| CTRI Number |
CTRI/2024/03/064414 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to evaluate the role of optic nerve sheath diameter as a predictor of post dural puncture headache in patients undergoing elective cesarean section |
|
Scientific Title of Study
|
To evaluate the role of optic nerve sheath diameter as a predictor of post dural puncture headache in patients undergoing elective cesarean 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 |
Dr Abhijit PM |
| Designation |
Second year postgraduate resident |
| Affiliation |
Gauhati medical college and hospital |
| Address |
department of anaesthesiology and critical care, Gauhati medical college and hospital, guwahati, assam
Kamrup
ASSAM
781032
India |
| Phone |
8113983518 |
| Fax |
|
| Email |
doctorabhijitpm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Faiza Ahmed Talukdar |
| Designation |
professor and head of department |
| Affiliation |
GAUHATI MEDICAL COLLEGE AND HOSPITAL |
| Address |
department of anaesthesiology and critical care, Gauhati medical college and hospital, guwahati, assam
Kamrup
ASSAM
781032
India |
| Phone |
9864031429 |
| Fax |
|
| Email |
faizaahmedtalukdar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhijit PM |
| Designation |
Second year post graduate resident |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
department of anaesthesiology and critical care, Gauhati medical college and hospital, guwahati, assam
Kamrup
ASSAM
781032
India |
| Phone |
8113983518 |
| Fax |
|
| Email |
doctorabhijitpm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gauhati Medical College and Hospital Kamrup Metro- 781032 Assam |
|
|
Primary Sponsor
|
| Name |
Dr Abhijit PM |
| Address |
Department of anaesthesiology and critical care,Gauhati medical college and hospital, guwahati,kamrup metro,assam |
| 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 Abhijit PM |
Gauhati Medical College and Hospital |
Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital, Guwahati, Kamrup,Assam
Kamrup
ASSAM |
8113983518
doctorabhijitpm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Gauhati Medical College and Hospital, Guwahati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O894||Spinal and epidural anesthesia-induced headache during the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Age 18-40 years
2.ASA score of 2
3.Term 37-42 weeks, singleton pregnancy
4.Elective caesarean section under spinal anaesthesia
5.Informed and written consent provided
|
|
| ExclusionCriteria |
| Details |
1.Refusal of patient to take part in the study
2.Hypertensive disorders during pregnancy
3.Contraindications to spinal anaesthesia
4.Local infection of injection site
5.Coagulopathy or other bleeding disorders
6.Severe uncorrected hypovolemia
7.History of allergy to local anaesthetics used
8.Eye diseases especially history of globe rupture and history of visual disturbances
9.Conditions with changes in intracranial pressure (cerebrovascular diseases, haemorrhage, intracranial tumours)
10.Patients undergoing emergency caesarean section
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the predictive performance of optic nerve sheath diameter as a predictor of post dural puncture headache during elective cesarean section. |
before the lumbar puncture,10 minutes,24 hours,48 hours after the dural puncture and after the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the cut-off point of optic nerve sheath diameter for prediction of Post dural puncture headache |
Before dural puncture, 10 minutes,24 hours,48hours after the dural puncture, after the surgery |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
29/03/2024 |
| 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="0"
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
|
Spinal anesthesia or subarachnoid block is the most preferred choice of spinal anesthesia for cesarean section deliveries as the risk of airway management is avoided and lesser risk of neonatal drug transfer. post dural puncture headache [PDPH] is a serious and common complication occurring after spinal anesthesia. its incidence ranges from 1% to 36% and occurs mostly within 72 hours after the lumbar puncture is performed. the incidence of PDPH is attributed to CSF leakage through dural puncture site. the changes in CSF pressure are reflected in optic nerve sheath which is a sheath like structure covered by a meninges and the CSF in subarachnoid space. the authenticity of using a non invasive ultrasound guided measurement of optic nerve sheath diameter as a clinical parameter for intracranial pressure has been demonstrated. the ability to predict PDPH can be used to avoid short and long term complications by timely interventions, especially in patients with higher risk factors.
in this study we hypothesize that in patients with multiple risk factors for PDPH monitoring for ONSD might help predict the occurrence of PDPH.
|