Steroids in Occipital Nerve Block for Treatment of Headache

Headache Clinical Trial

Official title:

Treatment of Headache With Occipital Nerve Blocks: Comparison Trial of Anesthetic With or Without Dexamethasone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05732532
• Other study ID #: 22-007855
• Status: Recruiting
• Phase: Phase 4
• Start date: February 17, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 benefit to nerve blocks.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Headache
• Occipital Nerve Block

Intervention

Drug:
• 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
• Normal saline
0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves

Procedure:
• Greater/lesser occipital nerve blocks
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.

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache days 1 week following treatment	Number of self-reported days subjects experience headaches in the past week following treatment	1 week
Primary	Headache days 2 weeks following treatment	Number of self-reported days subjects experience headaches in the past weeks following treatment	2 weeks
Primary	Headache days 4 weeks following treatment	Number of self-reported days subjects experience headaches in the past weeks following treatment	4 weeks
Secondary	Headache Severity	Self-reported average severity of subjects' headaches using a scale of 0-10, with 0=no pain and 10=worst pain possible following treatment	1 week, 2 weeks, 4 weeks
Secondary	Moderate or severe headache days	Number of self-reported days subjects report headaches as being moderate or severe following treatment	1 week, 2 weeks, 4 weeks
Secondary	Acute medication use	Number of self-reported days subject had to take acute pain medication for their headaches following treatment	1 week, 2 weeks, 4 weeks
Secondary	Location of headache	Self-reported location of headache (front, back, other) following treatment	1 week, 2 weeks, 4 weeks