Your session is about to expire
← Back to Search
Local Anesthetic
Nerve Block for Headaches
Phase 1
Recruiting
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes
Awards & highlights
Study Summary
This trial will test different doses and ways to administer a nerve block to reduce headache symptoms. Participants will lie down for the procedure. #clinicaltrial #headache #bupivacaine
Who is the study for?
This trial is for individuals who come to the emergency department with moderate or severe headaches. They must not have allergies to bupivacaine or a history of nasal or sinus surgery.Check my eligibility
What is being tested?
The study tests different doses and methods of administering bupivacaine, a local anesthetic, for sphenopalatine ganglion (SPG) nerve block in headache relief. It compares high dose (3ml) versus low dose (1ml), and bilateral versus unilateral administration.See study design
What are the potential side effects?
Bupivacaine may cause side effects such as numbness at the injection site, dizziness, nausea, weakness, or increased heart rate. More serious reactions are rare but can include seizures or allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants demonstrating sustained headache relief
Secondary outcome measures
Number of participants demonstrating satisfaction with the procedure/medication
Other outcome measures
Number of participants demonstrating improvement in 0-10 pain scale
Trial Design
4Treatment groups
Active Control
Group I: High dose with unilateral administrationActive Control2 Interventions
High dose (3ml) with unilateral administration of bupivacaine
Group II: High dose with bilateral administrationActive Control2 Interventions
High dose (3ml) with bilateral administration of bupivacaine
Group III: Low dose with unilateral administrationActive Control2 Interventions
Low dose (1ml) with unilateral administration of bupivacaine
Group IV: Low dose with bilateral administrationActive Control2 Interventions
Low dose (1ml) with bilateral administration of bupivacaine
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
581,976 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to bupivacaine.You have had surgery on your nose or sinuses in the past.You have a headache that is fairly strong or very strong.
Research Study Groups:
This trial has the following groups:- Group 1: High dose with unilateral administration
- Group 2: High dose with bilateral administration
- Group 3: Low dose with unilateral administration
- Group 4: Low dose with bilateral administration
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Federal Drug Administration approved high dosage with single-sided administration?
"Due to the relative lack of evidence regarding its efficacy and safety, High dose with unilateral administration was assigned a rating of 1."
Answered by AI
Are there any vacancies in this research study for participants?
"Clinicaltrials.gov data indicates that this medical study is not recruiting patients at the moment; it was first posted on February 15th 2023 and last updated January 22nd of the same year. Despite this, there are currently 158 other investigations actively looking for participants to enroll in their trials."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger