgraduate 
Affiliation  SBV Deemed to be university 
Address  Department of anaesthesiology, Mahatma Gandhi Medical College, Pondicherry.

Pondicherry
PONDICHERRY
607403
India 
Phone  8220191465  
Fax    
Email  balajichenthil@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology, Mahatma Gandhi Medical College, Pondicherry-607402,India 
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College 
Address  Department of anaesthesiology, Mahatma Gandhi Medical College, Pondicherry-607402,India 
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 Balaji Chenthil  Mahatma Gandhi Medical College  Department of anaesthesiology, Mahatma Gandhi Medical College, Pondicherry.
Pondicherry
PONDICHERRY 
8220191465

balajichenthil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee,MGMCRI,Puducherry-607402  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Spinal anaesthesia with Inj.0.5% Hyperbaric Bupivacaine  Spinal level - L2-L3 - 2ml of the drug given intrathecally  
Comparator Agent  Spinal anaesthesia with Inj.0.5% Hyperbaric Bupivacaine  Spinal level - L3-L4 - 2.2ml of the drug given intrathecally 
Comparator Agent  Spinal anaesthesia with Inj.0.5% Hyperbaric Bupivacaine  Spinal level - L4-L5 - 2.4ml of the drug given intrathecally 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Term pregnancy (37 weeks)
2.Category IV - Planned for elective LSCS
3.Category III - Needing early delivery but no fetal or maternal compromise
4.Height more than 150 cms
5.ASA II
6.Singleton pregnancy 
 
ExclusionCriteria 
Details  1.Hypertensive disorder complicating pregnancy
2.Cardiovascular illness
3.Fetal abnormalities
4.Height more than 180 cms
5.BMI more than 35
6.Other contraindications for spinal anaesthesia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To estimate the incidence of hypotension following subarachnoid block with three different doses of bupivacaine at three different levels.  At 1,2,4,6,8,10,12,15,20,25,30,35,40,60,90 minutes following subarachnoid block 
 
Secondary Outcome  
Outcome  TimePoints 
To estimate the spinal level achieved, time to achieve the level, total vasopressor required.  At 1,2,4,6,8,10,12,15,20,25,30,35,40,60,90 minutes following subarachnoid block 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   26/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  26/08/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

All parturients  of category IV will be  pre-medicated with tablet pantoprazole 40mg and  tablet perinorm 10mg night before and morning of surgery. Parturients belonging to category III will receive oral pantoprazole 40 mg two hours prior to surgery. A 18 gauge intravenous cannula will be inserted and standard monitoring such as non-invasive blood pressure ,saturation and ecg will be established. The base line vitals will be recorded. The patient will then be placed in lateral position. Pre-procedural ultrasound scanning will be done to identify the respective interspace. Then subarachnoid blockade will be administered using 25 g quincke’s needle in group A with 2ml of 0.5% hyperbaric bupivacaine in L2-L3 space , group B with 2.2ml of 0.5%bupivacaine in L3-L4 space, in group C 2.4ml of 0.5%bupivacaine in L4-L5 space. Drug will be loaded in 2.5ml syringe and will be administered at the rate of 0.2ml/sec. All the patients will be coloaded with intravenous crystalloids at 15ml/kg after the administration of intrathecal bupivacaine. Then patient will be placed in supine position. Wedge will be placed for all patients. Supplemental oxygen will be given with face mask at 6l/min. Sensory block assessment will be done with pinprick method and motor assessment will be done by bromage assessment. Desired spinal level is T4-T6. Manoeuvres required to achieve the spinal level such at head down(Trendelenburg position) will be noted. Time taken to achieve the desired level will also be noted. Hemodynamic parameters will be measured at 0,1,2 minutes  and  there after every 2 minutes for the first 15minutes. Then after every 5minutes till the end of surgery. 0 minute is defined  as the time of removal of spinal needle. Surgery will be proceeded and after the delivery of the baby 20 international units of oxytocin intravenously will be administered. Delivery time , weight and apgar score of the baby will be noted. Hypotension is defined as 20% decrease in blood pressure from the baseline or systolic blood pressure less than 90mmhg. Bradycardia is defined as 20% decrease in heart rate from baseline or less than 50 beats/minute. Hypotension will be treated with intravenous ephedrine 6mg bolus dose and total dose required will be noted. Bradycardia will be treated with intravenous atropine 0.6mg and will be noted. Incidence of dizziness, nausea and vomiting due to maternal hypotension will also be noted. At the end of surgery blood loss and total intravenous crystalloids used will be noted. All patients will receive 2 mcg/kg of intravenous fentanyl after the delivery of the baby and intravenous paracetamol1g during skin closure. Patients who require more than three attempts for spinal anaesthesia and patients with insufficient sensory blockade at the end of 10mins, general anaesthesia will be administered and patients will be excluded from the study.By using the ultrasound ,the space cannot be identified,then the patient will be excluded from the study.

 
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