| CTRI Number |
CTRI/2024/05/068103 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the success of spinal needle placement in two different sitting positions in pregnant women undergoing spinal anaesthesia for cesarean section. |
|
Scientific Title of Study
|
Comparison of spinal needle placement success in cross leg sitting position and traditional sitting position in parturients undergoing cesarean delivery under 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 |
DrDeepak Sharma |
| Designation |
Post graduate resident |
| Affiliation |
Department of Anaesthesia,Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Anaesthesiology and Intensive Care, Ground floor, main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital ,Ansari Nagar, New Delhi
South West
DELHI
110029
India |
| Phone |
9810099340 |
| Fax |
|
| Email |
deepaksharma861994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrParul Mullick |
| Designation |
Professor, anaesthesia |
| Affiliation |
Department of Anaesthesia,Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive Care, Ground floor, main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital Ansari, Nagar ,New Delhi
South West
DELHI
110029
India |
| Phone |
9810606262 |
| Fax |
|
| Email |
drparulmullick@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrParul Mullick |
| Designation |
Professor, anaesthesia |
| Affiliation |
Department of Anaesthesia,Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of anaesthesiology and intensive care, Ground floor, main OT building, Vmmc and Safdarjung hospital Ansari Nagar ,New Delhi
South West
DELHI
110029
India |
| Phone |
9810606262 |
| Fax |
|
| Email |
drparulmullick@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar West, New Delhi, Delhi 110029
Phone: 011 2616 5060 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Anaesthesiology and Intensive Care, Ground floor, main OT building, Vardhman Mahavir Medical College and Safdarjung hospital ,Ansari Nagar West, New Delhi, Delhi 110029
Phone: 011 2616 5060 |
| 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 Deepak Sharma |
Vmmc and Safdarjung hospital |
Department of anaesthesiology and intensive care, Ground floor, main OT building, Vmmc and Safdarjung hospital Ansari Nagar ,New Delhi
South West
DELHI |
9810099340
deepaksharma861994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee vmmc and sjh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, (2) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
needle placement in two different positions under spinal anaesthesia |
success of needle placement in two different positions: crossed leg sitting (C) and traditional sitting (T) with ease of landmark palpation and number of attempts will be compared during spinal anaesthesia in pregnant woman undergoing caesarean section Duration 2-5 mins |
| Intervention |
spinal needle placement in two different sitting positions |
needle placement in crossed leg sitting (Group C) and traditional sitting(Group T) positions in pregnant female undergoing caesarean section and ease of success of needle placement will be observed at the time of needle insertion duration 2-5 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Term parturient with singleton pregnancy in the age group of 18 to 45 years belonging to American society of anaesthesiologist physical status class II undergoing elective caesarean delivery under spinal anaesthesia. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study will be noting the comparison of needle placement success between two different sitting position under spinal anaesthesia undergoing caesarean section. |
time at needle placement during spinal anaesthesia 5 minutes to 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcome of the study will be recording the following :
1. Ease of landmark palpation
2. The number of attempts |
time at needle placement in two different position 5minutes to 10 minutes |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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 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
|
To compare spinal needle placement success in crossed leg sitting position and traditional sitting position in parturients undergoing caesarean delivery under spinal anaesthesia. All the patients belonging to inclusion criteria will be divided in two groups by block randomisation,and success of spinal needle placement will be compared in crossed leg sitting and traditional setting position.Ease of landmark palpitation and the number of attempts will also be compared. |