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Steroids in Occipital Nerve Block for Treatment of Headache

Primary Purpose

Headache, Occipital Nerve Block

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Lidocaine
Dexamethasone
Normal saline
Greater/lesser occipital nerve blocks
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache

Eligibility Criteria

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

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.

Sites / Locations

  • Mayo Clinic MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Anesthetic without steroid group

Anesthetic with dexamethasone group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Headache days 1 week following treatment
Number of self-reported days subjects experience headaches in the past week following treatment
Headache days 2 weeks following treatment
Number of self-reported days subjects experience headaches in the past weeks following treatment
Headache days 4 weeks following treatment
Number of self-reported days subjects experience headaches in the past weeks following treatment

Secondary Outcome Measures

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
Moderate or severe headache days
Number of self-reported days subjects report headaches as being moderate or severe following treatment
Acute medication use
Number of self-reported days subject had to take acute pain medication for their headaches following treatment
Location of headache
Self-reported location of headache (front, back, other) following treatment

Full Information

First Posted
February 7, 2023
Last Updated
March 7, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05732532
Brief Title
Steroids in Occipital Nerve Block for Treatment of Headache
Official Title
Treatment of Headache With Occipital Nerve Blocks: Comparison Trial of Anesthetic With or Without Dexamethasone
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anesthetic without steroid group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Anesthetic with dexamethasone group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves
Intervention Type
Procedure
Intervention Name(s)
Greater/lesser occipital nerve blocks
Intervention Description
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.
Primary Outcome Measure Information:
Title
Headache days 1 week following treatment
Description
Number of self-reported days subjects experience headaches in the past week following treatment
Time Frame
1 week
Title
Headache days 2 weeks following treatment
Description
Number of self-reported days subjects experience headaches in the past weeks following treatment
Time Frame
2 weeks
Title
Headache days 4 weeks following treatment
Description
Number of self-reported days subjects experience headaches in the past weeks following treatment
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Headache Severity
Description
Self-reported average severity of subjects' headaches using a scale of 0-10, with 0=no pain and 10=worst pain possible following treatment
Time Frame
1 week, 2 weeks, 4 weeks
Title
Moderate or severe headache days
Description
Number of self-reported days subjects report headaches as being moderate or severe following treatment
Time Frame
1 week, 2 weeks, 4 weeks
Title
Acute medication use
Description
Number of self-reported days subject had to take acute pain medication for their headaches following treatment
Time Frame
1 week, 2 weeks, 4 weeks
Title
Location of headache
Description
Self-reported location of headache (front, back, other) following treatment
Time Frame
1 week, 2 weeks, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carrie Robertson, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie Robertson, MD
Phone
507-266-3544
Email
robertson.carrie@mayo.edu
First Name & Middle Initial & Last Name & Degree
Stephanie Steel, MD
Email
Steel.stephanie@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Steroids in Occipital Nerve Block for Treatment of Headache

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