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CTRI Number  CTRI/2025/04/084136 [Registered on: 04/04/2025] Trial Registered Prospectively
Last Modified On: 27/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   Relationship of distance from skin to fluid filled space around the spinal cord with body mass index in patients undergoing surgeries below the level of umbilicus under an anaesthetic technique in which the medication is injected into the fluid filled space around spinal cord. 
Scientific Title of Study   Correlation between skin to subarachnoid space distance and Body Mass Index in patients undergoing infraumbilical surgeries under spinal anaesthesia–A Prospective Observational 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  Dr Ajay Kumar 
Designation  Senior Specialist & HOD 
Affiliation  Deen Dayal Upadhyay Hospital, Govt of NCT of Delhi 
Address  Dept of Anaesthesiology & Critical Care, Deen Dayal Upadhyay Hospital, HariNagar, New Delhi

West
DELHI
110064
India 
Phone  9718990114  
Fax    
Email  ajayannu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dheeraj Pandey 
Designation  Primary DNB 
Affiliation  Deen Dayal Upadhyay Hospital, Govt of NCT of Delhi 
Address  Dept of Anaesthesiology & Critical Care, Deen Dayal Upadhyay Hospital, HariNagar, New Delhi

West
DELHI
110064
India 
Phone  9899898676  
Fax    
Email  docdheerajpandey@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Upasana Goswami 
Designation  Specialist Grade I 
Affiliation  Deen Dayal Upadhyay Hospital, Govt of NCT of Delhi 
Address  Dept of Anaesthesiology & Critical Care, Deen Dayal Upadhyay Hospital, HariNagar, New Delhi

West
DELHI
110064
India 
Phone  9718990118  
Fax    
Email  upagoswami@gmail.com  
 
Source of Monetary or Material Support  
Deen Dayal Upadhyay Hospital, Govt of NCT of Delhi 
 
Primary Sponsor  
Name  Deen Dayal Upadhyay Hospital 
Address  Dept of Anaesthesiology & Critical Care, Deen Dayal Upadhyay Hospital, HariNagar, New Delhi, 110064 
Type of Sponsor  Research institution and hospital 
 
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 Ajay Kumar  MOT-1, MOT-2, Trauma Em OT Deen Dayal Upadhyay Hospital  Dept of Anaesthesiology & Critical Care, Deen Dayal Upadhyay Hospital, HariNagar, New Delhi, 110064
West
DELHI 
9718990114

ajayannu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Deen Dayal Upadhyay Hospital  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 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All patients of ASA I/II category undergoing infraumbilical surgeries under spinal anaesthesia. 
 
ExclusionCriteria 
Details  1.History of allergy to bupivacaine.
2.Spinal deformity.
3.Failure to perform lumbar puncture at L3-L4 intervertebral space in the midline.
4.Pregnant patients.
5.Other than the midline approach for spinal anesthesia
6.Patient with oedema at the site of spinal anesthesia
7.Patient with previous lumbar spine surgeries.
8.Patients for whom the angle of spinal needle was not perpendicular 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To analyse the correlation between skin to subarachnoid space distance and body mass index in patients undergoing infraumbilical surgeries under spinal anaesthesia.  After giving the intrathecal injection the depth of spinal needle insertion will be measured and noted using a vernier caliper. 
 
Secondary Outcome  
Outcome  TimePoints 
To analyse the correlation between skin to subarachnoid space distance with age,gender,height and weight in patients undergoing infraumbilical surgeries under spinal anaesthesia.  After giving the intrathecal injection the depth of spinal needle insertion will be measured and noted using a vernier caliper. 
 
Target Sample Size   Total Sample Size="37"
Sample Size from India="37" 
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)   07/04/2025 
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="4"
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  

Background: Various factors including anthropometric measurements are known to affect the skin to subarachnoid distance. Out of these, certain anthropometric values such as BMI, weight and height can be easily measured and are helpful in predicting the depth of spinal needle to be inserted.

 

Aim: The Aim of our study is to evaluate the correlation between skin to subarachnoid distance and BMI.

 

Setting and Design: This Prospective observational study will be conducted at Deen Dayal Upadhyay Hospital, New Delhi after obtaining approval from the Scientific Research committee, Institutional Ethics Committee and written informed consent of participating patients.

 

Material and Methods: Thirty-Seven patients fulfilling the inclusion criteria undergoing infraumbilical surgeries under spinal anaesthesia will be enrolled in the study. Preoperatively, patient will be explained in detail about the procedure to be performed and anthropometric measurements of the patient like height, weight and BMI which are required for the study will be taken. Using a 25G Quincke’s needle, 3 ml of 0.5 % hyperbaric bupivacaine will be administered intrathecally to the patient in a sitting position at L3-L4 interspace. After giving the intrathecal injection, the spinal needle will be marked using a sterile skin-marking pen then grasped firmly between the thumb and the index finger abutting the patient’s back and removed. The depth of spinal needle insertion will be measured using a vernier caliper.

 

Statistical Analysis:  Spearman/Pearson correlation will be used to determine the statistical significance between skin to subarachnoid distance and BMI. For all statistical tests, a p value less than 0.05 will be taken to indicate a significant difference

 

Conclusion: This study will be helpful in Correlating relation between Skin to Subarachnoid space during lumbar puncture and the BMI of the patient.

 

 

 
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