Sinus DiseasePhase 2/3NCT06456255
Bupivacaine and Epinephrine Injection Study
A Phase 2/3 study testing Sensorcaine with Epinephrine in people with Sinus Disease and Anesthesia, run by Amin Javer at 1 site in Canada.
Trial summary
Endoscopic sinus surgery (ESS) is a common otolaryngologic procedure that aims to remove the partitions that separate the sinus cavities, remove inflamed tissue, and optimize the sinuses for topical medication use. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sinus Disease, Anesthesia, Bleeding
- What is being tested?
- Sensorcaine with Epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2024to Jul 2025
- Phase
- Phase 2/3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 years or older
- Scheduled for primary ESS (including septoplasty)
Who cannot join
- Cystic fibrosis
- Systemic vasculitis or any bleeding disorders
- Known or suspected hypersensitivity to bupivacaine or epinephrine
- Previous sinus surgery
- Inhaled drug use (i.e., cocaine) in the preceding 6 months
- Nasal tumors
Show all 9Show fewer
- Patients on antiarrhythmics.
- Patients with history of severe liver illness.
- Patients identified as high-risk for complications during preoperative assessment with the anesthesiologist (e.g. untreated hypertension, ischemic heart disease, cerebral vascular insufficiency, heart block, peripheral vascular disorder, uncontrolled hyperthyroidism and diabetes)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St.Paul's Hospital Sinus Center
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Bupivacaine With Epinephrine vs Sham Injections During Endoscopic Sinus Surgery: a Double Blind, Randomized Controlled Trial
Endoscopic sinus surgery (ESS) is a common otolaryngologic procedure that aims to remove the partitions that separate the sinus cavities, remove inflamed tissue, and optimize the sinuses for topical medication use. In this procedure, the surgeon will inject a combination of drugs, local anesthetics, and vasoconstrictors, to reduce bleeding and improve visualization. However, previous studies have shown similar results when injected with only saline. In this study, investigators want to determine if the injection of local anesthesic+vasoconstrictor compared to no injection at all makes any difference in improving the surgeon's visualization during an ESS.
- Conditions
- Sinus Disease, Anesthesia, Bleeding
- Being tested
- Sensorcaine with Epinephrine, Sham injection
- Keywords
- endoscopic sinus surgery, bupivacaine, epinephrine
- Medical subject headings
- Paranasal Sinus Diseases, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensorcaine with EpinephrineDrug
The combination contains 0.25% bupivacaine hydrochloride (2.5 mg/mL) and epinephrine bitartrate [(1:200,000) 5 mcg/mL] per vial.
Sham injectionOther
Punctures without any medication injected onto the septum
| Study group | Role | What they receive |
|---|---|---|
| Injection | Experimental | - Injection 0.25% bupivacaine with 1:200,000 epinephrine Receives: Drug: Sensorcaine with Epinephrine |
| Sham injection | Placebo comparator | - Sham injection (only puncture, no injecting anything) Receives: Other: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boezzart bleeding score
Change in mean surgical field quality as determined by the Boezzart bleeding score. Boezaart score of 0 indicates no bleeding, whereas the maximum score of 5 indicates severe bleeding (constant suctioning required).
Measured: throughout study completion, one day study visit
Secondary outcomes (5)
Total blood loss
Change in total blood between injection and sham group measured in millilitres
Measured: throughout study completion, one day study visit
Surgical time
Change in surgical time between injection and sham group measure in minutes
Measured: throughout study completion, one day study visit
Mean arterial pressure (MAP)
Change in Mean arterial pressure (MAP) between injection and sham group measured in millimeters of mercury (mm Hg)
Measured: throughout study completion, one day study visit
Postoperative bleeding
Change in postoperative bleeding between injection and sham group measured in mililiters
Measured: throughout study completion, one day study visit
Postoperative pain
Change in postoperative pain between injection and sham group measured with a Visual Analog Scale (VAS) grading from 0 (no pain) to 5 (severe pain)
Measured: throughout study completion, one day study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start15 Nov 2024
- Primary completionMay 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus DiseaseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We propose a double-blind, parallel arm, randomized controlled trial evaluating whether injecting 0.25% bupivacaine with 1:200,000 epinephrine is superior to no injection (sham procedure) during ESS.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amin Javer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amin Javer, St. Paul's Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456255
- Sponsor's protocol ID
- H24-01167
- Status last verified
- May 2025
- First submitted
- 27 May 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupivacaine With Epinephrine vs Sham Injections During Endoscopic Sinus Surgery: a Double Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06456255
- Acronym / sponsor ID
- H24-01167
- Conditions
- Sinus Disease, Anesthesia, Bleeding
- Keywords
- endoscopic sinus surgery, bupivacaine, epinephrine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Amin JaverUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 13 Jun 2024 (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.
Endoscopic sinus surgery (ESS) is a common otolaryngologic procedure that aims to remove the partitions that separate the sinus cavities, remove inflamed tissue, and optimize the sinuses for topical medication use. In this procedure, the surgeon will inject a combination of drugs, local anesthetics, and vasoconstrictors, to reduce bleeding and improve visualization. However, previous studies have shown similar results when injected with only saline. In this study, investigators want to determine if the injection of local anesthesic+vasoconstrictor compared to no injection at all makes any difference in improving the surgeon's visualization during an ESS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- We propose a double-blind, parallel arm, randomized controlled trial evaluating whether injecting 0.25% bupivacaine with 1:200,000 epinephrine is superior to no injection (sham procedure) during ESS.
| Arm | Type | Receives |
|---|---|---|
| Injection | Experimental | Drug: Sensorcaine with Epinephrine- Injection 0.25% bupivacaine with 1:200,000 epinephrine |
| Sham injection | Placebo comparator | Other: Sham injection- Sham injection (only puncture, no injecting anything) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 19 years or older
- Scheduled for primary ESS (including septoplasty)
Key exclusion criteria (9 listed)
- Cystic fibrosis
- Systemic vasculitis or any bleeding disorders
- Known or suspected hypersensitivity to bupivacaine or epinephrine
- Previous sinus surgery
- Inhaled drug use (i.e., cocaine) in the preceding 6 months
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 |
|---|---|---|
| Sensorcaine with EpinephrineThe combination contains 0.25% bupivacaine hydrochloride (2.5 mg/mL) and epinephrine bitartrate [(1:200,000) 5 mcg/mL] per vial. | Drug | Injection |
| Sham injectionPunctures without any medication injected onto the septum | Other | Sham injection |
Primary outcome
Boezzart bleeding score
Time frame: throughout study completion, one day study visit
Change in mean surgical field quality as determined by the Boezzart bleeding score. Boezaart score of 0 indicates no bleeding, whereas the maximum score of 5 indicates severe bleeding (constant suctioning required).
5 secondary outcomes
Total blood loss
Time frame: throughout study completion, one day study visit
Surgical time
Time frame: throughout study completion, one day study visit
Mean arterial pressure (MAP)
Time frame: throughout study completion, one day study visit
Postoperative bleeding
Time frame: throughout study completion, one day study visit
Postoperative pain
Time frame: throughout study completion, one day study visit
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 15 May 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sensorcaine with Epinephrine in people with Sinus Disease and Anesthesia, run by Amin Javer at 1 site in Canada.
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 9 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: looking for participants now, as of the sponsor's last update on 15 May 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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 Amin Javer (6048069926, sinusdoc@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boezzart bleeding score (time frame: throughout study completion, one day study visit). 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 15 May 2025.