Trial record 4 of 4 for:    Occipital Neuralgia

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

This study is not yet open for participant recruitment.
Verified January 2014 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT02031822
First received: January 7, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Refractory Primary Headache
Procedure: US-guided Greater Occipital Nerve Injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of Two Ultrasound-guided Techniques for Greater Occipital Nerve Injections of Local Anesthetic and Steroid for Treatment of Primary Headaches

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Numerical rating score (NRS) for headaches [ Time Frame: One month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy-Related Outcomes [ Time Frame: 24 hours and 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: During procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: Immediate post-procedure and at 1 month ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 40
Study Start Date: January 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: US-guided Distal GON Block (Group D)
Needle placement 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 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02031822

Contacts
Contact: Anuj Bhatia, MD FRCA FRCPC FIPP FFPMRCA (416) 603-5118 anuj.bhatia@uhn.ca

Locations
Canada, Ontario
Toronto Western Hospital, University Health Network Not yet recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Anuj Bhatia, MD FRCA FRCPC FIPP FFPMRCA    (416) 603-5118    anuj.bhatia@uhn.ca   
Principal Investigator: Anuj Bhatia, MD FRCA FRCPC FIPP FFPMRCA         
Sub-Investigator: Husni Alakkad, MBBS, FRCPC         
Sub-Investigator: Philip Peng, MBBS, FRCPC         
Mount Sinai Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Anuj Bhatia, MBBS, FRCPC    (416) 603-5118    anuj.bhatia@uhn.ca   
Principal Investigator: Anuj Bhatia, MD FRCA FRCPC FIPP FFPMRCA         
Sub-Investigator: Allan Gordon, MD         
Sub-Investigator: Philip Peng, MBBS, FRCPC         
Sub-Investigator: Husni Alakkad, MBBS, FRCPC         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Anuj Bhatia, MD FRCA FRCPC FIPP FFPMRCA University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02031822     History of Changes
Other Study ID Numbers: 13-6804
Study First Received: January 7, 2014
Last Updated: January 7, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University Health Network, Toronto:
Primary Headache
Greater Occipital Nerve
Ultrasound
Chronic Pain
Cervicogenic
Occipital Neuralgia

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014