Sphenopalatine Ganglion Blocks RCT (SPGblock)

• 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: University of California, San Francisco
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Lidocaine	Bupivacaine	Ropivacaine	Placebo (Saline)
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

Baseline Characteristics

Arm/Group Title		Lidocaine	Bupivacaine	Ropivacaine	Placebo (Saline)	Total
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
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.

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Reduction in Headache Days From Baseline to Month 8 of Treatment
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine	Bupivacaine	Ropivacaine	Placebo (Saline)
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

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	follow up appointments and chart review
Arm/Group Title	Lidocaine	Bupivacaine	Ropivacaine	Placebo (Saline)
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%)
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%)
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%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr.Nina Riggins
• Organization: UCSF
• Phone: 7028064831
• EMail: Nina.Riggins7@gmail.com

Publications:

Goadsby PJ, Zagami AS, Lambert GA. Neural processing of craniovascular pain: a synthesis of the central structures involved in migraine. Headache. 1991 Jun;31(6):365-71. doi: 10.1111/j.1526-4610.1991.hed3106365.x.

Piagkou M, Demesticha T, Troupis T, Vlasis K, Skandalakis P, Makri A, Mazarakis A, Lappas D, Piagkos G, Johnson EO. The pterygopalatine ganglion and its role in various pain syndromes: from anatomy to clinical practice. Pain Pract. 2012 Jun;12(5):399-412. doi: 10.1111/j.1533-2500.2011.00507.x. Epub 2011 Sep 29. Erratum In: Pain Pract. 2012 Nov;12(8):673.

Robbins MS, Robertson CE, Kaplan E, Ailani J, Charleston L 4th, Kuruvilla D, Blumenfeld A, Berliner R, Rosen NL, Duarte R, Vidwan J, Halker RB, Gill N, Ashkenazi A. The Sphenopalatine Ganglion: Anatomy, Pathophysiology, and Therapeutic Targeting in Headache. Headache. 2016 Feb;56(2):240-58. doi: 10.1111/head.12729. Epub 2015 Nov 30.

Mehta D, Leary MC, Yacoub HA, El-Hunjul M, Kincaid H, Koss V, Wachter K, Malizia D, Glassman B, Castaldo JE. The Effect of Regional Anesthetic Sphenopalatine Ganglion Block on Self-Reported Pain in Patients With Status Migrainosus. Headache. 2019 Jan;59(1):69-76. doi: 10.1111/head.13390. Epub 2018 Jul 25.

Binfalah M, Alghawi E, Shosha E, Alhilly A, Bakhiet M. Sphenopalatine Ganglion Block for the Treatment of Acute Migraine Headache. Pain Res Treat. 2018 May 7;2018:2516953. doi: 10.1155/2018/2516953. eCollection 2018.

Mojica J, Mo B, Ng A. Sphenopalatine Ganglion Block in the Management of Chronic Headaches. Curr Pain Headache Rep. 2017 Jun;21(6):27. doi: 10.1007/s11916-017-0626-8. Erratum In: Curr Pain Headache Rep. 2017 Nov 20;21(12 ):53. Mojica, Jeffery [corrected to Mojica, Jeffrey].

• 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