A Randomized Trial of a Sphenopalatine Ganglion Block With Bupivacaine for Acute Headache

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05707754
• Collaborator: (none)
• Enrollment: 220
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 7.5
• Patients Per Site Per Month: 29.5

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to compare the administration and dosage of bupivacaine for sphenopalatine ganglion (SPG) nerve block. The main question[s] it aims to answer are:

• Does a high dose (3ml) give more relief than a low dose (1ml)?

• Does bilateral administration give more relief than unilateral? Participants with headaches will be asked to lie down and have SPG block performed.

Researchers will compare dosage and administration to see how symptoms are reduced.

Condition or Disease	Intervention/Treatment	Phase
Sphenopalatine Ganglion Nerve Block	Drug: Bupivacaine; Device: angiocatheter	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Trial of a Sphenopalatine Ganglion Block With Bupivacaine for Acute Headache
• Anticipated Study Start Date: Feb 15, 2023
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: High dose with unilateral administration High dose (3ml) with unilateral administration of bupivacaine	Drug: Bupivacaine; Topically applied to sphenopalatine ganglion; Device: angiocatheter; Introduced into nose to reach sphenopalatine ganglion nerve
Active Comparator: High dose with bilateral administration High dose (3ml) with bilateral administration of bupivacaine	Drug: Bupivacaine; Topically applied to sphenopalatine ganglion; Device: angiocatheter; Introduced into nose to reach sphenopalatine ganglion nerve
Active Comparator: Low dose with unilateral administration Low dose (1ml) with unilateral administration of bupivacaine	Drug: Bupivacaine; Topically applied to sphenopalatine ganglion; Device: angiocatheter; Introduced into nose to reach sphenopalatine ganglion nerve
Active Comparator: Low dose with bilateral administration Low dose (1ml) with bilateral administration of bupivacaine	Drug: Bupivacaine; Topically applied to sphenopalatine ganglion; Device: angiocatheter; Introduced into nose to reach sphenopalatine ganglion nerve

Outcome Measures

Primary Outcome Measures

1. Sustained headache relief [48 hours]

   Achieve headache level = mild or none without rescue medication and maintain that for 48 horus

Secondary Outcome Measures

1. Satisfaction [48 hours]

   Participant wish to receive the same medication during a subsequent visit to the ED

Other Outcome Measures

1. Improvement in 0-10 pain scale [60 minutes]

   Pain scores will be ascertained prior to procedure and one hour after

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Present to ED for management of headache

• Headache is moderate or severe in intensity

Exclusion Criteria:

• Allergy to bupivacaine

• Nasal or sinus surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

• Montefiore Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Benjamin W. Friedman, MD, MD, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT05707754
• Other Study ID Numbers: 2022-14616
• First Posted: Feb 1, 2023
• Last Update Posted: Feb 1, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Benjamin W. Friedman, MD, MD, Montefiore Medical Center: Sphenopalatine ganglion nerve; peripheral nerve block; headache; migraine
• Additional relevant MeSH terms: Ganglion Cysts; Synovial Cyst; Headache; Bupivacaine

Study Results

No Results Posted as of Feb 1, 2023