| CTRI Number |
CTRI/2025/03/083306 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of ultrasound guided scoring versus manual scoring for difficult spinal anaesthesia |
|
Scientific Title of Study
|
Evaluation of ultrasound examination scoring and manual scoring to predict difficult spinal anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Milan Singh |
| Designation |
PG Resident |
| Affiliation |
gandhi medical college bhopal |
| Address |
H BLOCK girsl hostel hamidia hospital bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
08965055927 |
| Fax |
|
| Email |
milansingh2600@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Urmila keshari |
| Designation |
Professor |
| Affiliation |
gandhi medical college bhopal |
| Address |
Department of anaesthesia gandhi medical college bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9826757745 |
| Fax |
|
| Email |
surmila19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jaideep Singh |
| Designation |
Associate Professor |
| Affiliation |
gandhi medical college bhopal |
| Address |
Department of anaesthesia gandhi medical college bhoapl
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9827767022 |
| Fax |
|
| Email |
singhdrjaideep@gmailcom |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Urmila keshari |
| Address |
Department of anesthesia Gandhi medical college bhopal |
| Type of Sponsor |
Government 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 Milan singh |
Gandhi medical college |
Department of anaesthesiology gandhi medical college bhopal
Bhopal
MADHYA PRADESH |
08965055927
milansingh2600@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Gandhi medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA GRADE 1 AND ii |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Landmark technique |
Spinal anaesthesia given via landmark technique in L3-L4 interspinous space and than compare with USG guided techniques |
| Comparator Agent |
usg guided techniques |
usg guided space finding in spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
Patient with ASA grade I and II
Patient with age group 18-60yrs
patient who recieve spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
patient contraindication to spinal anaesthesia
patient with back deformity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in number of passes between two groups |
8weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of needle insertion attempts
Time for identifying landmark
Level of block
Periprocedural pain Score
|
4weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
25/04/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Usg guided spinal anaesthesia used for for difficult spinal ,in this we compare withb landmark technique.we compare no. of attempts ,no. of passes ,time for identifying landmark,level of block,incidence of pain,paresthesia,blood in spinal needle,periprocedural pain and time for identifying spinal anaesthesia. |