Sphenopalatine Ganglion Blocks RCT (SPGblock)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03666663 |
Recruitment Status :
Completed
First Posted : September 12, 2018
Results First Posted : October 11, 2021
Last Update Posted : October 11, 2021
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Migraine |
Interventions |
Drug: Lidocaine Drug: Bupivacaine Drug: Ropivacaine Drug: Placebo |
Enrollment | 10 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Lidocaine | Bupivacaine | Ropivacaine | Placebo (Saline) |
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Participants will receive SPG blocks with lidocaine. Lidocaine: Nasal application using the Sphenocath device- cleared by FDA |
Participants will receive SPG blocks with bupivacaine Bupivacaine: Nasal application using the Sphenocath device- cleared by FDA |
Participants will receive SPG blocks with ropivacaine Ropivacaine: Nasal application using the Sphenocath device- cleared by FDA |
Participants will receive SPG blocks with placebo (saline) Placebo: Placebo Saline using the Sphenocath device- cleared by FDA |
Period Title: Overall Study | ||||
Started | 3 | 1 | 3 | 3 |
Completed | 3 | 1 | 1 | 1 |
Not Completed | 0 | 0 | 2 | 2 |
Arm/Group Title | Lidocaine | Bupivacaine | Ropivacaine | Placebo (Saline) | Total | |
---|---|---|---|---|---|---|
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Participants will receive SPG blocks with lidocaine. Lidocaine: Nasal application using the Sphenocath device- cleared by FDA |
Participants will receive SPG blocks with bupivacaine Bupivacaine: Nasal application using the Sphenocath device- cleared by FDA |
Participants will receive SPG blocks with ropivacaine Ropivacaine: Nasal application using the Sphenocath device- cleared by FDA |
Participants will receive SPG blocks with placebo (saline) Placebo: Placebo Saline using the Sphenocath device- cleared by FDA |
Total of all reporting groups | |
Overall Number of Baseline Participants | 3 | 1 | 3 | 3 | 10 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | 1 participants | 3 participants | 3 participants | 10 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
3 100.0%
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1 100.0%
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3 100.0%
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3 100.0%
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10 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | 1 participants | 3 participants | 3 participants | 10 participants | |
Female |
2 66.7%
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1 100.0%
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3 100.0%
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1 33.3%
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7 70.0%
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Male |
1 33.3%
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0 0.0%
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0 0.0%
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2 66.7%
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3 30.0%
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Race and Ethnicity Not Collected
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | |
0 | ||||||
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
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Name/Title: | Dr.Nina Riggins |
Organization: | UCSF |
Phone: | 7028064831 |
EMail: | Nina.Riggins7@gmail.com |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT03666663 |
Other Study ID Numbers: |
18-25736_SPG_2018.09 |
First Submitted: | September 8, 2018 |
First Posted: | September 12, 2018 |
Results First Submitted: | July 21, 2021 |
Results First Posted: | October 11, 2021 |
Last Update Posted: | October 11, 2021 |