Clinical trial NCT02031822: Two US-guided Techniques for Greater Occipital Nerve Blocks
Official title: Evaluation of Two Ultrasound-guided Techniques for Greater Occipital Nerve Injections of Local Anesthetic and Steroid for Treatment of Primary Headaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Headache
Keywords: Primary Headache
Greater Occipital Nerve
Ultrasound
Chronic Pain
Cervicogenic
Occipital Neuralgia
Migraine
Tension type headache
Cluster headache
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Diagnosis of refractory primary headache, any type
3. Baseline NRS headache score of \> 4 refractory to conventional oral analgesic therapy (anti-inflammatory drugs, migraine prophylaxis and treatment drugs, opioids).

Exclusion Criteria:

1. Ongoing litigation issues related to the patient's pain
2. Pregnancy
3. Allergy to steroids or local anesthetics
4. Multiple serious comorbidities
5. Age \< 18 or age ≥ 80 years
6. GON injection within last 3 months at time of entry into the trial

Primary outcomes:
measure: Numerical rating score (NRS) for headaches
timeFrame: One month
Secondary outcomes:
measure: Efficacy-Related Outcomes
timeFrame: 24 hours and 3 months
measure: Performance-Related Outcomes
timeFrame: During procedure
measure: Safety-Related Outcomes
timeFrame: Immediate post-procedure and at 1 month
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital, University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Anuj Bhatia, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flamer D, Alakkad H, Soneji N, Tumber P, Peng P, Kara J, Hoydonckx Y, Bhatia A. Comparison of two ultrasound-guided techniques for greater occipital nerve injections in chronic migraine: a double-blind, randomized, controlled trial. Reg Anesth Pain Med. 2019 May;44(5):595-603. doi: 10.1136/rapm-2018-100306. Epub 2019 Mar 18.