| CTRI Number |
CTRI/2025/10/096523 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of three sitting positions-traditional,parallel leg and crossed leg for ease of spinal needle insetionin women undergoing cesarean section under spinal anaesthesia. |
|
Scientific Title of Study
|
Comparison of traditional,parallel leg and crossed leg sitting position for the ease of spinal needle placement in patients undergoing cesarean section under spinal anaesthesia - A prospective randomised comparative study |
| 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 Aiswarya Pavithran |
| Designation |
Post graduate |
| Affiliation |
Rajarajeswari Medical College And Hospital |
| Address |
Department of Anaesthesiology,Rajarajeswari Medical College And Hospital,Mysore road,Kambipura,Banglore.
Bangalore
KARNATAKA
560074
India |
| Phone |
9538762629 |
| Fax |
|
| Email |
aishwaryapavi16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manasa M |
| Designation |
Associate professor |
| Affiliation |
Rajarajeswari Medical College And Hospital |
| Address |
Associate professor Department of Anaesthesiology,2nd floor hospital building Rajarajeswari Medical College And Hospital,Mysore road,Kambipura,Banglore.
Bangalore
KARNATAKA
560074
India |
| Phone |
8971180007 |
| Fax |
|
| Email |
drmanasa29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manasa M |
| Designation |
Associate professor |
| Affiliation |
Rajarajeswari Medical College And Hospital |
| Address |
Associate professor Department of Anaesthesiology,2nd floor hospital building Rajarajeswari Medical College And Hospital,Mysore road,Kambipura,Banglore.
Bangalore
KARNATAKA
560074
India |
| Phone |
8971180007 |
| Fax |
|
| Email |
drmanasa29@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aiswarya Pavithran |
| Address |
Rajarajeswari Medical College and Hospital
MysoreRoad Kambipura Bangalore Bangalore KARNATAKA 560074 India |
| 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 |
| Aiswarya pavithran |
Rajarajeswari medical college and hospital |
2nd floor hospital
building,department of
Anaesthesiology,Rajara
jeswari medical college
and hospital 560074
Bangalore
KARNATAKA |
9538762629
aishwaryapavi16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,Rajarajeswari medical college and hospital |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade II
term parturient
Singleton pregnancy scheduled for elective lower segment cesarean section under spinal anaesthesia. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the ease of successful spinal needle placement in first attempt |
to note intra operative vitals at
0,5,10,15,30,45,60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the ease of palpation of the bony landmarks
To assess the number of needle bone contact
To assess the comfort of the patients |
Total time taken for the spinal puncture-defined as the time from the starting point of skin
puncture with the spinal needle to the free flow of cerebrospinal fluid. |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
10/11/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Aim of the study is to compare various postioning like traditional sitting position,crossed leg position and parallel leg position in patients undergoing elective cesarean section under spinal anesthesia to assess various paramerters like ease of succesful spinal needle placement in first attempt, easy palpation of the bony landmarks ,number oftimes needle comes in contact with the bone ,time taken for the free flow of csf following the spinal needle puncture and also the comfort of the patients. Intraoperatively the vitals of the patients will be monitored and postoperatively for the development of any complications like post dural puncture headache,pain,numbness or weakness |