Two US-guided Techniques for Greater Occipital Nerve Blocks

Study Overview
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Brief Summary
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Headache is one of the most common reasons for patients to access healthcare. Greater occipital nerve (GON) block with local anesthetic and steroid has been described for the management of primary headache refractory to conventional treatment. Two ultrasound (US)-guided techniques for greater occipital nerve (GON) block have been described for the management of refractory headache syndromes: a proximal technique performed at the level of the second cervical vertebra and a distal technique performed at the level of the superior nuchal line. Our airm is to compare the accuracy, efficacy and safety of these two techniques in patients with refractory headaches.

Detailed Description
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We conducted a double-blinded, randomized control trial to compare accuracy, efficacy and safety of these two techniques in patients with refractory headache syndromes. Following REB approval, 40 patients with moderate or severe refractory headaches (intensity score>4/10) will be randomized to the proximal or distal groups with a 1:1 allocation. Each patient receives an injection of 2ml of 0.5% bupivacaine with 40mg of methylprednisolone. The null hypothesis is that there is no difference in intensity scores for headache at one month after the interventions. Outcomes related to efficacy (numbness immediately after the injection, reduction in episodes of severe headache, sleep quality), performance (time taken for and discomfort during procedure), and safety (incidence of hematoma, intravascular injection) are measured after one month.

Official Title
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Evaluation of Two Ultrasound-guided Techniques for Greater Occipital Nerve Injections of Local Anesthetic and Steroid for Treatment of Primary Headaches

Conditions
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Primary Headache

Intervention / Treatment
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* Procedure: US-guided Greater Occipital Nerve Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Features suggestive of occipital neuralgia: pain that begins in the upper neck and back of the head with radiation forward toward the eye and has an aching or burning character. Diagnosis of refractory primary headache, any type Baseline NRS headache score of > 4 refractory to conventional oral analgesic therapy (anti-inflammatory drugs, migraine prophylaxis and treatment drugs, opioids). Exclusion Criteria: Ongoing litigation issues related to the patient's pain Pregnancy Allergy to steroids or local anesthetics Multiple serious comorbidities Age < 18 or age ≥ 80 years GON injection within last 3 months at time of entry into the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: US-guided Distal GON Block (Group D)<br>Needle placement for 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg will be performed under US guidance at the level of the superior nuchal line lateral to the external occipital protuberance, close to the occipital artery. | Procedure: US-guided Greater Occipital Nerve Injection<br>* Medication injected around the greater occipital nerve: 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg.<br>|
| Active Comparator: US-guided Proximal GON Block (Group P)<br>Needle placement for 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg will be performed under US guidance at the level of the bifid C2 spinous process laterally, between the inferior obliquus capitis and semispinalis capitis muscles. | Procedure: US-guided Greater Occipital Nerve Injection<br>* Medication injected around the greater occipital nerve: 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating score (NRS) for headaches |  | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy-Related Outcomes | This would include NRS for headache at 24 hrs and 3 months after the intervention, patient satisfaction with the block, Hospital Anxiety and Depression Scale at 1 month compared to baseline, SF-36 Short Form Health Survey to measure improvement in functional status compared to baseline, quality of sleep and average hours of restful sleep at night. | 24 hours and 3 months | 
| Performance-Related Outcomes | We will measure performance time from contact of US probe with skin to the end of the procedure, procedural discomfort as rated by NRS, number of needle re-adjustments and evidence of sensory block as confirmed by the loss of pin-prick sensation in the dermatomal distribution of GON, and visualization of GON. | During procedure | 
| Safety-Related Outcomes | Any immediate post intervention complications will be recorded (e.g. hematoma, vascular puncture, dizziness). Occurrence of any long-term adverse effects (e.g. infection, numbness, alopecia) will be recorded at 1 month following the intervention. | Immediate post-procedure and at 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Headache, Greater Occipital Nerve, Ultrasound, Chronic Pain, Cervicogenic, Occipital Neuralgia, Migraine, Tension type headache, Cluster headache