Two US-guided Techniques for Greater Occipital Nerve Blocks

Primary Headache Clinical Trial

— GON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031822
• Other study ID #: 13-6804
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: May 2018

Study information

• Verified date: October 2017
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Primary Headache

Intervention

Procedure:
• US-guided Greater Occipital Nerve Injection
Medication injected around the greater occipital nerve: 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Toronto Western Hospital, University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical rating score (NRS) for headaches		One month
Secondary	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
Secondary	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
Secondary	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