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

Primary Purpose

Primary Headache

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
US-guided Greater Occipital Nerve Injection
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Headache focused on measuring Primary Headache, Greater Occipital Nerve, Ultrasound, Chronic Pain, Cervicogenic, Occipital Neuralgia, Migraine, Tension type headache, Cluster headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mount Sinai Hospital
  • Toronto Western Hospital, University Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

US-guided Distal GON Block (Group D)

US-guided Proximal GON Block (Group P)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Numerical rating score (NRS) for headaches

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 7, 2014
Last Updated
May 29, 2018
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02031822
Brief Title
Two US-guided Techniques for Greater Occipital Nerve Blocks
Acronym
GON
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Headache
Keywords
Primary Headache, Greater Occipital Nerve, Ultrasound, Chronic Pain, Cervicogenic, Occipital Neuralgia, Migraine, Tension type headache, Cluster headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
US-guided Distal GON Block (Group D)
Arm Type
Active Comparator
Arm 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.
Arm Title
US-guided Proximal GON Block (Group P)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
US-guided Greater Occipital Nerve Injection
Intervention Description
Medication injected around the greater occipital nerve: 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg.
Primary Outcome Measure Information:
Title
Numerical rating score (NRS) for headaches
Time Frame
One month
Secondary Outcome Measure Information:
Title
Efficacy-Related Outcomes
Description
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.
Time Frame
24 hours and 3 months
Title
Performance-Related Outcomes
Description
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.
Time Frame
During procedure
Title
Safety-Related Outcomes
Description
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.
Time Frame
Immediate post-procedure and at 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anuj Bhatia, MD FRCPC
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Toronto Western Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30886069
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.
Results Reference
derived

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Two US-guided Techniques for Greater Occipital Nerve Blocks

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