| CTRI Number |
CTRI/2024/02/062990 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
18/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Relationship between abdominal circumference, length of vertebral column and shoulder-hip width ratio with sensory blockade achieved by spinal anaesthesia in pregnant women undergoing caesarean section |
|
Scientific Title of Study
|
Study of correlation of anthropometric measurements and spread of spinal anaesthesia in parturiants undergoing caesarean section – A Prospective Observational 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 |
Fayaz Sultan |
| Designation |
Postgraduate |
| Affiliation |
D Y Patil University School Of Medicine |
| Address |
D 2 101 , Nilgiri Gardens , near Ekta Vihar, Sector 26 CBD Belapur
Navi Mumbai
Maharashtra
Mumbai
MAHARASHTRA
400614
India |
| Phone |
08075371772 |
| Fax |
|
| Email |
fayazms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rochana Bakshi |
| Designation |
Professor |
| Affiliation |
D Y Patil University School Of Medicine |
| Address |
DY Patil Deemed to be University Sector 7, Nerul, Navi Mumbai: 400706
Mumbai
MAHARASHTRA
400706
India |
| Phone |
8129107707 |
| Fax |
|
| Email |
drrochana@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Fayaz Sultan |
| Designation |
Postgraduate |
| Affiliation |
D Y Patil University School Of Medicine |
| Address |
D 2 101 Nilgiri Gardens , near Ekta Vihar , Sector 26 CBD Belapur Navi Mumbai
Mumbai
MAHARASHTRA
400614
India |
| Phone |
08075371772 |
| Fax |
|
| Email |
fayazms@gmail.com |
|
|
Source of Monetary or Material Support
|
| D Y Patil University School Of Medicine
11, Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra 400706 |
|
|
Primary Sponsor
|
| Name |
D Y Patil University School Of Medicine |
| Address |
DY Patil Deemed to be University Sector 7, Nerul, Navi Mumbai: 400706 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrFayaz Sultan |
D Y Patil University School Of Medicine |
A Block ,Department of Anaesthesia
Ayyappa Temple Rd
Dr D Y Patil Vidyanagar
Sector 7
Nerul
Navi Mumbai
Mumbai
MAHARASHTRA |
8075371772
fayazms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health research (IECBH) of Dr D Y Patil Medical College & Hospital |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.All patients giving consent
2.American Society of Anesthesiology physical status Class I or II
3.All term parturiants aged 20-40 years, and who were scheduled for elective C/S under spinal anesthesia
|
|
| ExclusionCriteria |
| Details |
1.All patients giving consent
2. American Society of Anesthesiology physical status Class I or II,
3.All term parturiants aged 20-40 years, and who were scheduled for elective C/S under spinal anesthesia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of abdominal circumference - measured at the level of umbilicus , vertebral length - measured from C7 vertebra to the sacral cornu, hip/shoulder width on sensory level of spinal anesthesia |
at the time of spinal anesthesia and every 2 minutes till the first 20minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypotension and bradycardia during cesarean section caused due to the effect of spinal anesthesia |
at the time of spinal anesthesia and every 2 minutes till 20minutes after blockade |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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)
|
26/02/2024 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [fayazms@gmail.com].
- For how long will this data be available start date provided 11-02-2024 and end date provided 11-03-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Spinal anesthesia is widely used in parturients for
cesarean section.Plain bupivacaine is often used for spinal anesthesia.
However, the intrathecal spread of plain bupivacaine is highly unpredictable.Patient characteristics such as height, weight, and body mass index are
frequently used to predict spinal anesthesia spread, but the results have been
unsatisfactory.Certain
anthropometric measurements that are practically
obtainable may explain the variability in the spread of spinal anesthesia to some extent.These can be useful to clinicians for quick assessment of
the spread of sensory level of
spinal anesthesia in individual patients to avoid the risk of high block and also an inadequate
level of block.
All of the term
parturients will be kept nil per oral for 8 h before the cesarean section.Parturient will be
placed on a horizontal operating table in the supine position, and during the
end of expiration, the abdominal girth will be measured at the level of the
umbilicus. While the parturient is sitting on the operating table with a
straightened back ,VCL will be measured
from the middle of the C7 vertebra to the sacral hiatus and hip‑width is measured between the two iliac
crests, shoulder‑width is measured between two acromion processes.A total of 2mL of
0.5% plain bupivacaine is injected intrathecally over a period of 10 seconds
when free flow of CSF is obtained. After the spinal injection, the patients will
be immediately returned to the supine
position. The spinal spread will
be assessed in midclavicular line every
2 minutes using a 23-gauge needle for loss of pinprick sensation , continued
till there will be no further increase
in three consecutive observations. Time to achieve the maximum sensory level will
be defined as the time between the intrathecal injection and loss of pinprick sensation
to that level. Correlation and linear regression analysis will
be used to analyse whether any relation exists between the highest level of
sensory blockade achieved and the parturients’ VCL, Shoulder/hip width and
abdominal circumference. |