| CTRI Number |
CTRI/2024/06/069388 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
23/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Can spine length and waist size predict the spread of intrathecal Bupivacaine in C-sections |
|
Scientific Title of Study
|
Can vertebral column length and abdominal girth predict the spread of intrathecal hyperbaric Bupivacaine in LSCS 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 |
Neethu Kanakaraj |
| Designation |
Junior resident |
| Affiliation |
KS Hegde Medical Academy |
| Address |
Department of anaesthesiology
PO- Nityananda Nagar
Deralakatte
Mangaluru
Department of anaesthesiology
KS Hegde Medical Academy
PO- Nityananda Nagar
Deralakatte
Mangaluru
Karnataka- 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9645160180 |
| Fax |
|
| Email |
neethukanakaraj56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ananda Bangera |
| Designation |
Professor |
| Affiliation |
KS Hegde Medical Academy |
| Address |
Dept.Of.Anaesthesiology
KS Hegde Medical Academy
PO-Nityananda Nagar
Deralakatte
Mangaluru
Karnataka- 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845278880 |
| Fax |
|
| Email |
anandabangera@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neethu Kanakaraj |
| Designation |
Junior resident |
| Affiliation |
KS Hegde Medical Academy |
| Address |
Dept.Of.Anaesthesiology
KS Hegde Medical Academy
PO-Nityananda Nagar
Deralakatte
Mangaluru
Karnataka- 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845278880 |
| Fax |
|
| Email |
neethukanakaraj56@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept.Of.Anaesthesiology and critical care
PO-Nityananda Nagar
Deralakatte, Mangaluru, 575018
KS Hegde Medical Academy |
|
|
Primary Sponsor
|
| Name |
Neethu Kanakaraj |
| Address |
Sarang, PO-Koroth Road, Azhiyur
Kozhikode, Kerala, 673309 |
| 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 |
| Dr Neethu Kanakaraj |
KS Hegde Medical Academyl |
Department of anaesthesiology
PO-Nityananda Nagar
Deralakatte, Mangaluru, 575018
Dakshina Kannada
KARNATAKA |
9645160180
neethukanakaraj56@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NITTE KS Hegde Medical Academy Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy pregnant women undergoing LSCS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Term pregnant women of age group 18Yrs-40Yrs undergoing LSCS |
|
| ExclusionCriteria |
| Details |
Significant medical morbidity including PIH
History of allergy to Bupivacaine
Failed spinal block
Obvious spinal deformities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO study the correlation between vertebral column length and abdominal girth in spread of intrathecal hyperbaric Bupivacaine in spinal anaesthesia for LSCS |
From 3 minutes after administration of spinal anaesthetic till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of vertebral column length and abdominal girth on haemodynamic parameters such as mean arterial blood pressure, heart rate, oxygen saturation |
From 3 minutes after administration of spinal anaesthetic till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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)
|
10/07/2024 |
| 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 - NO
|
|
Brief Summary
|
This prospective observational study will be conducted among pregnant women aged 18 to 40 years undergoing both elective and emergency caesarean section. The primary objective of this study is to determine whether there is any correlation between vertebral column length and abdominal girth in the spread of 0.5% [H] Bupivacaine. The secondary objective is to assess the impact of these factors on haemodynamic parameters including mean arterial blood pressure, heart rate and oxygen saturation. Vertebral column length will be measured from C7 to S1 vertebrae both in sitting and left lateral position. Abdominal girth will be measured at the level of umbilicus at the end of expiration. Sensory block level. determined by loss of cold sensation and haemodynamic parameters will be monitored at specified intervals till the end of surgery. The maximum sensory block level achieved and the time taken for the same will also be recorded. Given its observational nature, this study poses no risk to the parturients as no additional drug administration or interventions are carried out. The findings of this study will contribute in determining precise dosage requirements for spinal anaesthesia in pregnant women. Thus it potentially reduces the complications associated with this procedure such as high spinal anaesthesia. |