| CTRI Number |
CTRI/2023/06/053434 [Registered on: 02/06/2023] Trial Registered Prospectively |
| Last Modified On: |
01/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The distance to spinal space using three modalities of measurement |
|
Scientific Title of Study
|
Comparison of the depth of Subarachnoid space using anthropometric measurements, ultrasonographic measurements and actual depth by needle insertion in a patients with BMI more than 25kg/m2 |
| Trial Acronym |
SAUN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSahil Mengaji |
| Designation |
MD Anesthesia |
| Affiliation |
KMC Hospital Mangalore |
| Address |
5th floor Department of Anesthesiology
KMC hospital,Attavar
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
8951566563 |
| Fax |
|
| Email |
Sahil.kmcmlr2022@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Julie Misquith |
| Designation |
Assistant professor ,Department of Anesthesia |
| Affiliation |
KMC Hospital Mangalore |
| Address |
5th floor Department of Anesthesiology Kasturba Medical Hospital
Attavar , Mangalore
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9945598911 |
| Fax |
|
| Email |
Juliemisquith@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
DrSahil Mengaji |
| Designation |
Year 1 of Post graduate,Department of Anesthesia |
| Affiliation |
KMC Hospital Mangalore |
| Address |
5th floor Department of Anesthesiology
Kasturba Medical College Hospital,Attavar
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
8951566563 |
| Fax |
|
| Email |
Sahil.kmcmlr2022@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Mangalore
Karnataka 575001 |
|
|
Primary Sponsor
|
| Name |
kasturba medical college |
| Address |
Kasturba Medical college hospital Attavar Mangalore 575001 |
| Type of Sponsor |
Private medical college |
|
|
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 Sahil |
Kasturba Medical College Hospital |
Department of Anesthesiology
OT complex ,5Th floor Dakshina Kannada KARNATAKA |
8951566563
sahilmengaji@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Kasturba Medical College Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
BMI more than 25kg/m2
ASA I II III and undergoing elective abdominal and lower limb surgery under spinal anesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patient not wiling to participate
2. Patients with history of spinal abnormalities
3. Patients with contraindications to regional block
4. Patients with prior complaints of low back pain
5. Patients who had previous spinal surgery
6. Patients with BMI less than 25kg/m2 and
7. Pregnant patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
i. Anthropometric measurements using Bonodio’s formula to calculate SSD
ii. Ultrasonography measurement of SSD
iii. Actual depth by needle insertion for SSD
|
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. Compare the methods
ii. The number of attempts to achieve successful spinal tap
|
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140"
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)
|
15/06/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/06/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="5" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
:
Multiple
attempts during subarachnoid block can result in complications like post dural
puncture headache, lower back pain and cause discomfort to the patient, apart
from being time consuming. Although, anatomical knowledge and technical
skills are important, presumed prearrangement of the skin to subarachnoid space
depth (SSD) may lead to the correct placement of the spinal needle. This allows
for less traumatic and fewer repetitive attempts for spinal anesthesia. The
palpation of bony landmarks required to successfully perform lumbar punctures
(LPs) can be masked in 33% of overweight patients and 68% of patients with
obesity, due to overlying soft tissue and can lead to LP failure rate of 19%. In a patient, the SSD varies considerably at different levels of the
spinal cord. It also varies from patient to patient at the same vertebral level
as per age, sex and body mass index (BMI).
The rationale behind doing this study is to assess which
method is more accurate to determine the SSD so as to minimize repeated
attempts for spinal anaesthesia especially in overweight patients. The
study is going to assess the SSD in a population with BMI>25kg/m2 with
anthropometric measurements, ultrasonography and actual depth by needle
insertion.
|