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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Headache
• Intervention / Treatment: Procedure: US-guided Greater Occipital Nerve Injection

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital, University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: US-guided Distal GON Block (Group D); 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; Medication injected around the greater occipital nerve: 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg.
ACTIVE_COMPARATOR: US-guided Proximal GON Block (Group P); 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; Medication injected around the greater occipital nerve: 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Anuj Bhatia, MD FRCPC, University Health Network, Toronto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ACTUAL): September 1, 2017
• Study Completion (ACTUAL): May 1, 2018

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 7, 2014
• First Posted (ESTIMATE): January 9, 2014

Study Record Updates

• Last Update Posted (ACTUAL): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Ultrasound; Chronic Pain; Migraine; Cluster headache; Tension type headache; Cervicogenic; Primary Headache; Greater Occipital Nerve; Occipital Neuralgia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: 13-6804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO