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

Primary Purpose

Headache

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Triamcinolone
Dexamethasone
Normal Saline
Bupivacaine
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University, Feingberg School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Bupivacaine+Triamcinolone

Bupivacaine+Dexamethasone

Bupivacaine+Saline

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

PROMIS (Patient Reported Outcome Measurement Information System) Pain Intensity Questionnaire
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
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
The HURT Questionnaire consists of eight questions which the patient answers as a measure of effectiveness of intervention against headache.

Full Information

First Posted
January 12, 2016
Last Updated
June 17, 2022
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT02655523
Brief Title
A Comparison of Dexamethasone and Triamcinolone for Ultrasound-guided Occipital C2 Nerve Blocks
Official Title
A Comparison of Dexamethasone and Triamcinolone in Combination With Bupivacaine for Ultrasound-guided Occipital C2 Nerve Blocks: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
lack of recruitment
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 2022 (Actual)
Study Completion Date
June 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine+Triamcinolone
Arm Type
Active Comparator
Arm Description
An ultrasound-guided C2 nerve block with 2 mL of 0.5% bupivacaine plus 1 mL 40 mg of triamcinolone.
Arm Title
Bupivacaine+Dexamethasone
Arm Type
Active Comparator
Arm Description
An ultrasound-guided C2 nerve block with 2 mL of 0.5% bupivacaine plus 1 mL 4 mg of dexamethasone.
Arm Title
Bupivacaine+Saline
Arm Type
Placebo Comparator
Arm Description
An ultrasound-guided C2 nerve block with 2 mL of 0.5% bupivacaine plus 1 mL of preservative free normal saline.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Other Intervention Name(s)
Kenalog
Intervention Description
1 mL of 40 mg of Triamcinolone
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
1 mL of 4mg of Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
0.9% sodium chloride
Intervention Description
1 mL of preservative free normal saline
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Sensorcaine
Intervention Description
2 mL of 0.5% bupivacaine
Primary Outcome Measure Information:
Title
PROMIS (Patient Reported Outcome Measurement Information System) Pain Intensity Questionnaire
Description
Area under the PROMIS Pain Intensity Questionnaire T-score versus time profile for the 12 week study period
Time Frame
2 weeks interval for up to 12 weeks
Secondary Outcome Measure Information:
Title
Patients Global Impression of Change (PIGC) questionnaire
Description
The Patient Global Impression of Change (PGIC) is a 7-point scale depicting a patient's rating of overall improvement.
Time Frame
2 week interval for for up to 12 weeks
Title
Headache Under-Response to Treatment (HURT) questionnaire
Description
The HURT Questionnaire consists of eight questions which the patient answers as a measure of effectiveness of intervention against headache.
Time Frame
Baseline and 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoun Nader, MD
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University, Feingberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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