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

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by Antoun Nader, Northwestern University
Sponsor:
Information provided by (Responsible Party):
Antoun Nader, Northwestern University
ClinicalTrials.gov Identifier:
NCT02655523
First received: January 12, 2016
Last updated: December 9, 2016
Last verified: December 2016
  Purpose
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 Intervention Phase
Headache Drug: Triamcinolone Drug: Dexamethasone Drug: Normal Saline Drug: Bupivacaine Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Antoun Nader, Northwestern University:

Primary Outcome Measures:
  • PROMIS (Patient Reported Outcome Measurement Information System) Pain Intensity Questionnaire [ Time Frame: 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:
  • Patients Global Impression of Change (PIGC) questionnaire [ Time Frame: 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.

  • Headache Under-Response to Treatment (HURT) questionnaire [ Time Frame: Baseline and 3 month ]
    The HURT Questionnaire consists of eight questions which the patient answers as a measure of effectiveness of intervention against headache.


Estimated Enrollment: 75
Study Start Date: December 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Kenalog
Drug: Bupivacaine
2 mL of 0.5% bupivacaine
Other Name: 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 Name: Decadron
Drug: Bupivacaine
2 mL of 0.5% bupivacaine
Other Name: 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 Name: 0.9% sodium chloride
Drug: Bupivacaine
2 mL of 0.5% bupivacaine
Other Name: Sensorcaine

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02655523

Contacts
Contact: Mark C Kendall, MD 312-695-2528 m-kendall@northwestern.edu

Locations
United States, Illinois
Northwestern University, Feingberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Mark Kendall, M.D.    312-695-2528    m-kendall@northwestern.edu   
Principal Investigator: Antoun Nader, M.D.         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Antoun Nader, MD Northwestern University Feinberg School of Medicine
  More Information

Responsible Party: Antoun Nader, Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT02655523     History of Changes
Other Study ID Numbers: STU00200460
Study First Received: January 12, 2016
Last Updated: December 9, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dexamethasone acetate
Triamcinolone hexacetonide
Dexamethasone
Triamcinolone
Triamcinolone Acetonide
BB 1101
Triamcinolone diacetate
Bupivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on September 19, 2017