| CTRI Number |
CTRI/2025/01/078959 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study for Assessing the Expected and Actual Pain of Back Injection in Pregnant Women Undergoing Caesarean Delivery |
|
Scientific Title of Study
|
A Cross-Sectional Study to Evaluate the Anticipated and
Experienced Pain at the Site of Spinal Needle Insertion in
Patients Undergoing Elective Lower Segment Caesarean Section |
| 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 Hari Pooja Mutukundu |
| Designation |
Postgraduate (MD Anaesthesiology) |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology SRM Medical College and Research
Centre, SRM Hospital, Potheri Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8639545634 |
| Fax |
|
| Email |
hpooja98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swetha Ramani C |
| Designation |
Associate Professor (Department of Anaesthesiology) |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Room no: 209, B-Block, 2nd Floor, Department of Anaesthesiology,
SRM Medical College and Research Institute, Kattankulathur.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884782554 |
| Fax |
|
| Email |
swethark@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swetha Ramani C |
| Designation |
Associate Professor (Department of Anaesthesiology) |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Room no: 209, B-Block, 2nd Floor, Department of Anaesthesiology,
SRM Medical College and Research Institute, Kattankulathur.
TAMIL NADU
603203
India |
| Phone |
9884782554 |
| Fax |
|
| Email |
swethark@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Tamil Nadu, 603203, India |
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital and Research Centre |
| Address |
SRM Nagar Potheri Kattankulathur 603203 |
| 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 |
| Hephzibah Solomon P |
SRM Institute of Science and Technology |
Room no:209,
B-BLOCK, 2nd floor,
Department of
anesthesiology, SRM
Medical college and
Research Institute,
Kattankulathur
Kancheepuram
TAMIL NADU |
8015326086
hepzzsolomon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Ethics Committee- Students |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant Women
ASA PS Grade 2 and 3
Elective Caesarean Section |
|
| ExclusionCriteria |
| Details |
Patient Refusal
Contraindications for spinal anaesthesia
Inability to comprehend information
Previous history of chronic lower back pain
Previous spinal anaesthesia experience
More than 2 attempts for spinal anaesthesia
Spinal conduct duration more than 20 minutes
Cutting spinal needle more than 25G size |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the anticipated and experienced pain at the site of spinal needle insertion |
The day before surgery, and after spinal needle insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the anxiety associated with pain |
Day before surgery |
| Number of attempts needed for spinal anaesthesia |
At time of giving spinal anaesthesia |
| Time taken for spinal anaesthesia |
Immediately after drug is given in spinal needle |
| To correlate the associated anxiety with the anticipated pain |
After collection of data |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/02/2025 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A total of 40 pregnant women, ASA grade II and III, scheduled for elective caesarean section will be studied prospectively. In this cross-sectional study, the anticipated and experienced pain at the site of spinal needle insertion will be evaluated. The anxiety associated with pain, number of attempts needed for successful spinal anaesthesia, time taken for spinal anaesthesia, and the correlation of associated anxiety with the anticipated pain will also be evaluated. Data collection will be done by questioning and observing the patients. |