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Sphenopalatine Ganglion Blocks RCT (SPGblock)

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
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
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)
Hide Arm/Group Description

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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 3 participants 3 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
1
 100.0%
3
 100.0%
3
 100.0%
10
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 3 participants 3 participants 10 participants
Female
2
  66.7%
1
 100.0%
3
 100.0%
1
  33.3%
7
  70.0%
Male
1
  33.3%
0
   0.0%
0
   0.0%
2
  66.7%
3
  30.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
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.
1.Primary Outcome
Title Number of Participants With a Reduction in Headache Days From Baseline to Month 8 of Treatment
Hide Description Reduction in headache days from baseline to month 8 of treatment as self- reported by the patients (yes/no) and as per headache diary and retrospective charts review documentation
Time Frame 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Bupivacaine Ropivacaine Placebo (Saline)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 3 1 3 3
Measure Type: Number
Unit of Measure: participants
3 1 1 0
Time Frame 1 year
Adverse Event Reporting Description follow up appointments and chart review
 
Arm/Group Title Lidocaine Bupivacaine Ropivacaine Placebo (Saline)
Hide Arm/Group Description

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

All-Cause Mortality
Lidocaine Bupivacaine Ropivacaine Placebo (Saline)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/1 (0.00%)   0/3 (0.00%)   0/3 (0.00%) 
Hide Serious Adverse Events
Lidocaine Bupivacaine Ropivacaine Placebo (Saline)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/1 (0.00%)   0/3 (0.00%)   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lidocaine Bupivacaine Ropivacaine Placebo (Saline)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/1 (0.00%)   0/3 (0.00%)   0/3 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr.Nina Riggins
Organization: UCSF
Phone: 7028064831
EMail: Nina.Riggins7@gmail.com
Publications:
Layout table for additonal information
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