| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
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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.
|