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NCT Number: NCT06374524

Greater Occipital Nerve Block for Spontaneous Intracranial Hypotension

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto Western Hospital

Toronto, Ontario, M3A2L8, Canada

Location status: Recruiting

Location contact

Anna Kalleitner, RN

CONTACT

[email protected]

416-603-5800 ext. 8830

Anuj Bhatia, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Greater occipital nerve block

Procedure

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 outcomes

  1. Change in headache intensity

    Time frame: 30 minutes post intervention

    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.

Secondary outcomes

  1. pain intensity

    Time frame: day 1,3,7,14

    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

  2. Onset of headache

    Time frame: at 30 minutes post-intervention and on the morning of day 1, 3, 7, and 14 post-intervention

    The time of onset or worsening of headache when positioned in a sitting position

  3. Sitting endurance

    Time frame: at 30 minutes post-intervention and on the morning of days 1, 3, 7, and 14 post-intervention (in minutes

    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))

  4. 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

    To assess the impact of SIH-associated symptoms such as tinnitus, tremor, and balance abnormalities

  5. Level of generalized anxiety

    Time frame: at day 14 post-intervention

    Emotional functioning as measured by the Generalized Anxiety Disorder-7 items (GAD-7)

  6. patient satisfaction

    Time frame: at day 14 post-intervention

    patient impression of change, as measured by the Participant Global Impression of Change (PGIC)

  7. analgesic consumption

    Time frame: daily up to day 14

    Analgesic requirement will be measured daily, by intake frequency and dose of analgesics and average daily oral morphine equivalent (OME) in mg

  8. adverse effects

    Time frame: daily up to day 14

  9. Level of Pain Catastrophizing

    Time frame: at Day 14 post-intervention

    Emotional functioning as measured by the Pain Catastrophizing Scale (PCS)

  10. Level of depression

    Time frame: at Day 14 post-intervention

    Emotional functioning as measured by the Patient Health Questionnaire for Depression-9-items (PHQ-9)

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Kalleitner, RN

CONTACT

[email protected]

416-603-5800 ext. 8830

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2024
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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