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Currently there is limited evidence of benefit for the addition of steroids to occipital nerve blocks for treatment of headache, and not all steroids have been explored. The purpose of this research is to learn more about whether the addition of a specific kind of steroid (dexamethasone) provides any additional benefit to nerve blocks.
Patients who are referred by their neurology provider for occipital nerve block as treatment of headache according to current accepted standard of care will be considered for this study. Baseline data will be obtained from the patients prior to proceeding with their nerve block and their headache diagnosis will be recorded based on electronic medical record review. Patients will be randomized to one of two treatment arms, anesthetic with dexamethasone or anesthetic without dexamethasone. The injectate will be the same color and amount of solution for each trial arm. Thus, the neurology provider performing the injection remains blinded and the patient remains blinded.
Injection sites will be inspected to ensure no active bleeding, infection, cranial bone or cervical spine defects/prior surgeries that prohibit safe use of landmark-based technique. A neurologist who is experienced at performing nerve blocks will administer the injections to the bilateral greater and lesser occipital nerves using the landmark-based technique. The occipital protuberance and mastoid process are palpated, with the location of the greater occipital nerve at approximately 1/3 the distance laterally and the lesser occipital nerve at approximately 2/3 the distance laterally along the nuchal ridge for a total of 4 injection sites.
Patients will be observed for approximately 10 minutes after the procedure to monitor for any immediate adverse effects and to ensure that anesthesia in the distribution of the injected nerves was achieved. Then, they will be instructed to keep a headache diary after treatment and will be provided a written example diary. A study staff who remains blinded to the patient's trial arm (but not necessarily the neurology provider who performed the injection) will contact the patients via telephone at 1, 2 and 4 weeks to assess response to treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anesthetic without steroid group | Active Comparator | Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care will receive standard of care medication, including lidocaine and bupivacaine and normal saline. |
|
| Anesthetic with dexamethasone group | Experimental | Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care will receive standard of care medication, including lidocaine and bupivacaine and dexamethasone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Headache Days 1 Week Following Treatment | The change in the number of self-reported days subjects experienced headaches from baseline to 1 week. | Baseline; 1 week |
| Change in Headache Days 2 Weeks Following Treatment | The change in the number of self-reported days subjects experienced headaches from baseline to 2 weeks | Baseline; 2 weeks |
| Change in Headache Days 4 Weeks Following Treatment | The change in the number of self-reported days subjects experienced headaches from baseline to 4 weeks. | Baseline; 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Headache Severity | The change in the self-reported average severity of subjects' headaches using a scale of 0-10, with 0=no pain and 10=worst pain possible following treatment with higher scores indicating worse pain. | Baseline,1 week, 2 weeks, 4 weeks |
| Change in Moderate or Severe Headache Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carrie Robertson, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States |
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Two participants randomization information was lost and therefore could not be included in the participant flow, demographics, or data anlaysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anesthetic Without Steroid Group | Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and normal saline. Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves Normal saline: 0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique. |
| FG001 | Anesthetic With Dexamethasone Group | Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and dexamethasone. Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves Dexamethasone: 0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Two participants randomization information was lost and therefore could not be included in the participant flow, demographics, or data analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Anesthetic Without Steroid Group | Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and normal saline. Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves Normal saline: 0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Headache Days 1 Week Following Treatment | The change in the number of self-reported days subjects experienced headaches from baseline to 1 week. | Posted | Mean | Standard Deviation | days | Baseline; 1 week |
|
Adverse events were collected from the time of informed consent through study completion, approximately 1 month.
Adverse events were collected through examination immediately after treatment was administrated and specific questioning of the subjects at each follow up visit. Two participants randomization information was lost and therefore could not be included in the participant flow, demographics, adverse events or data analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anesthetic Without Steroid Group | Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and normal saline. Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves Normal saline: 0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tenderness/Neck Soreness at Injection Site | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carrie (Beth) Robertson, M.D. | Mayo Clinic | 507-266-4106 | robertson.carrie@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 15, 2023 | May 4, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D008012 | Lidocaine |
| D003907 | Dexamethasone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Lidocaine | Drug | 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves |
|
| Dexamethasone | Drug | 0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves |
|
| Normal saline | Drug | 0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves |
|
| Greater/lesser occipital nerve blocks | Procedure | Subjects will receive a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique. |
|
The change in the number of self-reported days subjects reported headaches as being moderate or severe following treatment |
| Baseline, 1 week, 2 weeks, 4 weeks |
| Change in Acute Medication Use | The change in the number of self-reported days subjects had to take acute pain medication for their headaches following treatment | Baseline, 1 week, 2 weeks, 4 weeks |
| BG001 | Anesthetic With Dexamethasone Group | Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and dexamethasone. Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves Dexamethasone: 0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Anesthetic With Dexamethasone Group | Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and dexamethasone. Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves Dexamethasone: 0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique. |
|
|
| Primary | Change in Headache Days 2 Weeks Following Treatment | The change in the number of self-reported days subjects experienced headaches from baseline to 2 weeks | Posted | Mean | Standard Deviation | days | Baseline; 2 weeks |
|
|
|
| Primary | Change in Headache Days 4 Weeks Following Treatment | The change in the number of self-reported days subjects experienced headaches from baseline to 4 weeks. | Posted | Mean | Standard Deviation | days | Baseline; 4 weeks |
|
|
|
| Secondary | Change in Headache Severity | The change in the self-reported average severity of subjects' headaches using a scale of 0-10, with 0=no pain and 10=worst pain possible following treatment with higher scores indicating worse pain. | Posted | Mean | Standard Deviation | score on a scale | Baseline,1 week, 2 weeks, 4 weeks |
|
|
|
| Secondary | Change in Moderate or Severe Headache Days | The change in the number of self-reported days subjects reported headaches as being moderate or severe following treatment | Posted | Mean | Standard Deviation | days | Baseline, 1 week, 2 weeks, 4 weeks |
|
|
|
| Secondary | Change in Acute Medication Use | The change in the number of self-reported days subjects had to take acute pain medication for their headaches following treatment | Posted | Mean | Standard Deviation | days | Baseline, 1 week, 2 weeks, 4 weeks |
|
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 4 |
| 58 |
| EG001 | Anesthetic With Dexamethasone Group | Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and dexamethasone. Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves Dexamethasone: 0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique. | 0 | 60 | 0 | 60 | 6 | 60 |
| Face Numbness | General disorders | Systematic Assessment |
|
| Throat Numbness | General disorders | Systematic Assessment |
|
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| D000588 |
| Amines |
| D000083 | Acetanilides |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Baseline to 4 Weeks |
|
| Baseline to 4 Weeks |
|
| Baseline to 4 Weeks |
|