Sphenopalatine Ganglion Block Study

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

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.

Study Overview

• Status: Completed
• Conditions: Sphenopalatine Ganglion Nerve Block
• Intervention / Treatment: Drug: Bupivacaine; Device: angiocatheter

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants demonstrating sustained headache relief	A standard ordinal headache intensity scale will be used for participants to describe their headache as either "severe", "moderate", "mild", or "none". The number of participants who are able to achieve a headache level of "mild" or "none" in the ED within 30 minutes of procedure/medication administration and without requiring additional analgesic medication, and not relapsing to a headache level worse than "mild" during the 48 hours after medication administration, will be determined	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants demonstrating satisfaction with the procedure/medication	Satisfaction with the procedure/medication as evidenced by the number of participants who provide an affirmative response to the question "Do you want to receive the same procedure/medication the next time you come to the ER with migraine?"	48 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants demonstrating improvement in 0-10 pain scale	Pain will be assessed using an 11-point numerical rating scale (NRS) as recommended for use in migraine research by the International Headache Society. The NRS scale asks subjects to assign their pain a number between 0 and 10, with 0 = no pain and 10 = worst pain imaginable. Pain scores will be ascertained prior to procedure and at one hour	60 minutes

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Benjamin Friedman, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: January 22, 2023
• First Submitted That Met QC Criteria: January 22, 2023
• First Posted (Actual): February 1, 2023

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Migraine; Headache; Peripheral nerve block; Sphenopalatine ganglion nerve
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Connective Tissue Diseases; Mucinoses; Ganglion Cysts; Synovial Cyst; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2022-14616

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes