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Two US-guided Techniques for Greater Occipital Nerve Blocks (GON)

University Health Network, Toronto logo

University Health Network, Toronto

Status

Completed

Conditions

Primary Headache

Treatments

Procedure: US-guided Greater Occipital Nerve Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT02031822
13-6804

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

US-guided Distal GON Block (Group D)
Active Comparator group
Description:
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.
Treatment:
Procedure: US-guided Greater Occipital Nerve Injection
US-guided Proximal GON Block (Group P)
Active Comparator group
Description:
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.
Treatment:
Procedure: US-guided Greater Occipital Nerve Injection

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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