FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/08/056548 [Registered on: 16/08/2023] Trial Registered Prospectively
Last Modified On: 15/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of haemodynamic parameters following two regimes of fractionated doses of Levobupivacaine in lower segment caesarean section under spinal anaesthesia.  
Scientific Title of Study   Comparative evaluation of haemodynamic parameters following two regimes of fractionated doses of levobupivacaine for spinal anaesthesia in patients of lower segment caesarean section -A randomized, comparative, controlled study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krishna Lakhmani 
Designation  PG Resident 
Affiliation  Department of Anaesthesia,School of Medical Sciences and Research and Sharda Hospital  
Address  Department of Anaesthesia, School of Medical Sciences and Research and Sharda Hospital Greater Noida ,Gautam Buddha Nagar, Uttar Pradesh 201310 India
Greater Noida ,Gautam Buddha Nagar, Uttar Pradesh 201310 India
Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9839963805  
Fax    
Email  krishnalakhmani21@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mahendra Kumar 
Designation  Professor 
Affiliation  Department of Anaesthesia,School of Medical Sciences and Research and Sharda Hospital  
Address  Department of Anaesthesia,School of Medical Sciences and Research and Sharda Hospital Greater Noida ,Gautam Buddha Nagar, Uttar Pradesh 201310 India
Greater Noida ,Gautam Buddha Nagar, Uttar Pradesh 201310 India
Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9839963805  
Fax    
Email  mahendramohit@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mahendra Kumar 
Designation  Professor 
Affiliation  Department of Anaesthesia,School of Medical Sciences and Research and Sharda Hospital  
Address  Department of Anaesthesia,School of Medical Sciences and Research and Sharda Hospital Greater Noida ,Gautam Buddha Nagar, Uttar Pradesh 201310 India
Greater Noida ,Gautam Buddha Nagar, Uttar Pradesh 201310 India

UTTAR PRADESH
201310
India 
Phone  9839963805  
Fax    
Email  mahendramohit@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia,School of Medical Sciences and Research and Sharda Hospital  
 
Primary Sponsor  
Name  Department of Anaesthesia,School of Medical Sciences and Research and Sharda Hospital  
Address  plot no. 32,34,knowledge park 3, Greater Noida ,Gautam Buddha Nagar, Uttar Pradesh 201310 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 Krishna Lakhmani  School of Medical Sciences and Research and Sharda Hospital   Department of Anaesthesia, second floor, B block
Gautam Buddha Nagar
UTTAR PRADESH 
9839963805

krishnalakhmani21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, School of Medical Sciences and Research,Sharda University, Greater Noida  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 
Intervention  Comparative evaluation of haemodynamic parameters following two regimes of fractionated doses of levobupivacaine for spinal anaesthesia in patients of lower segment caesarean section-A randomized, comparative, controlled study   Three groups are taken with a total sample size of 105(35 in each group).The drug Levobupivacaine 0.5% heavy calculated as 0.07 mg/cm of the patient’s height will be given in all three groups in different manner. Group 1:Total calculated dose of levobupivacaine 0.5% heavy as single bolus dose. Group 2:Total calculated dose of levobupivacaine 0.5% heavy as two fractionated doses one-third followed by two third with a gap of 90 sec. Group 3:Total calculated dose of levobupivacaine 0.5% heavy as two fractionated doses two-third followed by one-third with a gap of 90 sec. Dose-Fractionated Frequency-one time for spinal anaesthesia Route of administration -Intrathecal total Duration-Perioperatively approx 4 hours  
Comparator Agent  N/A  N/A 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1. Patients scheduled for LSCS under spinal anaesthesia
2. ASA class II
3. Age 18-35 years
4. Height-140-170cms
5. BMI<30kg/m2
6. Uncomplicated singleton pregnancies
7. Patient having systolic blood pressure between 110-130mm of Hg

 
 
ExclusionCriteria 
Details  1. Patient having history of any systemic illness of cardiovascular system, respiratory system, endocrine, renal or hepatic disorders.
2. Fetal distress (as diagnosed by obstetrician)
3. BMI >30% kg / m2

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the number of patients requiring mephentermine to maintain systolic blood pressure ±20% of baseline value in three groups. (Two groups of fractionated doses & one group of bolus dose).

 
Perioperatively till 2 hours in same setting

 
 
Secondary Outcome  
Outcome  TimePoints 
To compare total requirement of mephentermine among three groups
To compare haemodynamic parameters HR SBP DBP MAP
To compare time of onset & regression of sensory & motor block in three
groups
To compare neonatal outcome by APGAR score at 1 min 5 min & 10 min
 
Till 2 hours post operative period 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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   Phase 3 
Date of First Enrollment (India)   31/08/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Spinal anaesthesia is a commonly practiced anaesthetic technique in patients  undergoing elective or emergency lower segment caesarean sections. It is a safe, cost effective and easy to perform technique which provides a denser block and so more preferred. It also avoids  the various complications of general anaesthesia like stress response, airway management, post-operative nausea and vomiting and thereby facilitates earlier resumption of feeding and mobilization. Spinal anaesthesia has a quick onset and provides satisfactory sensory and motor blockade. Administration of the appropriate choice and dose of local anaesthetic into the  subarachnoid space results in rapid onset of deep spinal anaesthesia with a greater degree of success .The rapidity of onset of spinal block is advantageous in cases where delivery of the foetus needs to be hastened  due to compromised fetal state.1

The required dosage of effective block for LSCS has been associated with maternal arterial hypotension of 60-90% with maternal and neonatal morbidity2. The haemodynamic stability and prolonged duration of analgesia were observed by injecting the local anaesthetic drug in divided doses into the subarachnoid space.3-5

Spinal anaesthesia(SA) has rapid onset and is associated with various problems e.g. bradycardia , hypotension . Maternal hypotension may lead to decrease in uteroplacental perfusion which may result in fetal acid base imbalance, maternal nausea and vomiting and may be an important contributory factor for maternal morbidity related to regional anaesthesia.1 Maternal hypotension and subsequent consequences are reduced to some extent by various measures like preloading or coloading of crystalloids or colloids , low dose local anaesthetic, left uterine displacement, prophylactic use of vasopressors etc but with reduction in incidence and severity of hypotension..

Several factors like height, weight, pregnancy and anatomical changes influence the dose of local anaesthetic drug for  its intensity and duration of spinal block. Many physiological and anatomical changes during pregnancy affect spinal anaesthesia. The hormonal and mechanical factors make pregnant women require less local anaesthetic than non-pregnant women to attain same level of spinal anaesthesia.6

Levobupivacaine is an effective long acting amide local anaesthetic and is an S enantiomer of racemic bupivacaine , since it does not conatin R isomer , cardiotoxicity and neurotoxicity is lesser than bupivacaine. 

In this regard, in addition to above mentioned measures, fractionated doses of local anaesthetic for spinal anaesthesia has been used to assess its effect on haemodynamic parameters in caesarean section.

In these studies, a fraction of two-third of calculated dose of local anaesthetic followed by one-third was used for spinal anaesthesia, with the incidence of hypotension during spinal anaesthesia in about 16 % patients as compared to 46% patients who had hypotension with non fractionated doses (bolus doses).

Extensive search of literature did not show any study comparing the two fractionated doses (one -third followed by two-third versus two-third followed by one-third) of local anaesthetic agent for spinal anaesthesia in the patients of caesarean section.

In the present study, haemodynamic parameters will be compared in spinal anaesthesia induced with either of two regimes of fractionated doses (one -third followed by two-third versus two-third followed by one-third ) or single bolus dose of Levobupivacaine 0.5% Heavy  in patients of caesarean section.


 
Close