Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374524
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-04-15
Brief Title:
Greater Occipital Nerve Block for Spontaneous Intracranial Hypotension
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Role of Greater Occipital Nerve Block in Headache From Spontaneous Intracranial Hypotension a Prospective Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Spontaneous Intracranial Hypotension SIH is a debilitating neurological disorder caused by a cerebrospinal fluid leak CSF with an estimated incidence of 5 per 100000 persons per year of which mostly women between the ages of 35 years and 55 years The typical presentation is moderate-to-severe orthostatic headache and several other possible neurological symptoms that significantly impact patients quality of life
Treatment of SIH usually starts with conservative measures consisting of strict supine bed rest hydration caffeine and simple analgesics The vast majority of patients will require invasive treatments for their CSF leak such as epidural blood patches fibrin glue patches endovascular coiling andor surgical repair These specialized treatments are only offered in tertiary care centers and require specialized personnel and resources which implicates a certain waiting time for the patients before permanent treatment is offered In the meantime due to the lack of an effective and accessible alternative patients continue to suffer
The greater occipital nerve block GONB has been reported as a simple safe and effective treatment to provide short-to-intermediate term relief of migraine cervicogenic headache cluster headache occipital neuralgia and more recently post-dural puncture headaches PDPH As the pathophysiology of intracranial hypotension caused by SIH or PDPH is very similar it is stipulated that the effect of GONB will be similar for SIH patients However to date no studies exploring the efficacy of GONB for SIH have been performed
The investigators propose to do a prospective observational study to explore the outcome of GONB for SIH GONB can serve as a bridge therapy to control the debilitating headache of SIH while patients are awaiting permanent SIH treatment Moreover GONB can be performed by physicians of different specialties including neurology which makes it an accessible treatment for all patients Lastly by offering better symptom control this intervention could potentially restore patients ability to work and reduce healthcare costs
Treatment of SIH usually starts with conservative measures consisting of strict supine bed rest hydration caffeine and simple analgesics The vast majority of patients will require invasive treatments for their CSF leak such as epidural blood patches fibrin glue patches endovascular coiling andor surgical repair These specialized treatments are only offered in tertiary care centers and require specialized personnel and resources which implicates a certain waiting time for the patients before permanent treatment is offered In the meantime due to the lack of an effective and accessible alternative patients continue to suffer
The greater occipital nerve block GONB has been reported as a simple safe and effective treatment to provide short-to-intermediate term relief of migraine cervicogenic headache cluster headache occipital neuralgia and more recently post-dural puncture headaches PDPH As the pathophysiology of intracranial hypotension caused by SIH or PDPH is very similar it is stipulated that the effect of GONB will be similar for SIH patients However to date no studies exploring the efficacy of GONB for SIH have been performed
The investigators propose to do a prospective observational study to explore the outcome of GONB for SIH GONB can serve as a bridge therapy to control the debilitating headache of SIH while patients are awaiting permanent SIH treatment Moreover GONB can be performed by physicians of different specialties including neurology which makes it an accessible treatment for all patients Lastly by offering better symptom control this intervention could potentially restore patients ability to work and reduce healthcare costs
Detailed Description:
This a prospective observational study on 34 patients with SIH recruited from the Toronto Western Hospital Intracranial Hypotension Clinic Patients will receive an ultrasound-guided bilateral GONB of 5 mls of injectate of mix of local anesthetic with steroid There is no comparator Primary outcome is the change in intensity of headache at 30 minutes post-intervention Secondary outcomes are change in intensity up to day 14 post-intervention onset of headache sitting endurance change in SIH-associated central nervous system CNS symptoms emotional functioning patient satisfaction analgesic consumption and side-effect up to 14 days post-intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None