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CTRI Number  CTRI/2023/08/056313 [Registered on: 09/08/2023] Trial Registered Prospectively
Last Modified On: 07/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational analytical study 
Study Design  Other 
Public Title of Study   Comparing ultrasound method and landmark method for administering spinal anaesthesia in caesarean section 
Scientific Title of Study   Comparison of ultrasound and landmark technique for subarachnoid block in caesarean section 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pooja Sunil Pai 
Designation  Junior resident 
Affiliation  K S Hegde medical academy 
Address  Department of Anaesthesiology and critical care, K S Hegde medical academy, P.O Nityanandagar, Deralakatte, Mangaluru, Karnataka 575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9130531621  
Fax    
Email  pooja396pai@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sripada G Mehandale 
Designation  HOD and professor 
Affiliation  K S Hegde medical academy 
Address  Department of Anaesthesiology and critical care, K S Hegde medical academy, P.O Nityanandagar, Deralakatte, Mangaluru, Karnataka 575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448384310  
Fax    
Email  sripadamehandale@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Sripada G Mehandale 
Designation  HOD and professor 
Affiliation  K S Hegde medical academy 
Address  Department of Anaesthesiology and critical care, K S Hegde medical academy, P.O Nityanandagar, Deralakatte, Mangaluru, Karnataka 575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448384310  
Fax    
Email  sripadamehandale@nitte.edu.in  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and critical care, K S Hegde medical academy, P.O Nityanandagar, Deralakatte, Mangaluru, Karnataka 575018 
 
Primary Sponsor  
Name  Sunil Pai 
Address  Saiveda, Matadakani 5th cross, Ashoknagar, Mangalore 
Type of Sponsor  Other [Self] 
 
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 
Pooja Sunil Pai  K S Hegde medical academy  Department of Anaesthesiology and critical care, P.O Nityanandagar, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA 
9130531621

pooja396pai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, K S Hegde medical academy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80-O82||Encounter for delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1)Pregnant women aged 18-35 years of age
2)Undergoing elective LSCS under spinal anaesthesia
 
 
ExclusionCriteria 
Details  1)Patients in labour
2)Difficulty maintaining proper position
3)Patients with infection at the site of spinal injection
4)Patients with a bleeding disorder or coagulopathy
5)Patients with cardiovascular diseases like rheumatic heart disease, mitral regurgitation, and mitral stenosis who are not on treatment
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare ultrasound guided & landmark technique in terms of success rate  Preparation time - the time taken by the anaesthesiologist from palpation the of iliac crest or placement of ultrasound probe over the back till the needle insertion
Procedural time - the time taken from the insertion of the spinal needle until the free flow of CSF
 
 
Secondary Outcome  
Outcome  TimePoints 
1)To measure the time taken to administer spinal anaesthesia in each group
2)To measure the distance from the skin to subarachnoid space
3)To assess patient satisfaction
4)To compare the occurrence of post-dural puncture headache 
Preparation time - the time taken by the anaesthesiologist from palpation the of iliac crest or placement of ultrasound probe over the back till the needle insertion
Procedural time - the time taken from the insertion of the spinal needle until the free flow of CSF
 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   18/08/2023 
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="0"
Months="6"
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  

The subarachnoid block is a safe and effective alternative to general anaesthesia when the surgical site is on the lower abdomen, perineum, or lower extremities. Spinal anaesthesia is  the preferred regional technique for caesarean section due to its ease of administration with a high success rate and rapid onset of anaesthesia. Spinal anaesthesia for caesarean section is commonly delivered using the traditional landmark technique where we palpate bony anatomical landmarks i.e the iliac crests and spinous processes to locate the L4-L5 intervertebral space.

 

The proposed ideal site for spinal anaesthesia is below the Conus medullaris. In adults, Conus  medullaris ends at the lower border of the body of L1 vertebrae in the majority of the population. It has been reported that there is an increased incidence of neurological trauma following spinal anaesthesia if performed at the vertebral level where conus medullaris ends. Neurological trauma is seen more in the obstetric population due to the variation in normal anatomy that occurs during pregnancy. Variations in the normal anatomy of the vertebral column in pregnancy can also make it difficult for anaesthesiologists in locating the intervertebral space. The physical changes that occur in pregnancy are-

1)Lumbar lordosis

2)Rotation of pelvis to the long axis of the spinal column

3)Weight gain


All of the above would lead to difficulty in estimation of intervertebral space via landmark technique. The advantages of ultrasound guidance over conventional techniques include the ability to both view the targeted structure and visualize, in real-time the distribution of the injected medication, and the capacity to control its distribution by readjusting the needle position if needed. USG guidance should plausibly improve the success rate of the procedures, their safety and speed. For locating the L4 L5 intervertebral space, USG of the spine appears to help increase the success of the subarachnoid block. It is non-invasive and hence will be safe for pregnant women, radiation-free and known to her from early on in pregnancy. In this study, we are going to assess if a USG-assisted technique could reduce the time taken for the procedure, number of needle passes required for identifying subarachnoid space and if there is any correlation with post- dural puncture headache using the USG technique when compared to landmark guided  technique in pregnant women.

 

After approval from the Institutional Ethics committee and with informed and written consent, pregnant women who will undergo landmark guided technique will be considered as group L and the ones who will undergo ultrasound-guided technique will be considered as group U.

Procedure-related definitions are given below:

1.Preparation time: the time taken by the anaesthesiologist from palpation the of iliac crest or placement of ultrasound probe over the back till the needle insertion.

2.Procedural time: the time taken from the insertion of the spinal needle until the free flow of CSF

3.Success rate: Obtaining CSF flow.

4.Attempts: insertion of a spinal needle into the skin

5.Passes: redirecting the spinal needle in the same space or different space without exiting the skin.

6. Patient satisfaction score: At the end of the surgery, patients will be queried for satisfaction and made to mark intraoperative anaesthetic satisfaction on a four-point Likert scale (1 – Not satisfactory, 2 – Satisfactory, 3 – Good, 4 – Excellent) based on the number of needle pricks, pain at the site of injection, intraoperative analgesia, and sedation

7. Post dural puncture headache: Bilateral frontal or occipital headache that is worse in the upright position, along with nausea, neck pain, dizziness, visual changes, tinnitus, hearing loss, or radicular symptoms in the arms.

8.Distance from the skin to subarachnoid space- measurement of the distance from the skin to the ventral border posterior complex on the ultrasound or length of the needle inside the body on successful attempt as measured using a scale after spinal anaesthesia

Standard fasting protocols will be followed in all the patients. Intravenous cannulation will be  established and oral premedication with a tab. Pantoprazole 40mg would be given on the previous day and before the procedure. Patients would then be shifted to the operating room  in the left lateral position. Inside the operation theatre, standard monitoring in the form of non-invasive blood pressure, electrocardiogram, and pulse oximetry will be instituted and the baseline parameters will be recorded. All participants, after noting down baseline parameters, will be made to lie in the left lateral decubitus position, in group L under aseptic precautions L3-L4 or L4-L5 intervertebral space will be identified using the landmark technique by palpating the space that corresponds to Tuffier’s line, and in this space, local infiltration will be given, after this spinal anaesthesia will be administered. In group U, a sterile cover will be applied to the curvilinear USG probe. A parasagittal view of the spine will be obtained, and then the L3–L4 intervertebral space will be identified by moving up from the sacrum below. At this selected L3–L4 intervertebral space, the probe position will be changed to a transverse view and brought to the midline. After identifying the L3–L4 space, the best image of the anterior complex and posterior complex will be obtained, and a sterile surgical skin marker will be used to mark the midpoint of the long and short borders of the probe in the midline. The point of intersection between the two perpendicular lines will be identified as the point of entry. Then local infiltration and spinal anaesthesia will be given at the marked point. Conventionally trained anaesthesiologists who are experienced in identifying posterior cord structures using ultrasound will be performing the procedure. In both groups, the procedural time, preparation time, number of attempts in the same space and different spaces, number of passes, distance of subarachnoid space from the skin, patient satisfaction score will be measured. The dosage of local anaesthetic will be kept standard between the groups as 10mg of 0.5% hyperbaric Bupivacaine. In both groups, the primary outcome will be the success rate. The secondary outcomes will be the time taken to administer spinal anaesthesia,the distance from the skin to subarachnoid space, patient satisfaction and occurrence of post-dural puncture headache. At the end of the surgery, patients will be queried for satisfaction and made to mark intraoperative anaesthetic satisfaction on a four-point Likert scale. Patients will be followed up for 7 days, if patient is discharged before completion of 7 days, a follow up till the 7th day will be done via telephone.

 
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