Migraine
Conditions
Brief summary
Several observational studies have shown improvement in episodic migraine with the use of greater occipital nerve block as an acute therapy, and a recent placebo controlled trial did not show a decrease in frequency of episodic or chronic migraine; however, there has never been a placebo controlled trial to investigate the efficacy of GONB as an acute treatment for headache, and there has been no determination of guidelines for selection of patients who would be most likely to respond to GONB. In light of the above, the investigators propose a double-blind, placebo-controlled, randomized trial examining the use of GONB with lidocaine/bupivocaine in patients with an acute episodic migraine. The results of this trial are expected to guide more appropriate therapeutic management of these participants and the optimal use of this procedure. 50 subjects will be entered into this study. This study is being conducted at Thomas Jefferson University only.
Interventions
DRUGSaline
1ml of 1/3 saline
COMBINATION_PRODUCTlidocaine/bupivacaine
1ml of a 50% 2% lidocaine and 50% 0.5% bupivacaine
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* between the ages of 18 and 80 years old (inclusive) with a previous diagnosis fulfilling the international classification of headache disorders (ICHD3b) criteria for episodic migraine, presenting to clinic with an acute episodic migraine reported as at least a moderate pain level not lasting longer than 7 days at the time of injection.
Exclusion criteria
* subjects who have received greater occipital nerve block (GONB) in the past, subjects who in their own or the investigator's opinion are unable to describe their symptoms, subjects who have are scheduled to receive injection of onabotulinum toxin A within 72 hours, subjects who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects experiencing headache improvement at 2 hours | 2 hours | Headache intensity on 4 point pain scale from moderate or severe to mild or none |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects experiencing headache improvement at 30 minutes | 30 minutes | Headache intensity on 4 point pain scale from moderate or severe to mild or none. |
| Percentage of subjects experiencing headache improvement at 1 hour | 1 hour | Headache intensity on 4 point pain scale from moderate or severe to mild or none. |
| Percentage of subjects experiencing headache improvement at 24 hours | 24 hours | Headache intensity on 4 point pain scale from moderate or severe to mild or none. |
| Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 10 minutes | 10 minutes | Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia |
| Percentage of subjects experiencing headache improvement 10 minutes | 10 minutes | Headache intensity on 4 point pain scale from moderate or severe to mild or none. |
| Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 1 hour | 1 hour | Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia |
| Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 2 hours | 2 hours | Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia |
| Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 24 hours | 24 hours | Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia |
| Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 30 minutes | 30 minutes | Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia |
Countries
United States
Outcome results
None listed