| CTRI Number |
CTRI/2025/05/087758 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
27/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to assess various factors predicting the difficulty in performance of subarachnoid block |
|
Scientific Title of Study
|
a study evaluating the factors predicting the difficulty in performance of 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 |
Kiranpreet Kaur |
| Designation |
Professor |
| Affiliation |
PGIMS, ROHTAK |
| Address |
Department of anesthesia & critical care, PGIMS, Rohtak, Haryana
Department of anesthesia & critical care, PGIMS, ROHTAK, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9992249436 |
| Fax |
|
| Email |
kiranpreet72@rediff.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MONIKA |
| Designation |
SENIOR RESIDENT |
| Affiliation |
PGIMS, ROHTAK |
| Address |
Department of anesthesia & critical care, PGIMS, Rohtak, Haryana
Department of anesthesia & critical care, PGIMS, Rohtak, Haryan
Rohtak
HARYANA
124001
India |
| Phone |
9671436493 |
| Fax |
|
| Email |
drmonikayadav243@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MONIKA |
| Designation |
SENIOR RESIDENT |
| Affiliation |
PGIMS, ROHTAK |
| Address |
Department of anesthesia & critical care, PGIMS, Rohtak, Haryana
Department of anesthesia & critical care, PGIMS, ROHTAK , HARYANA
Rohtak
HARYANA
124001
India |
| Phone |
9671436493 |
| Fax |
|
| Email |
drmonikayadav243@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesia & critical care, PGIMS, ROHTAK |
|
|
Primary Sponsor
|
| Name |
Department of anesthesia critical care PGIMS ROHTAK |
| Address |
PGIMS, ROHTAK |
| 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 |
| MONIKA |
Department of anesthesia & critical care, PGIMS, ROHTAK |
Modular OT complex ( 3 & 4 floor), department of anesthesia & critical care, PGIMS, ROHTAK
Rohtak
HARYANA |
9671436493
drmonikayadav243@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BIOMEDICAL RESEARCH 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 |
Anesthesia residents( First year, second year and third year residents having more than 6 months of experienced in speciality) |
first , second and third year residents will perform a subarachnoid block on recruited patients planned for elective surgeries. |
| Intervention |
SUBARACHNOID BLOCK |
Patient undergoing elective surgeries will be planned under subarachnoid block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
One hundred and fifty patients of either sex aged 18-60 years belonging to American Society of Anaesthesiologists (ASA) physical status I or II scheduled for elective surgery under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients having Morbid obesity, vertebral deformities, coagulation abnormalities, and any patient who refuses to participate in the study |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The association of first puncture success and number of attempts with factors based on characteristics of the patient, the provider, the technique, and equipment. |
From starting the procedure to the adequate effect of subarachnoid block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Approximate Provider experience to administer successful block
|
Patient preparation to achieving the level of anesthesia |
| Number of attempts taken to administer successful block |
From patient preparation to the adequacy of subarachnoid block |
| Complications like, bloody tap, blood tinged CSF, & inadequate block will be noted |
complication will be noted after performance of subarachnoid block & level of anesthesia |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/06/2025 |
| 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="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
|
we are evaluating the various factors affecting the performance of subarachnoid block among first year, second year and third year residents. we will be taking a randomized group of 50 patients posted for infra-umbilical surgeries under subarachnoid block each for first, second and third year residents. Pre-anaesthetic
check-up of all the patients will be done day prior to the surgery. The detailed clinical history, of the patient will be
taken. All the patients will be subjected to complete general physical as well
as systemic examination during the preoperative visit.The patient’s gender, age, height, and weight
will be recorded, and BMI will be calculated. In addition, body type of patient; whether
normal, thin, muscular or obese will be noted. Group allocation depending
on Provider’s level of experience
All
the 150 patients will receive spinal anaesthesia from Providers of 3 different level
of experience
IFirst
year postgraduate student-
Having at least 6 months of experience
performing
SA or at least have performed 15 successful subarachnoid block
IISecond year postgraduate student- Residents with
>12 months of experience
in
academic anaesthesia training.
IIIThird year postgraduate student-Resident with > 24 months of
experience
in academic anaesthesia
training. |