Greater Occipital Nerve Block for Spontaneous Intracranial Hypotension

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spontaneous Intracranial Hypotension
• Intervention / Treatment: Procedure: greater occipital nerve block

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 Type: Observational
• Enrollment (Estimated): 34

Contacts and Locations

• Study Contact: Name: Anna Kalleitner, RN; Phone Number: 8830 416-603-5800; Email: Anna.Kalleitner@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M3A2L8
      • Recruiting
      • Toronto Western Hospital
      • Principal Investigator: Anuj Bhatia, MD, PhD
      • Contact: Anna Kalleitner, RN; Phone Number: 8830 416-603-5800; Email: Anna.Kalleitner@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with documented SIH will be recruited from the Toronto Western Hospital Intracranial Hypotension Clinic 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), measured 30 minutes after the intervention, after being positioned in an upright position for 10 minutes, compared to baseline.	30 minutes post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	The difference in the change in intensity of headache, as measured on an 11-point Numerical Rating Scale (NRS) where 0 means no pain and 10 worst pain imaginable	day 1,3,7,14
Onset of headache	The time of onset or worsening of headache when positioned in a sitting position	at 30 minutes post-intervention and on the morning of day 1, 3, 7, and 14 post-intervention
Sitting endurance	The duration of tolerance in an upright position (i.e. how long the patient can stay in an upright position until the headache becomes unbearable and urges the patient to lie down))	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	To assess the impact of SIH-associated symptoms such as tinnitus, tremor, and balance abnormalities	at 30 minutes post-intervention and on days 1, 3, 7, and 14 post-intervention
Level of generalized anxiety	Emotional functioning as measured by the Generalized Anxiety Disorder-7 items (GAD-7)	at day 14 post-intervention
patient satisfaction	patient impression of change, as measured by the Participant Global Impression of Change (PGIC)	at day 14 post-intervention
analgesic consumption	Analgesic requirement will be measured daily, by intake frequency and dose of analgesics and average daily oral morphine equivalent (OME) in mg	daily up to day 14
adverse effects		daily up to day 14
Level of Pain Catastrophizing	Emotional functioning as measured by the Pain Catastrophizing Scale (PCS)	at Day 14 post-intervention
Level of depression	Emotional functioning as measured by the Patient Health Questionnaire for Depression-9-items (PHQ-9)	at Day 14 post-intervention

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

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 (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypotension
• Other Study ID Numbers: 24-5568

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