Greater Occipital Nerve Block for Spontaneous Intracranial Hypotension

Spontaneous Intracranial Hypotension Clinical Trial

Official title:

Role of Greater Occipital Nerve Block in Headache From Spontaneous Intracranial Hypotension: a Prospective Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06374524
• Other study ID #: R24-03
• Status: Not yet recruiting
• Start date: August 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

SIH is a debilitating neurological disorder caused by a cerebrospinal fluid leak, 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 (1). The typical presentation is moderate-to-severe orthostatic headache and several other possible neurological symptoms, that significantly impact patients' quality of life (2).

Treatment of SIH usually starts with conservative measures, consisting of strict supine bed rest, hydration, caffeine, and simple analgesics (3). 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 (4). 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 (5). In the meantime, due to the lack of an effective and accessible alternative, patients continue to suffer.

The GONB has been reported as a simple, safe, and effective treatment to provide short-to-intermediate term relief of migraine (6), cervicogenic headache, cluster headache (7), occipital neuralgia, and more recently, post-dural puncture headaches (PDPH) (8). As the pathophysiology of intracranial hypotension caused by SIH or PDPH is very similar (9), 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.

We 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: June 1, 2026
• Est. primary completion date: February 1, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

1. Adults of > 18 years of age

2. Diagnosis of SIH, according to the International Classification of Headache Disorder (ICHD-3) classification (2)

3. Characteristics of pain:

1. Baseline pain intensity NRS > 4/10 (in upright position)

Exclusion criteria

1. 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

2. Any significant cognitive or language barrier that impedes participation

3. Patients taking opioid medications with daily Oral Morphine Equivalent (OME) of 50 mg or higher

4. Patient refusal

Related Conditions & MeSH terms

• Hypotension
• Intracranial Hypotension
• Spontaneous Intracranial Hypotension

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in headache intensity	The difference in the change in intensity of headache, as measured on an 11-point Numerical Rating Scale (NRS) (14), measured 30 minutes after the intervention, after being positioned in an upright position for 10 minutes, compared to baseline.	30 minutes post intervention