HeadachePhase 4NCT05732532
Steroids in Occipital Nerve Block for Treatment of Headache
A Phase 4 study testing Bupivacaine, Lidocaine and Dexamethasone in people with Headache and Occipital Nerve Block, run by Mayo Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache, Occipital Nerve Block
- What is being tested?
- Bupivacaine, Lidocaine and Dexamethasone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2023to 1 Jun 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treated for headache including but not limited to occipital neuralgia, episodic migraine, chronic migraine and/or cervicogenic headache.
- Stable on preventative medication dosing for at least 1 month prior to occipital nerve block and no change in preventative medication regimen during the course of the study.
- Able to understand the requirements of the study and return for treatment.
- Able to independently provide informed consent.
Who cannot join
- Diagnosis of cluster headache according to the International Classification of Headache Disorders 3rd edition.
- Occipital or other cranial nerve block administered within 3 months prior to initiation of study.
- History of adverse reaction or contraindication to any of the study ingredients (bupivacaine, lidocaine, dexamethasone).
- Pregnancy.
- Infection or bleeding at site of injection.
- Cranial bone or cervical spine defects/prior surgeries near injection site that prohibit use of landmark-based technique.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Headache With Occipital Nerve Blocks: Comparison Trial of Anesthetic With or Without Dexamethasone
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.
Read the detailed description
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.
- Conditions
- Headache, Occipital Nerve Block
- Being tested
- Bupivacaine, Lidocaine, Dexamethasone, Normal saline, Greater/lesser occipital nerve blocks
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
LidocaineDrug
0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
DexamethasoneDrug
0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Normal salineDrug
0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocksProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bupivacaine; Drug: Lidocaine; Drug: Normal saline; Procedure: Greater/lesser occipital nerve blocks |
| 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. Receives: Drug: Bupivacaine; Drug: Lidocaine; Drug: Dexamethasone; Procedure: Greater/lesser occipital nerve blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Baseline; 4 weeks
Secondary outcomes (3)
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.
Measured: Baseline,1 week, 2 weeks, 4 weeks
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
Measured: 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
Measured: Baseline, 1 week, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start17 Feb 2023
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carrie (Beth) E. Robertson, MD, Mayo Clinic
- Investigators
- Carrie Robertson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732532
- Sponsor's protocol ID
- 22-007855
- Status last verified
- May 2026
- First submitted
- 7 Feb 2023
- Last updated
- 24 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No