| CTRI Number |
CTRI/2026/04/107451 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
31/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A simple eye test to predict success of blood patch treatment in headache patients with intracranial hypotension |
|
Scientific Title of Study
|
Correlation between Optic Nerve Sheath Diameter and clinical improvement after lumbar Epidural Blood Patch in case of Spontaneous Intracranial Hypotension. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidagdhamay Biswas |
| Designation |
DrNB Neuroanesthesiology trainee |
| Affiliation |
Institute of Neurosciences. Kolkata |
| Address |
Department of Neuroanaesthesiology and critical care, Room no. 2, 1st Floor, Institute of Neurosciences, 185/1 AJC bose road, Kolkata- 700017 Department of Neuroanaesthesiology and critical care, Room no. 2, 1st Floor, Institute of Neurosciences, 185/1 AJC bose road, Kolkata- 700017 Kolkata WEST BENGAL 700014 India |
| Phone |
9800649292 |
| Fax |
|
| Email |
vidagdho@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Dimple Shah |
| Designation |
Senior Consultant |
| Affiliation |
INSTITUTE OF NEUROSCIENCES. KOLKATA |
| Address |
2ND FLOOR. DEPARTMENT OF NEUROANESTHESIOLOGY. INSTITUTE OF NEUROSCIENCES. KOLKATA
Kolkata WEST BENGAL 700017 India |
| Phone |
9123961462 |
| Fax |
|
| Email |
drdimple10@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Dimple Shah |
| Designation |
Senior Consultant |
| Affiliation |
INSTITUTE OF NEUROSCIENCES. KOLKATA |
| Address |
185/1 ajc bose road. 2nd floor. department of neuroanesthesiology. institute of neurosciences,kolkata Department of Neuroanaesthesiology and critical care, Room no. 2, Institute of Neurosciences, 185/1 AJC bose road, Kolkata- 700017 Kolkata WEST BENGAL 700017 India |
| Phone |
9123961462 |
| Fax |
|
| Email |
drdimple10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Neurosciences, Kolkata, 185/1 AJC Bose road, Kolkata-700017, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
Institute Of Neurosciences, KOlkata |
| Address |
185/1 AJC Bose Road, Kolkata-700017 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Vidagdhamay Biswas |
Institute of Neurosciences,Kolkata |
Department of Neuroanaesthesiology and critical care, Room no. 2, 1st Floor, Institute of Neurosciences, 185/1 AJC bose road, Kolkata- 700017 Kolkata WEST BENGAL |
9123961462
drdimple10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G89-G99||Other disorders of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EPIDURAL BLOOD PATCH(EBP) |
Lumbar EBP will be delivered by team of anaesthetists, through a midline approach under aseptic condition at the lumbar spine region (L2–L5). 20 ml of autologous blood will be taken from the patient’s arm and injected into the patient’s epidural space identified by loss of resistance technique. Ocular USG will be conducted with SonoSite Micromax (SonoSite Inc., Bothell, WA, USA) ultrasonography (USG) machine. Each patient will be examined in the supine position using a linear USG probe of 10-5 MHz frequency to get ONSD at 3 mm posterior to the ocular globe. The probe will be applied on the temporal part of the closed upper eyelid with coupling gel. For each patient, investigator will perform two measurements on each eye in transverse plane. Two investigators will perform ONSD reading. The resulting four measurements will then be averaged to yield a mean ONSD to minimise interobserver variability. Initial USG ONSD will be measured before placement of the EBP. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE 1 and 2
NOT RESPONDING TO CONSERVATIVE TREATMENT
BMI less than 24 kg/metre square
DIAGNOSED WITH SIH EITHER IN CT OR MRI |
|
| ExclusionCriteria |
| Details |
GCS less than 14
ASA Grade III/ IV
Patients with previous history of surgeries involving Lumbar area e.g.
1. Scoliosis correction surgery
2. Spinal instrumentation surgery
History of congestive heart failure/ valvular heart disease/significant coronary artery diseases / cardiac conduction block/ chronic kidney diseases/ hepatic disease/ pulmonary disease/ neuropsychiatric disorders/ coagulation abnormality
Puncture site infection
Orbital injury with ocular trauma
Known structural orbital disease
Patients with hypersensitivity to any of the local anaesthetics in use
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Headache (Measured by Numeric Pain Rating Scale)
Optic Nerve Sheath Diameter |
Pre Procedure
15 Minutes Post Procedure
6 Hours Post Procedure
12 Hours Post Procedure
24 Hours Post Procedure
48 Hours Post Procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Glasgow Coma Scale
Mean Arterial Pressure
Heart Rate
Oxygen Saturation
|
Pre Procedure
15 Minutes Post Procedure
6 Hours Post Procedure
12 Hours Post Procedure
24 Hours Post Procedure
48 Hours Post Procedure |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
15/04/2026 |
| 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="3" 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
|
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Brief Summary
|
Spontaneous intracranial hypotension (SIH) was first described in 1938. Because CSF leakage is the reason of SIH, this disease also has been named spontaneous intracranial hypovolemia. Mostly leaking sites are in the thoracic spine or at the cervicothoracic junction. Patients may have a history of trivial traumatic injury, or may have no definite history of injury. The imaging findings of SIH derived from CSF volume depletion usually show brain sagging and related complaints. SIH is characterized by orthostatic headache (OH), and DPME (diffuse pachymeningeal gadolinium enhancement) on magnetic resonance imaging (MRI), evidence of CSF leakage on conventional myelography, CT myelography or cisternography, CSF opening pressure LESS THAN 60 mmH2O in sitting position unrelated to lumbar puncture and definite trauma. OH, as defined by the International Headache Society, is a headache that occurs within 15 minutes of an upright position and is relieved within 30 minutes of recumbency. The OH characteristics may change over time, resulting in a daily chronic headache or paradoxical headache, with worsening in supine position. Various additional symptoms, like neck pain, neck stiffness, nausea, photophobia, vomiting, tinnitus, diplopia, and decreased level of consciousness have been described . Three causes, first described by Schievink et al. in 2016, that may lead to spinal CSF loss include ventral dural tear (type 1), leaking nerve root diverticulum (type 2) or a CSF-venous fistula (CVF; type 3) SIH is primarily treated conservatively. When more aggressive treatment is required i.e. initial conservative measures failed, an epidural blood patch (EBP) is the modality of choice. Historically, lumbar EBP has been used regardless of leak site because of its low risk and the ability of blood to travel many levels from the site of injection. Mokri B explained mechanisms that are involved in relieving the headache. The immediate headache-relief occurs when the blood inflow presses the dura mater and causes CSF volume replenishment. The secondary long-lasting relief is achieved by sealing of leak by blood inflow. The amount of blood injected in SIH patients has varied in different reports. Usually, 20 ml of autologous blood is used in the lumbar spine level in case of non-targeted EBPs. Performing an EBP on SIH patients has shown persistent symptomatic relief in up to 90% of the cases in previous studies. Ultrasound evaluation of the optic nerve sheath diameter (ONSD) has emerged in recent years as a useful non-invasive tool for estimating ICP or detecting intracranial hypotension and hypertension. It is a safe technique that can be conducted at the bedside, in real time, and is reproducible, relatively low cost, and does not carry the risks of radiation and CNS infections. ONSD is currently considered the best non-invasive modality for dynamic estimation of ICP . POCUS measurements have shown ONSD to be significantly correlating with ICP . ICP can be calculated using the formula ONSD: nICPONSD = 5.00 × ONSD - 13.92 mmHg . This is thus necessary in assessing patients in whom invasive ICP monitoring is either unavailable or is contraindicated or resource-poor areas where MRI or CT myelography/ cisternography is not easily available. An increase or decrease in fluid in the subarachnoid space can cause the ONSD to widen or narrow. The validity of using ultrasound measurements of the ONSD to assess intracranial pressure has been demonstrated, and this non-invasive and safe method has been used to assist in clinical diagnosis. It is hypothesized that the resolution of SIH can be predicted by ONSD. This study is thus being conducted to observe the correlation between ONSD measured non-invasively with symptom relief after EBP. |