Greater Occipital Nerve Block for Spontaneous Intracranial Hypotension

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spontaneous Intracranial Hypotension
• Intervention / Treatment: Procedure: greater occipital nerve block

• Study Type: Observational
• Enrollment (Estimated): 34

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with documented SIH will be recruited from the Toronto Academic Pain Medicine Institute (TAPMI) and enrolled after consent is obtained.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypotension; Intracranial Hypotension
• Other Study ID Numbers: R24-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No