HeadachePhase 3NCT06937385
0.5% Bupivacaine Lower Cervical Intramuscular Injection vs IV Medications for Headache Treatment
A Phase 3 study testing 0.5% Bupivacaine HCl and standard IV treatment for headache in people with Headache and Migraine, run by HCA Florida North Florida Hospital at 1 site in United States.
Trial summary
Headache is a frequent chief complaint among patients presenting to the Emergency Department (ED), accounting for 2.1 million visits annually in the United States. Often, individuals resort to ED care only after over-the-counter or home remedies have failed, leading to the predominant use of intravenous (IV)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache, Migraine, Tension Headache
- What is being tested?
- 0.5% Bupivacaine HCl and standard IV treatment for headache
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 1 May 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has to be able to provide own consent
- English-speaking only
- Non traumatic headache with VAS pain score of 5 or above out of 10
Who cannot join
- traumatic headache
- Confused patients
- allergy to bupivacaine
- infection over injection site
- recent neck surgery
- hemodynamically unstable
Show all 10Show fewer
- bleeding disorder
- anticoagulation use
- pregnant, lactating women
- prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
HCA Florida north florida Hospital
Gainesville, Florida, 32605
About this study
Official title: Randomized, Prospective, Open-label, Controlled Trial of 0.5% Bupivacaine Lower Cervical Intramuscular Injection vs IV Medications in Treatment of Non-Traumatic Headache in the Emergency Department
Headache is a frequent chief complaint among patients presenting to the Emergency Department (ED), accounting for 2.1 million visits annually in the United States. Often, individuals resort to ED care only after over-the-counter or home remedies have failed, leading to the predominant use of intravenous (IV) medications in the ED, including NSAIDs, triptans, neuroleptics, antiepileptics, and dopaminergic antagonists. Unfortunately, these pharmacologic treatments frequently induce side effects such as cognitive impairment, extrapyramidal reactions, and the potential for medication dependency. In the ED, patients frequently require concurrent administration of multiple systemic medications to achieve satisfactory pain relief, thereby elevating the risk associated with medication use. Despite these medication regimens, a significant portion of patients continue to experience inadequate pain relief. Consequently, the search for an optimal headache therapy-characterized by rapid and effective pain relief, long lasting results, minimal side effects, and allows for rapid ED patient turnover-continues to be a popular area of research in emergency medicine. The investigators plan to evaluate the use of 0.5% bupivacaine cervical IM injection at the c6-7 location for the treatment of non traumatic headaches using a non-inferiority design, randomized, prospective, open-label, controlled trial comparing it to physicians choice of intravenous medications in treatment of headache in the Emergency Department at North Florida Hospital.
- Conditions
- Headache, Migraine, Tension Headache, Occipital Neuralgia
- Being tested
- 0.5% Bupivacaine HCl, standard IV treatment for headache
- Keywords
- headache, bupivicaine, cervical injection, paraspinous injection
- Medical subject headings
- Headache, Migraine Disorders, Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% Bupivacaine HClDrug
Also called cervical IM injection
bilateral cervical injections of 0.5% bupivacaine into the paraspinous muscle at the c6-7 location for headache treatment
standard IV treatment for headacheDrug
physicians choice of IV medications in treatment of headache
| Study group | Role | What they receive |
|---|---|---|
| Intravenous medication | Active comparator | physicians choice of intravenous medication for headache treatment Receives: Drug: standard IV treatment for headache |
| cervical IM injection | Experimental | bilateral cervical injections of 0.5% bupivacaine into the paraspinous muscle at the c6-7 location Receives: Drug: 0.5% Bupivacaine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale pain score 0-10
Pain score at 30 minutes and 24 hours after treatment. 0 being no pain and 10 being the worse pain possible.
Measured: 24 hours
Secondary outcomes (2)
Emergency department length of stay
Duration that patients stayed in the Emergency department for
Measured: 24 hours
Need for additional medications
Whether an additional medication was given to patients after 30 minutes
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HCA Florida North Florida Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengqiu Zhou, HCA Florida North Florida Hospital
- Investigators
- Robyn Hoelle, MD, Principal investigator, HCA north florida hospital emergency department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937385
- Sponsor's protocol ID
- 2024-302
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will not be shared to protect patient safety and their healthcare information.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective, Open-label, Controlled Trial of 0.5% Bupivacaine Lower Cervical Intramuscular Injection vs IV Medications in Treatment of Non-Traumatic Headache in the Emergency Department
- ClinicalTrials.gov ID
- NCT06937385
- Acronym / sponsor ID
- 2024-302
- Conditions
- Headache, Migraine, Tension Headache, Occipital Neuralgia
- Keywords
- headache, bupivicaine, cervical injection, paraspinous injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HCA Florida North Florida HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Headache is a frequent chief complaint among patients presenting to the Emergency Department (ED), accounting for 2.1 million visits annually in the United States. Often, individuals resort to ED care only after over-the-counter or home remedies have failed, leading to the predominant use of intravenous (IV) medications in the ED, including NSAIDs, triptans, neuroleptics, antiepileptics, and dopaminergic antagonists. Unfortunately, these pharmacologic treatments frequently induce side effects such as cognitive impairment, extrapyramidal reactions, and the potential for medication dependency. In the ED, patients frequently require concurrent administration of multiple systemic medications to achieve satisfactory pain relief, thereby elevating the risk associated with medication use. Despite these medication regimens, a significant portion of patients continue to experience inadequate pain relief. Consequently, the search for an optimal headache therapy-characterized by rapid and effective pain relief, long lasting results, minimal side effects, and allows for rapid ED patient turnover-continues to be a popular area of research in emergency medicine. The investigators plan to evaluate the use of 0.5% bupivacaine cervical IM injection at the c6-7 location for the treatment of non traumatic headaches using a non-inferiority design, randomized, prospective, open-label, controlled trial comparing it to physicians choice of intravenous medications in treatment of headache in the Emergency Department at North Florida Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous medication | Active comparator | Drug: standard IV treatment for headachephysicians choice of intravenous medication for headache treatment |
| cervical IM injection | Experimental | Drug: 0.5% Bupivacaine HClbilateral cervical injections of 0.5% bupivacaine into the paraspinous muscle at the c6-7 location |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has to be able to provide own consent
- English-speaking only
- Non traumatic headache with VAS pain score of 5 or above out of 10
Key exclusion criteria (10 listed)
- traumatic headache
- Confused patients
- allergy to bupivacaine
- infection over injection site
- recent neck surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5% Bupivacaine HClAlso: cervical IM injectionbilateral cervical injections of 0.5% bupivacaine into the paraspinous muscle at the c6-7 location for headache treatment | Drug | cervical IM injection |
| standard IV treatment for headachephysicians choice of IV medications in treatment of headache | Drug | Intravenous medication |
Primary outcome
Visual analog scale pain score 0-10
Time frame: 24 hours
Pain score at 30 minutes and 24 hours after treatment. 0 being no pain and 10 being the worse pain possible.
2 secondary outcomes
Emergency department length of stay
Time frame: 24 hours
Need for additional medications
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No. individual participant data will not be shared to protect patient safety and their healthcare information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robyn Hoelle, MD principal investigator
HCA north florida hospital emergency department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.5% Bupivacaine HCl and standard IV treatment for headache in people with Headache and Migraine, run by HCA Florida North Florida Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zhengqiu zhou, MD (8593686486, zhengqiu.zhou@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale pain score 0-10 (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.