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CTRI Number  CTRI/2018/12/016493 [Registered on: 03/12/2018] Trial Registered Prospectively
Last Modified On: 11/07/2023
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   Comparing two methods, that is, using a picture along with oral commands to attain correct position for spinal anaesthesia and using only oral commands to position patients for spinal anaesthesia. 
Scientific Title of Study   Optimal patient positioning for spinal anaesthesia using a visual aid in caesarean section patients: a randomized control trial.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nalini K B 
Designation  Assistant professor, Department of anaesthesiology 
Affiliation  M S Ramaiah medical college 
Address  Department of anaesthesiology M.S. Ramaiah Medical College Bengaluru

Bangalore
KARNATAKA
560054
India 
Phone  7760594547  
Fax    
Email  dr_kbnalini@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nalini K B 
Designation  Assistant professor, Department of anaesthesiology 
Affiliation  M S Ramaiah medical college 
Address  Department of Anaesthesiology M S Ramaiah Medical College Bengaluru

Bangalore
KARNATAKA
560054
India 
Phone  7760594547  
Fax    
Email  dr_kbnalini@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubha V Hegde 
Designation  Post Graduate 
Affiliation  M S Ramaiah medical college 
Address  Department of Anaesthesiology M.S.Ramaiah medical college Bengaluru

Bangalore
KARNATAKA
560054
India 
Phone  8197809917  
Fax    
Email  hegdeshubha93@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology M S Ramaiah Medical college and hospitals, Bengaluru- 560054 
 
Primary Sponsor  
Name  M S Ramaiah Medical college and Hospitals 
Address  M S Ramaiah medical college and Hospitals New Bel Road MSRIT Post Bengaluru 
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 Shubha V Hegde  M S Ramaiah medical teaching hospital  Department of anaesthesiology 2nd floor MSRMTH New Bel Road Bengaluru Karnataka
Bangalore
KARNATAKA 		 8197809917

hegdeshubha93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, MS Ramaiah Medical College and Hospitals  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  Standard verbal commands to attain optimal position for spinal anaesthesia.  Standard verbal commands (only) will be given to the patients to attain optimal position for spinal anaesthesia. 
Intervention  Visual image with 1 correct and 3 incorrect positions to be attained for spinal anaesthesia.  Visual image containing image of 1 correct position and 3 incorrect positions to be attained for spinal anaesthesia will be shown to the patients along with standard verbal commands. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.ASA II and III patients.
2.Obstetric patients undergoing caesarean section.
 
 
ExclusionCriteria 
Details  1.Patients who have prior experience with neuraxial blocks (including caesarean section or epidural labour analgesia).
2.Refusal to consent.
3.Major spinal deformities.
4.Any contraindication to neuraxial anaesthesia like, coagulopathies, infection at the site of injection, increased intracranial pressure, hypovolemia, indeterminate neurological disease, severe aortic or mitral stenosis. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To measure the duration of the time taken from giving instructions to free flow of CSF in the two groups, that is, control and study groups.
 		 Time (in seconds) will be noted from the start of giving oral and visual instructions to the patient regarding positioning for spinal anaesthesia till the free flow of CSF.
 
 
Secondary Outcome  
Outcome  TimePoints 
The total number of skin punctures, total number of inter vertebral spaces attempted and success at first attempt.  Number of skin punctures during the procedure,that is, from the start of giving instructions till the free flow of CSF will be noted. 
 
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)   17/12/2018 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Spinal anaesthesia in obstetric patients for caesarean section is one of the safest anaesthesia and has been used since many years. Spinal anaesthesia is a landmark-based technique and the most important factor in predicting the difficulty in performing spinal anaesthesia is reported to be the quality of anatomical landmarks. Apart from anatomical landmark, the adequacy of patient positioning can also predict the successful location of subarachnoid space independently.The sitting position with legs placed on the table for spinal anaesthesia is convenient to both patients and anaesthesiologists.This sitting position with knees extended may produce better reversal of lumbar lordosis, decrease frequency of bony contacts and make spinal puncture easier.This study evaluates the benefit of using visual images in addition to standard verbal instructions to optimize positioning for spinal anaesthesia in obstetric patients for caesarean section in whom positioning is difficult due to the large gravid uterus. As there are no studies regarding positioning of caesarean section patients undergoing spinal anaesthesia using a visual aid, hence the need for the study.

 
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