Benign HeadachePhase 2NCT01785459
Bupivacaine for Benign Headache in the ED
A Phase 2 study testing 0.5% bupivacaine in people with Benign Headache, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Headache is a common chief complaint of patients presenting to the emergency department (ED), accounting for approximately 3 million ED visits per year. Headache treatment is often a source of frustration for both patients and providers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Benign Headache
- What is being tested?
- 0.5% bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jul 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years old
- Diagnosis of benign or primary headache
Who cannot join
- Hypersensitivity or allergy to bupivacaine (amide anesthetics) or prochlorperazine or other drugs in the same class, dopaminergic blockers.
- Overlying signs of infection at site of injection (Erythema, purulence, open skin)
- Neck pathology ( History of surgery to the cervical spine, History of surgical hardware in place, Documented disc abnormality, History of vertebral artery or carotid artery dissection, Torticollis)
- Intracranial abnormality/pathology (Tumor, Hemorrhage, Concussion or post concussive syndrome)
- History of increased intracranial pressure (ICP)
- A known history of extrapyramidal symptoms, dystonia, parkinsonism, tardive dyskinesia or neuroleptic malignant syndrome
- Known pregnancy
- Narcotic seeking patients as determined by the treating physician with optional assistance from medical record review and North Carolina Drug Database
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center
Charlotte, North Carolina, 28203
About this study
Official title: Treatment of Benign Headache in the Emergency Department Population With Lower Cervical Paraspinous Bupivacaine Injections Versus Anti-Emetic Treatment in the Emergency Department Population: Randomized Prospective Control Trial
Headache is a common chief complaint of patients presenting to the emergency department (ED), accounting for approximately 3 million ED visits per year. Headache treatment is often a source of frustration for both patients and providers. By the time patients with benign headaches arrive in the emergency department, they have often failed non-invasive therapeutic attempts and providers are often left with few therapeutic options. Treatment of benign headache varies between providers, often including systemic medications with a multitude of possible side effects. In recent years, there has been preliminary investigation into anesthetic injections for the undifferentiated headache patient presenting to the emergency department. It has been proposed that these patients presenting with benign headache might benefit from this novel treatment.
Patients that present to the Emergency Department with a diagnosis of benign or primary headache with serious or life-threatening causes of headache will be offered enrollment into the study.
Read more
Following consent, subjects will receive either 0.5% bupivacaine injected bilaterally in the paraspinal musculature of the cervical spine or the standard treatment with intravenous Prochlorperazine. The subjects will complete a validated pain scale before, and 20 minutes after injection. At twenty minutes post-injection, the subject will be reevaluated for symptoms. The subject will then be eligible for discharge or standard treatment at the discretion of the treating physician.
Subjects will be followed for 72 hours after enrollment for headache recurrence. Subjects will be monitored for immediate and post-discharge complications.
Read the detailed description
Headache is a common chief complaint of patients presenting to the emergency department (ED), accounting for approximately 3 million ED visits per year. Headache treatment is often a source of frustration for both patients and providers. By the time patients with benign headaches arrive in the emergency department, they have often failed non-invasive therapeutic attempts and providers are often left with few therapeutic options. Treatment of benign headache varies between providers, often including systemic medications with a multitude of possible side effects. Additionally, most headache cocktails require prolonged duration of treatment, occupying valuable bed space in increasingly busy emergency departments.
In recent years, there has been preliminary investigation into anesthetic injections for the undifferentiated headache patient presenting to the emergency department. It has been proposed that these patients presenting with benign headache might benefit from this novel treatment. Since 2003, paraspinal muscle injections of bupivacaine have been used in emergency department patients with encouraging results. The mechanism of action is not clearly understood; however, it has been proposed that these injections affect the trigeminocervical complex hypothesized to play an integral role in headache physiology, similar to the same mechanism behind greater occipital nerve blocks used by neurologists.
To the best of the investigators knowledge, there has never been a prospective double-blinded randomized control trial addressing this novel approach to headache management. Even so, the topic of using bupivacaine to inject the paraspinal musculature of the cervical spine has gained wider recognition over the past year. The topic has been discussed heavily on emergency medicine blogs and podcasts. Additionally, online videos have been posted to educate emergency medicine providers on the injection technique. According to retrospective literature, clinical efficacy was observed with a significant proportion of the patients receiving therapeutic effect. These studies, along with anecdotal experience with the procedure at the investigators institution, have led to great excitement concerning the possibility of a new approach to emergency department headache management. However, the topic still needs investigation with a well-designed prospective clinical trial to determine true clinical utility.
- Conditions
- Benign Headache
- Being tested
- 0.5% bupivacaine, Standard Care
- Keywords
- headache, migraine, bupivacaine
- Medical subject headings
- Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% bupivacaineDrug
The injection site will be prepared using common sterile technique with 2% chlorhexidine. 1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. Location would be approximately 1 cm superior to spinous process of C7 and approximately 2-3 cm laterally. The needle is inserted 1 to 1.5 inches into the paraspinous musculature at this level. A 27-gauge needle would be used to minimize tissue trauma and pain to the patient. Our method of injection is followed quite closely with the technique depicted in multiple retrospective studies. We chose to follow previous reported technique secondary to good clinical efficacy and impressive documented safety profile. Additionally, before injection, aspiration would be performed to lesson chance of intravascular injection.
Standard CareDrug
Also called Prochlorperazine, Reglan
10 mg Intravenous injection of Prochlorperazine
| Study group | Role | What they receive |
|---|---|---|
| standard care | Active comparator | intravenous Prochlorperazine Receives: Drug: Standard Care |
| treatment | Experimental | 0.5% bupivacaine Receives: Drug: 0.5% bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Length of stay will be calculated as total time of encounter as well as time from doctor encounter to disposition decision
Measured: enrollment day
Incidence of Immediate and Post-discharge Complications.
Subjects will be monitored for both immediate and post discharge complications up to 72 hours after enrollment that include: persistent local pain, bleeding, infection, and inadvertent intravascular injection resulting in seizure or possible cardiovascular collapse.
Measured: 72 hours
Secondary outcomes (1)
Symptomatic Relief of Headache
Symptomatic relief of headache will be measured by:
- Change from pre-intervention pain using a visual analog scale and ordinal scale:
- Headache relief
- Partial headache relief
- No headache relief
- Headache worsened
- Treatment failure, defined as requirement for additional medication administered in the ED due to incomplete pain relief from the paraspinous bupivacaine injections or the initial dose of intravenous prochlorperazine.
- Repeat visit for headache pain within 72 hour time period, excluding routine follow up care, determined by electronic medical record review and telephone follow up.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Unable to enroll adequate number of patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benign HeadacheStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean Fox, MD, Principal investigator, Carolinas Medical CenterCarey Nichols, MD, Principal investigator, Carolinas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785459
- Sponsor's protocol ID
- BBH-001
- Status last verified
- Mar 2019
- First submitted
- 3 Feb 2013
- Last updated
- 14 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Benign Headache in the Emergency Department Population With Lower Cervical Paraspinous Bupivacaine Injections Versus Anti-Emetic Treatment in the Emergency Department Population: Randomized Prospective Control Trial
- ClinicalTrials.gov ID
- NCT01785459
- Acronym / sponsor ID
- BBH-001
- Conditions
- Benign Headache
- Keywords
- headache, migraine, bupivacaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll adequate number of patients.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Posted 3 Apr 2019
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 common chief complaint of patients presenting to the emergency department (ED), accounting for approximately 3 million ED visits per year. Headache treatment is often a source of frustration for both patients and providers. By the time patients with benign headaches arrive in the emergency department, they have often failed non-invasive therapeutic attempts and providers are often left with few therapeutic options. Treatment of benign headache varies between providers, often including systemic medications with a multitude of possible side effects. In recent years, there has been preliminary investigation into anesthetic injections for the undifferentiated headache patient presenting to the emergency department. It has been proposed that these patients presenting with benign headache might benefit from this novel treatment.
Patients that present to the Emergency Department with a diagnosis of benign or primary headache with serious or life-threatening causes of headache will be offered enrollment into the study.
Following consent, subjects will receive either 0.5% bupivacaine injected bilaterally in the paraspinal musculature of the cervical spine or the standard treatment with intravenous Prochlorperazine. The subjects will complete a validated pain scale before, and 20 minutes after injection. At twenty minutes post-injection, the subject will be reevaluated for symptoms. The subject will then be eligible for discharge or standard treatment at the discretion of the treating physician.
Subjects will be followed for 72 hours after enrollment for headache recurrence. Subjects will be monitored for immediate and post-discharge complications.
Detailed description
Headache is a common chief complaint of patients presenting to the emergency department (ED), accounting for approximately 3 million ED visits per year. Headache treatment is often a source of frustration for both patients and providers. By the time patients with benign headaches arrive in the emergency department, they have often failed non-invasive therapeutic attempts and providers are often left with few therapeutic options. Treatment of benign headache varies between providers, often including systemic medications with a multitude of possible side effects. Additionally, most headache cocktails require prolonged duration of treatment, occupying valuable bed space in increasingly busy emergency departments.
In recent years, there has been preliminary investigation into anesthetic injections for the undifferentiated headache patient presenting to the emergency department. It has been proposed that these patients presenting with benign headache might benefit from this novel treatment. Since 2003, paraspinal muscle injections of bupivacaine have been used in emergency department patients with encouraging results. The mechanism of action is not clearly understood; however, it has been proposed that these injections affect the trigeminocervical complex hypothesized to play an integral role in headache physiology, similar to the same mechanism behind greater occipital nerve blocks used by neurologists.
To the best of the investigators knowledge, there has never been a prospective double-blinded randomized control trial addressing this novel approach to headache management. Even so, the topic of using bupivacaine to inject the paraspinal musculature of the cervical spine has gained wider recognition over the past year. The topic has been discussed heavily on emergency medicine blogs and podcasts. Additionally, online videos have been posted to educate emergency medicine providers on the injection technique. According to retrospective literature, clinical efficacy was observed with a significant proportion of the patients receiving therapeutic effect. These studies, along with anecdotal experience with the procedure at the investigators institution, have led to great excitement concerning the possibility of a new approach to emergency department headache management. However, the topic still needs investigation with a well-designed prospective clinical trial to determine true clinical utility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care | Active comparator | Drug: Standard Careintravenous Prochlorperazine |
| treatment | Experimental | Drug: 0.5% bupivacaine0.5% bupivacaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-65 years old
- Diagnosis of benign or primary headache
Key exclusion criteria (8 listed)
- Hypersensitivity or allergy to bupivacaine (amide anesthetics) or prochlorperazine or other drugs in the same class, dopaminergic blockers.
- Overlying signs of infection at site of injection (Erythema, purulence, open skin)
- Neck pathology ( History of surgery to the cervical spine, History of surgical hardware in place, Documented disc abnormality, History of vertebral artery or carotid artery dissection, Torticollis)
- Intracranial abnormality/pathology (Tumor, Hemorrhage, Concussion or post concussive syndrome)
- History of increased intracranial pressure (ICP)
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% bupivacaineThe injection site will be prepared using common sterile technique with 2% chlorhexidine. 1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. Location would be approximately 1 cm superior to spinous process of C7 and approximately 2-3 cm laterally. The needle is inserted 1 to 1.5 inches into the paraspinous musculature at this level. A 27-gauge needle would be used to minimize tissue trauma and pain to the patient. Our method of injection is followed quite closely with the technique depicted in multiple retrospective studies. We chose to follow previous reported technique secondary to good clinical efficacy and impressive documented safety profile. Additionally, before injection, aspiration would be performed to lesson chance of intravascular injection. | Drug | treatment |
| Standard CareAlso: Prochlorperazine, Reglan10 mg Intravenous injection of Prochlorperazine | Drug | standard care |
Primary outcome
Length of Stay
Time frame: enrollment day
Length of stay will be calculated as total time of encounter as well as time from doctor encounter to disposition decision
Incidence of Immediate and Post-discharge Complications.
Time frame: 72 hours
Subjects will be monitored for both immediate and post discharge complications up to 72 hours after enrollment that include: persistent local pain, bleeding, infection, and inadvertent intravascular injection resulting in seizure or possible cardiovascular collapse.
1 secondary outcome
Symptomatic Relief of Headache
Time frame: 20 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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. This study is not recruiting at the moment.
Sean Fox, MD principal investigator
Carolinas Medical Center
Carey Nichols, MD principal investigator
Carolinas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.5% bupivacaine in people with Benign Headache, run by Wake Forest University Health Sciences 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 14 Jul 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay (time frame: enrollment day). The study lists 2 primary outcomes in all. 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 14 Jul 2022.