| CTRI Number |
CTRI/2025/11/096776 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the use of visual aid with verbal explanation in achieving the optimal patient positioning for
subarachnoid block (SAB). |
|
Scientific Title of Study
|
Evaluation of visual Aid with verbal explanation on optimal positioning for subarachnoid block |
| 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 Akash Gupta |
| Designation |
PG Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Dept. of Anaesthesia and Intensive Care
VMMC and Safdarjung Hospital
New Delhi
110029
South West
DELHI
110029
India |
| Phone |
8527322173 |
| Fax |
|
| Email |
akkygupta1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Panwar |
| Designation |
Professor |
| Affiliation |
Vmmc and Safdarjung Hospital |
| Address |
Dept. of Anaesthesia and Intensive care
VMMC and Safdarjung Hospital
New Delhi
110029
South West
DELHI
110029
India |
| Phone |
9013000543 |
| Fax |
|
| Email |
drmkumath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Panwar |
| Designation |
Professor |
| Affiliation |
Vmmc and Safdarjung Hospital |
| Address |
Dept. of Anaesthesia and Intensive care
VMMC and Safdarjung Hospital
New Delhi
110029
South West
DELHI
110029
India |
| Phone |
9013000543 |
| Fax |
|
| Email |
drmkumath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive care
VMMC and Safdarjung Hospital
New Delhi
110029 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Intensive Care |
| Address |
VMMC and Safdarjung Hospital
New Delhi
110029 |
| 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 Akash Gupta |
Safdarjung Hospital |
Department of Anaesthesia and Intensive Care
VMMC and Safdarjung Hospital
New Delhi
110029
South
DELHI |
8527322173
akkygupta1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Safdarjung Institutional Ethics Committee |
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
|
| Type |
Name |
Details |
| Comparator Agent |
Evaluation of use of verbal explanation on optimal positioning for subarachnoid block. |
Comparison of use of verbal explanation on optimal positioning for patients undergoing surgeries in subarachnoid block
18 months |
| Intervention |
Evaluation of use of visual aid in optimal positioning for subarachnoid block. |
Use of visual aid on optimal positioning for patients undergoing surgeries in subarachnoid block 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of age 18-65 years of either gender, American Society of Anesthesiologists grade I-II, undergoing elective surgeries under sub arachnoid block |
|
| ExclusionCriteria |
| Details |
Patient with visual impairment
Any contraindication to neuraxial anesthesia.
Body mass index (BMI) greater than 30 kg/m2. Anticipated positioning difficulties due to severe arthritis or major spinal deformities |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare time taken in achieving optimal position for subarachnoid block using visual aid with verbal explanation and only verbal explanation in adult patient.
Time taken for successful needle placement (from the start of instructions until the free flow of CSF)
|
Baseline, 4 weeks & 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts taken for a successful subarachnoid block |
Baseline, 4 weeks & 8 weeks |
| Comparison between the first-attempt success rate of subarachnoid block in both groups |
Baseline, 4 weeks & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
17/11/2025 |
| 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
|
In our study, the time taken in achieving position for subarachnoid block (from instruction until the loss of lumbar lordosis) and the time taken for successful needle placement (from the start of instructions until the free flow of CSF) along with the number of skin punctures and first attempt success rate with patient satisfaction will be noted. |