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CTRI Number  CTRI/2022/01/039578 [Registered on: 19/01/2022] Trial Registered Prospectively
Last Modified On: 19/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison of skin to subarachnoid space distance as assessed by ultrasound depth in standard paramedian approach with needle insertion 1cm lateral and 1cm caudal to spine process and modified paramedian approach with entry point 1cm lateral spinal block in patients age 50 years or above 
Scientific Title of Study   A prospective randomized comparison of preprocedural ultrasound assisted standard paramedian and modified paramedian techniques for subarachnoid block in 50 years or above patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anu 
Designation  Junior resident  
Affiliation  Indira Gandhi Medical College Shimla  
Address  Junior resident Department of Anaesthesiology Indira Gandhi Medical College Shimla Himachal Pradesh 171001 India

Shimla
HIMACHAL PRADESH
171001
India 
Phone  7018019065  
Fax    
Email  anurana1509@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arti Sharma 
Designation  Associate Professor 
Affiliation  Indira Gandhi Medical College Shimla  
Address  Department of Anaesthesiology Indira Gandhi Medical College Shimla Himachal Pradesh 171001 India

Shimla
HIMACHAL PRADESH
171001
India 
Phone  9418299888  
Fax    
Email  aartisharma309@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arti Sharma 
Designation  Associate Professor 
Affiliation  Indira Gandhi Medical College Shimla  
Address  Department of Anaesthesiology Indira Gandhi Medical College Shimla Himachal Pradesh 171001 India

Solan
HIMACHAL PRADESH
171001
India 
Phone  9418299888  
Fax    
Email  aartisharma309@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, IGMCH, Shimla, Himachal Pradesh  
 
Primary Sponsor  
Name  Dr Anu 
Address  Junior resident Department of anaesthesia IGMC Shimla  
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 
Dr Anu  Indira Gandhi Medical College Hospital Shimla   Department of Anaesthesia Block c Indira Gandhi Medical College Hospital Shimla
Shimla
HIMACHAL PRADESH 
7018019065

anurana1509@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee IGMC Shimla   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  Preprocedural ultrasound assisted subarachnoid block in patients age 50 years or above by modified paramedian approach   Subarachnoid block shall be given by modified paramedian approach in which needle will be insert 1cm lateral to spinous process  
Intervention  Preprocedural ultrasound assisted subarachnoid block in patients age 50 years or above by standard paramedian approach   Subarachnoid block shall be given by standard paramedian approach in which needle will be insert1cm lateral and 1cm caudal to spinous process  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients 50 year or above posted for infra umbilical surgery and willing to participate in study  
 
ExclusionCriteria 
Details  Patients refusal for spinal anaesthesia or unwilling to participate in the study
Patients allergic to local anaesthetics
Local infection or scarring at the site of needle insertion
Patients with spinal deformities congenital or acquired and previous spine surgery
Any history of bleeding disorders
Any complication or adverse events during previous surgery under spinal anaesthesia
Patients with morbid obesity  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of number of attempts in standard paramedian approach needle insertion 1cm lateral and 1cm caudal to spinous process and modified paramedian approach with entry point 1cm lateral to spinous process




 
0 minute



 
 
Secondary Outcome  
Outcome  TimePoints 
1. Comparison of Preprocedural ultrasound measured depth for needle insertion for spinal anaesthesia and actual depth of needle insertion while administration of spinal anaesthesia using standard paramedian approach and modified paramedian approach
2. Comparison of first attempt success rate in both paramedian groups
3.Comparison of incidence of bloody tap in both groups
4.Comparison of incidence of paraesthesia in both groups
5.Comparison of incidence of post rural puncture headache in both groups within 24 hours postoperatively 
Baseline  
 
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)   20/01/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [anurana1509@gmail.com].

  6. For how long will this data be available start date provided 13-11-2023 and end date provided 29-11-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Title of the project: A Prospective randomized comparison of preprocedural ultrasound assisted standard paramedian and modified paramedian technique of subarachnoid block in patients 50 years or above.
Primary objective:
Comparison of number of attempts of in standard paramedian approach (needle insertion 1cm lateral and 1cm caudal to spinous process) and modified paramedian approach with entry point 1cm lateral to spinous process.
2 Comparison of preprocedural ultrasound measured depth for needle insertion for spinal anaesthesia and actual depth of needle insertion while administrations of spinal anaesthesia using standard paramedian approach and modified paramedian approach.
3 Comparison of first attempt success rate in both paramedian groups.
Secondary objective:
1 Comparison of incidence of incidence of bloody tap in both groups.
2 Comparison of incidence of paraesthesia in both groups.
3 Comparison of incidence of post dural puncture headache in both groups within 24 hours postoperatively.
Spinal anaesthesia is most preferred technique for elderly patients with multiple comorbidities. Directing the needle into the vertebral canal is sometimes difficult in elderly patients because of narrow interspinous and interlaminar spaces. Preprocedural ultrasound scanning of spine before spinal anaesthesia help to overcome the common limitations like multiple attempts, postdural puncture headache, bloody tap and neurological injuries.
On reviewing the literature we could find that there is no consensus whether which approach is better or gold standard. There are many studies which comparing midline and paramedian approach but review of literature reveal very few or limited studies comparing preprocedural ultrasound assisted paramedian approach in elderly patients. Hence this particular study was undertaken.

 
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