| CTRI Number |
CTRI/2020/07/026635 [Registered on: 17/07/2020] Trial Registered Prospectively |
| Last Modified On: |
01/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The usefullness of the ultrasound scanning of the spine before spinal anaestehsia |
|
Scientific Title of Study
|
A comparative study of the role and utility of pre-procedural ultrasound
scanning in location of the subarachnoid space versus the conventional landmark technique
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nita Dsouza |
| Designation |
Consultant Anesthesiology |
| Affiliation |
Ruby hall clinic, pune |
| Address |
Department of Anaesthesia
Ruby Hall Clinic,
40, Sassoon Road,
Camp,
Pune-411001
Pune
MAHARASHTRA
411001
India |
| Phone |
09823721982 |
| Fax |
|
| Email |
drnita610@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nita Dsouza |
| Designation |
Consultant Anesthesiology |
| Affiliation |
Ruby hall clinic, pune |
| Address |
Department of Anaesthesia
Ruby Hall Clinic,
40, Sassoon Road,
Camp,
Pune-411001
MAHARASHTRA
411001
India |
| Phone |
09823721982 |
| Fax |
|
| Email |
drnita610@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nita Dsouza |
| Designation |
Consultant Anesthesiology |
| Affiliation |
Ruby hall clinic, pune |
| Address |
Department of Anaesthesia
Ruby Hall Clinic,
40, Sassoon Road,
Camp,
Pune-411001
MAHARASHTRA
411001
India |
| Phone |
09823721982 |
| Fax |
|
| Email |
drnita610@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
Ruby Hall Clinic has provided the USG machine for which consultants ar eregistered through an affidavit with the local city corporation |
|
|
Primary Sponsor
|
| Name |
Nita Dsouza |
| Address |
Department of Anaesthesia
Ruby Hall Clinic,
40, Sassoon road,
Camp
Pune |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Nita Dsouza |
Ruby Hall cLinic, Pune |
Department of Anaesthesia
Ruby Hall Clinic,
40, Sassoon road,
Camp
Pune-411001
Pune
MAHARASHTRA |
09823721982
drnita610@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| POONA MEDICAL RESEARCH FOUNDATION |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Posted for surgeries under spinal anaesthesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound scanning |
One group will be subjected to scanning by the ultrasound in a orderly fashion to note level of SAB, depth of the subarachnoid space and direction of the needle for an uniterrupted trajectory.
This is done at the start of surgery before administering the spinal anaesthetic and time will be noted for scanning and achieving a successful CSF in the spinal needle. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ALL patients fit for Spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients not willing for spinal Anaesthesia
Paeditric age group
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Time taken for ultrasound scanning nooted U1
-Time taken for needle to CSF noted U2
-Number of needle passes
-Attempts taken |
after scanning |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect of BMI on duration
-Difference of time taken by resident and consultant |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
24/07/2020 |
| 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="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Spinal anaesthesia is conventionally performed with
landmark-guided midline approach. Ultrasound (USG) aid prior to attempting the puncture may
help identifying the correct space, midline, angle of entry and may hypothetically reduce the number of attempts and increase success rates. USG scanning prior may prove to be beneficial when difficult surface
landmarks or with abnormal anatomy. Insufficient data to support the routine use of USG in all
patients |