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A Comparison of Dexamethasone and Triamcinolone for Ultrasound-guided Occipital C2 Nerve Blocks

Sponsor
Northwestern University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02655523
Collaborator
(none)
0
Enrollment
1
Location
3
Arms
78
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Greater occipital nerve (GON) injection is a commonly performed diagnostic and therapeutic procedure in headache patients. GON blocks have been shown to be effective in the treatment of a variety of headaches including occipital neuralgia, migraine, vascular headache, cluster headache, cervicogenic headache, and post-concussive headache. Local anesthetic and steroids have been successfully used for diagnostic and or therapeutic nerve pain such as lumbar radicultis with great success. Dexamethasone is a water soluble steroid, when combined with local anesthetic; it may increase the analgesia of block duration relative to its pharmacokinetics. When compared to dexamethasone, triamcinolone, a particulate steroid has a slower onset time but may provide anti-inflammatory effects up to several weeks. Investigators want to investigate to see if there exists a difference in reported pain intensity using the particulate anti-inflammatory corticosteroid (triamcinolone with bupivacaine) which may provide a greater reduction in reported pain intensity relief may allow the patient to undergo fewer interventional procedures.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Greater occipital nerve (GON) injection is a commonly performed diagnostic and therapeutic procedure in headache patients. GON blocks have been shown to be effective in the treatment of a variety of headaches including occipital neuralgia, migraine, vascular headache, cluster headache, cervicogenic headache, and post-concussive headache.The GON provides sensory innervation to the posterior scalp to the vertex of the skull and is known to communicate with the third occipital nerve and lesser occipital nerve during its ascent at the occiput.The use of ultrasound guidance to assist with needle placement is becoming increasingly popular due to real-time visualization of soft tissue and surrounding vasculature as well as the appearance of bony structures. This imaging tool allows for fine adjustment of the needle tip and direct observation of the injectate thereby confirming local anesthetic spread at the targeted area. Local anesthetic and steroids have been successfully used for diagnostic and or therapeutic nerve pain such as lumbar radicultis with great success. Dexamethasone is a water soluble steroid, when combined with local anesthetic; it may increase the analgesia of block duration relative to its pharmacokinetics. When compared to dexamethasone, triamcinolone, a particulate steroid has a slower onset time but may provide anti-inflammatory effects up to several weeks. Investigators want to investigate to see if there exists a difference in reported pain intensity using the particulate anti-inflammatory corticosteroid (triamcinolone with bupivacaine) which may provide a greater reduction in reported pain intensity relief may allow the patient to undergo fewer interventional procedures.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Comparison of Dexamethasone and Triamcinolone in Combination With Bupivacaine for Ultrasound-guided Occipital C2 Nerve Blocks: A Randomized Controlled Trial
Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Jun 1, 2022
Actual Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Bupivacaine+Triamcinolone

An ultrasound-guided C2 nerve block with 2 mL of 0.5% bupivacaine plus 1 mL 40 mg of triamcinolone.

Drug: Triamcinolone
1 mL of 40 mg of Triamcinolone
Other Names:
  • Kenalog

    • Drug: Bupivacaine
    2 mL of 0.5% bupivacaine
    Other Names:
  • Sensorcaine

    		•
    Active Comparator: Bupivacaine+Dexamethasone

    An ultrasound-guided C2 nerve block with 2 mL of 0.5% bupivacaine plus 1 mL 4 mg of dexamethasone.

    Drug: Dexamethasone
    1 mL of 4mg of Dexamethasone
    Other Names:
  • Decadron

    • Drug: Bupivacaine
    2 mL of 0.5% bupivacaine
    Other Names:
  • Sensorcaine

    		•
    Placebo Comparator: Bupivacaine+Saline

    An ultrasound-guided C2 nerve block with 2 mL of 0.5% bupivacaine plus 1 mL of preservative free normal saline.

    Drug: Normal Saline
    1 mL of preservative free normal saline
    Other Names:
  • 0.9% sodium chloride

    • Drug: Bupivacaine
    2 mL of 0.5% bupivacaine
    Other Names:
  • Sensorcaine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PROMIS (Patient Reported Outcome Measurement Information System) Pain Intensity Questionnaire [2 weeks interval for up to 12 weeks]

      Area under the PROMIS Pain Intensity Questionnaire T-score versus time profile for the 12 week study period

    Secondary Outcome Measures

    1. Patients Global Impression of Change (PIGC) questionnaire [2 week interval for for up to 12 weeks]

      The Patient Global Impression of Change (PGIC) is a 7-point scale depicting a patient's rating of overall improvement.

    2. Headache Under-Response to Treatment (HURT) questionnaire [Baseline and 3 month]

      The HURT Questionnaire consists of eight questions which the patient answers as a measure of effectiveness of intervention against headache.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • All patients, ≥ 18 years of age and under 75 years of age, presenting to the Northwestern Pain Center with occipital headaches who are scheduled to receive a ultrasound-guided occipital nerve block will be eligible for the study.

    • Extracranial tenderness or Tinel's sign over the occipital nerve

    • Poor response to other medical treatments (narcotics, physical therapy)

    • Paroxysmal stabbing pain, with or without persistent aching between paroxysms, in the distribution(s) of the greater, lesser and/or third occipital nerves

    • Visual Analog Scale (VAS) score of at least 4 at recent headache occurrence.

    Exclusion Criteria:

    • Abnormal cranial anatomy

    • use of anticoagulants

    • local infection

    • refusal of or lack of consent

    • pregnant patients

    • systemic steroid in the last three months, steroid injection of any type in the last three months

    • inability to read

    • untreated/inadequately treated psychiatric disorders

    • cannot comprehend or complete the questionnaires

    • known allergies to local or steroids

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern University, Feingberg School of Medicine Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University

    Investigators

    • Principal Investigator: Antoun Nader, MD, Northwestern University Feinberg School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Antoun Nader, Professor of Anesthesiology, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT02655523
    Other Study ID Numbers:
    • STU00200460
    First Posted:
    Jan 14, 2016
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Headache
    Dexamethasone
    Triamcinolone
    Bupivacaine

    Study Results

    No Results Posted as of Jun 23, 2022