Headache, Migraine
Conditions
Keywords
Headache, Migraine
Brief summary
The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the duration of the analgesia.
Interventions
DRUGBupivacaine
Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion
DRUGPlacebo
Normal Saline Delivered by the Tx 360 Device to the Sphenopalatine Ganglion
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* are 18 - 65 years of age * present to emergency department (ED) triage with chief complaint of crescendo-onset anterior/frontal headache (affecting frontal, temporal, orbital, maxillary, and mandible region) * have a normal neurological exams
Exclusion criteria
* are less than 18 years old or greater than 65 * have any focal neurological dysfunction signs or symptoms * have a posterior/occipital/cervicogenic source predominance of headache * are febrile (oral temperature 37.7 C or 100 F) or signs of acute or chronic sinusitis, such as congestion, has been present more than 10 days, there is a high fever, the nasal mucus is an abnormal color, or complains of face pain or headaches * have self treated with pain medication or anti-emetic 4 hours prior to arrival * have a history of peripheral vascular disease, cancer, or HIV infection * are known to be pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale | 15 minutes from dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Categorical Pain Relief | 15 minutes from dose | Categorical Pain Relief at 15 minutes. Participants were asked to categorize their pain relief at 15 minutes as No, Little, Some, A Lot or Complete. The table displays the number of participants who identified their pain relief in the categories provided. |
| Headache Free at 24 Hours | 24 hours | The percentage of patients that were headache free at 24 hours by follow-up phone conversation. |
Countries
United States
Participant flow
Recruitment details
165 Patients Identified
Pre-assignment details
93 Patients Enrolled 47 Patients Excluded 25 Patients Declined
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine Bupivacaine delivered by the Tx 360 device to the sphenopalatine ganglion bilaterally | 41 |
| Normal Saline Normal Saline delivered by the Tx 360 device to the sphenopalatine ganglion bilaterally | 46 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 6 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Normal Saline | Total | Bupivacaine |
|---|---|---|---|
| Age, Continuous | 41 years | 39 years | 33 years |
| Median Baseline Headache Score | 79 units on a scale | 79 units on a scale | 80 units on a scale |
| Median Baseline Nausea Score | 0 units on a scale | 20 units on a scale | 29 units on a scale |
| Sex: Female, Male Female | 33 Participants | 64 Participants | 31 Participants |
| Sex: Female, Male Male | 13 Participants | 23 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 41 | 3 / 46 |
| serious Total, serious adverse events | 0 / 41 | 0 / 46 |
Outcome results
Primary
Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale
Time frame: 15 minutes from dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bupivacaine | Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale | 48.8 percentage of participants |
| Normal Saline | Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale | 41.3 percentage of participants |
95% CI: [-13, 27.1]
Secondary
Categorical Pain Relief
Categorical Pain Relief at 15 minutes. Participants were asked to categorize their pain relief at 15 minutes as No, Little, Some, A Lot or Complete. The table displays the number of participants who identified their pain relief in the categories provided.
Time frame: 15 minutes from dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bupivacaine | Categorical Pain Relief | A Lot of Pain Relief | 11 participants |
| Bupivacaine | Categorical Pain Relief | A Little Pain Relief | 6 participants |
| Bupivacaine | Categorical Pain Relief | Some Pain Relief | 3 participants |
| Bupivacaine | Categorical Pain Relief | Complete Pain Relief | 8 participants |
| Bupivacaine | Categorical Pain Relief | No Pain Relief | 13 participants |
| Normal Saline | Categorical Pain Relief | Complete Pain Relief | 6 participants |
| Normal Saline | Categorical Pain Relief | Some Pain Relief | 8 participants |
| Normal Saline | Categorical Pain Relief | A Lot of Pain Relief | 10 participants |
| Normal Saline | Categorical Pain Relief | No Pain Relief | 13 participants |
| Normal Saline | Categorical Pain Relief | A Little Pain Relief | 9 participants |
Secondary
Headache Free at 24 Hours
The percentage of patients that were headache free at 24 hours by follow-up phone conversation.
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bupivacaine | Headache Free at 24 Hours | 72.2 percentage of participants |
| Normal Saline | Headache Free at 24 Hours | 47.5 percentage of participants |
95% CI: [2.6, 43.6]