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CTRI Number  CTRI/2024/08/071890 [Registered on: 05/08/2024] Trial Registered Prospectively
Last Modified On: 31/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the accuracy of using ultrasound versus landmark guided method for locating subarachnoid space in patients having cesarean delivery under spinal anaesthesia 
Scientific Title of Study   A randomized controlled study to compare the accuracy of pre-procedural ultrasound versus conventional landmark method for locating subarachnoid space in patients undergoing cesarean delivery under spinal anaesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Harsh Kaul 
Designation  PG resident 
Affiliation  Lady hardinge medical College and associated hospitals, New Delhi 
Address  Department of Anaesthesia, Lady hardinge medical college Shaheed Bhagat Singh marg Connaught place

Central
DELHI
110001
India 
Phone  9599699038  
Fax    
Email  kaulrobin12@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anshu Gupta 
Designation  Professor 
Affiliation  Lady hardinge medical college and associated hospitals , New Delhi 
Address  Department of Anaesthesia, Lady hardinge medical college, Shaheed Bhagat Singh marg, connaught place

Central
DELHI
110001
India 
Phone  9871158433  
Fax    
Email  dranshugupta1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anshu Gupta 
Designation  Professor 
Affiliation  Lady hardinge medical college and associated hospitals , New Delhi 
Address  Department of Anaesthesia, Lady hardinge medical college, Shaheed Bhagat Singh marg, connaught place


DELHI
110001
India 
Phone  9871158433  
Fax    
Email  dranshugupta1@gmail.com  
 
Source of Monetary or Material Support  
Lady Hardinge Medical College Shaheed Bhagat Singh Marg, , DIZ Area, Connaught Place, New Delhi, Delhi, India 110001 
 
Primary Sponsor  
Name  lady hardinge medical college 
Address  department of anaesthesia lady hardinge medical college shahid bhagat singh marg, connaught place  
Type of Sponsor  Government 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 harsh kaul  Lady hardinge medical college  Department of Anaesthesia, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi, Delhi 110001
Central
DELHI 
9599699038

kaulrobin12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional Ethics comittee for human research LHMC and associated hospitals, New Delhi  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 
Comparator Agent  landmark guided subarachnoid block  palpation of posterior superior iliac spine using tuffiers line and L3-L4 or L4-L5 intervertebral space.0.5% heavy bupivacine (9-10mg) with 25mcg fentanyl will be administered at an injection rate of 0.1ml/s 
Intervention  ultrasound guided subarachnoid block   L3-L4 inter vertebral space will be identified using ultrasound and pre-determined point of entry for the needle will be marked on patient’s back.0.5% heavy bupivacine (9-10mg) with 25mcg fentanyl will be administered at an injection rate of 0.1ml/s 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Patients for elective cesarean delivery as categorized by RCOG (Royal College of Obstetricians and Gynaecologists) in categories III and IV 
 
ExclusionCriteria 
Details  any contraindications of spinal anaethesia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the accuracy (in terms number of patients having successful needle first pass attempt) of pre-procedural ultrasound and conventional landmark method for locating subarachnoid space in patients undergoing cesarean delivery under spinal anaesthesia  free flow of CSF in single attempt(time noted in seconds) 
 
Secondary Outcome  
Outcome  TimePoints 
1 To compare ultrasound depth of subarachnoid space with real needle to target distance in ultrasound group
2 Number of successful needle first pass attempt in patients of various BMI
3 Number of needle redirections
4 Number of skin punctures required
5 Number of attempted intervertebral spaces
6 Total procedure time
7 Patient satisfaction using five point Likert scale after 24 hours postoperatively
8 Complications such as headache backache incidence of bloody tap 
1 measure of target distance in ultrasound to free flow of CSF in the spinal needle hub
2 free flow of CSF
3 free flow of CSF
4 free flow of CSF
5 free flow of CSF
6 free flow of CSF
7 free flow of CSF in the spinal needle hub to 24 hours post operatively
8 free flow of CSF in the spinal needle hub to 24 hours post operatively
 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/08/2024 
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="1"
Days="18" 
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 gold standard anaesthetic technique in obstetric patients because of lower complication rate and better neonatal outcome as compared to general anesthesia
However in obstetric patients there are increased lumbar lordsis, obesity and soft tissue edema making spinal anesthesia technically more challenging ,also there are many more anatomical and physiological changes in pregnancy predisposing them to multiple needle pass attempts and  increased difficulty in administrating successful subarachnoid block.
Use of landmark method of locating subarachnoid space may sometime be inaccurate, which invariably leads to repeated attempts and redirections of the needle leading to complications such as bloody tap, nerve injury, spinal hematoma, paresthesia, postdural puncture headache, patient discomfort and dissatisfaction and delay in treatment which may sometimes also affect the neonatal outcome. 
Due to challenges associated with spinal anaesthesia in obstetric patients, pre-procedural ultrasound could be helpful in locating the subarachnoid space accurately thus decreasing the number of attempts and needle redirections while performing the subarachnoid block, reducing many complications.
The existing literature explores the utility of pre-procedural ultrasound in various patient populations, but its application in obstetric anesthesia remains relatively underexplored. Therefore we planned our study in obstetric population which may guide about its utility routine practice.
Administrating spinal anaesthesia is difficult in obstetric patients due to various anatomical and physiological changes. This causes multiple needle pass attempts leading to many complications such as bloody tap, nerve injury, spinal hematoma, paresthesia, post dural puncture headache, patient discomfort and dissatisfaction.
Pre-procedural ultrasound may facilitate spinal anaesthesia by locating the accurate needle insertion point accurately in obstetric patients making the technique easier resulting in lesser needle first pass attempts, ultimately enhancing maternal and neonatal outcomes.
There is a paucity of literature regarding utility of pre-procedural ultrasound for locating sub arachnoid space in obstetric patients, its superiority over the landmark technique has not been proven yet.
 
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