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

June 17, 2022 updated by: Antoun Nader, Northwestern University

A Comparison of Dexamethasone and Triamcinolone in Combination With Bupivacaine for Ultrasound-guided Occipital C2 Nerve Blocks: A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University, Feingberg School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: Bupivacaine
2 mL of 0.5% bupivacaine
Other Names:
  • Sensorcaine
Drug: Dexamethasone
1 mL of 4mg of Dexamethasone
Other Names:
  • Decadron
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: Bupivacaine
2 mL of 0.5% bupivacaine
Other Names:
  • Sensorcaine
Drug: Normal Saline
1 mL of preservative free normal saline
Other Names:
  • 0.9% sodium chloride

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
2 weeks interval for up to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
2 week interval for for up to 12 weeks
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.
Baseline and 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Antoun Nader, MD, Northwestern University Feinberg School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU00200460

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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