Greater Occipital Nerve Block for Spontaneous Intracranial Hypotension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: greater occipital nerve block.
- Who it may be relevant to
- Registry conditions: Spontaneous Intracranial Hypotension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Role of Greater Occipital Nerve Block in Headache From Spontaneous Intracranial Hypotension: a Prospective Observational Study
Overview
Spontaneous Intracranial Hypotension (SIH) is a debilitating neurological disorder caused by a cerebrospinal fluid leak (CSF), with an estimated incidence of 5 per 100,000 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, and/or 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
Interventions
- Procedure greater occipital nerve block
Patients will receive an ultrasound-guided bilateral GONB (distal approach) of 5 mLs of injectate of bupivacaine 0.25% (5 mLs) + depomedrol 40 mg in 1 mL (3 mLs to each side).
Primary outcome measures
- Change in headache intensity [Time frame: 30 minutes post intervention]
Secondary outcome measures (10)
- pain intensity [Time frame: day 1,3,7,14]
- Onset of headache [Time frame: at 30 minutes post-intervention and on the morning of day 1, 3, 7, and 14 post-intervention]
- Sitting endurance [Time frame: at 30 minutes post-intervention and on the morning of days 1, 3, 7, and 14 post-intervention (in minutes]
- SIH associated central nerve system symptoms, such hearing loss, tinnitus, tremor, balance difficulties [Time frame: at 30 minutes post-intervention and on days 1, 3, 7, and 14 post-intervention]
- Level of generalized anxiety [Time frame: at day 14 post-intervention]
- patient satisfaction [Time frame: at day 14 post-intervention]
- analgesic consumption [Time frame: daily up to day 14]
- adverse effects [Time frame: daily up to day 14]
- Level of Pain Catastrophizing [Time frame: at Day 14 post-intervention]
- Level of depression [Time frame: at Day 14 post-intervention]
Eligibility criteria
Inclusion criteria
- Adults of > 18 years of age
- Diagnosis of SIH, according to the International Classification of Headache Disorder (ICHD-3) classification (2)
- Characteristics of pain:
- Baseline pain intensity NRS > 4/10 (in upright position)
Exclusion criteria
- Contraindications to GONB: ongoing infection (systemic or located at the site of injection), intake of anticoagulants (not aspirin), allergy to injectate, contra-indication to injectate of steroids
- Any significant cognitive or language barrier that impedes participation
- Patients taking opioid medications with daily Oral Morphine Equivalent (OME) of 50 mg or higher
- Patient refusal
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Toronto Western Hospital — Toronto
Identifiers
NCT: NCT06374524 · 24-5568