Trial Outcomes & Findings for Sphenopalatine Ganglion Block for Headache After Concussion (NCT NCT04650282)
NCT ID: NCT04650282
Last Updated: 2022-09-14
Results Overview
Patients will rate their headache on a scale of 0 to 6, with 0 corresponding to "absent" and 6 corresponding to "severe."
TERMINATED
PHASE2
2 participants
48 hours pre-SPG to 48 hours after SPG block
2022-09-14
Participant Flow
Participant milestones
| Measure |
Lidocaine in SphenoCath Device
One treatment was given.
Lidocaine in SphenoCath device: Participants received 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds.
|
Saline Solution in SphenoCath Device
One treatment was given.
Saline Solution in SphenoCath device: Participants received saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sphenopalatine Ganglion Block for Headache After Concussion
Baseline characteristics by cohort
| Measure |
Lidocaine in SphenoCath Device
n=1 Participants
One treatment was given.
Lidocaine in SphenoCath device: Participants received 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds.
|
Saline Solution in SphenoCath Device
n=1 Participants
One treatment was given.
Saline Solution in SphenoCath device: Participants received saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
20 to 45 years of age
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 48 hours pre-SPG to 48 hours after SPG blockPopulation: Because only one participant was involved in each arm, showing data could violate privacy interests.
Patients will rate their headache on a scale of 0 to 6, with 0 corresponding to "absent" and 6 corresponding to "severe."
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2, 24 hours after SPG blockPopulation: Because only one participant was involved in each arm, showing data could violate privacy interests.
A rating scale of global improvement which participants use a seven-point scale ("1" = very much improved, "4" = no change, "7" very much worse). Participants will rate their change at two hours and 24 hours following the SPG block procedure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 week before SPG block, up to 1 week post SPG blockPopulation: Because only one participant was involved in each arm, showing data could violate privacy interests.
The number of headache episodes over the one week prior to the SPG block compared to one week after the procedure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 hours pre SPG to 48 hours post blockPopulation: Because only one participant was involved in each arm, showing data could violate privacy interests.
The number of headache episodes prior to the SPG block to after the procedure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 week before SPG block up to 1 week post SPG blockPopulation: Because only one participant was involved in each arm, showing data could violate privacy interests.
The number of headache episodes over the one week prior to the SPG block to one week after the procedure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 week before SPG block, up to 1 week post SPG blockPopulation: Because only one participant was involved in each arm, showing data could violate privacy interests.
The number hours with headache 1 week prior to the SPG block and for up to 1 week after the procedure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 hours pre SPG up to 48 hours post SPGPopulation: Because only one participant was involved in each arm, showing data could violate privacy interests.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 week before SPG block to 1 week post SPG blockPopulation: Because only one participant was involved in each arm, showing data could violate privacy interests.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 week before SPG block, up to 1 week post SPGPopulation: Because only one participant was involved in each arm, showing data could violate privacy interests.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 week before SPG block up to 1 week post SPGPopulation: Because only one participant was involved in each arm, showing data could violate privacy interests.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 week before SPG block to 1 week post SPG blockPopulation: Because only one participant was involved in each arm, showing data could violate privacy interests.
Patients will be asked to report the number of uses of as-needed headache medications used in the one week prior to the SPG block and after SPG block for up to one week after the procedure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 hours before SPG block to 48 hours post SPG blockPopulation: Because only one participant was involved in each arm, showing data could violate privacy interests.
Patients will be asked to report the number of uses of as-needed headache medications used in the one week prior to the SPG block and after SPG block for up to one week after the procedure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 week before SPG block up to 1 week post SPG blockPopulation: Because only one participant was involved in each arm, showing data could violate privacy interests.
Patients will be asked to report the number of uses of as-needed headache medications used in the one week prior to the SPG block and after SPG block for up to one week after the procedure.
Outcome measures
Outcome data not reported
Adverse Events
Lidocaine in SphenoCath Device
Saline Solution in SphenoCath Device
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place