Recruiting
Phase 2
Phase 3

Bupivacaine & Epinephrine

Sponsor:

Amin Javer

Code:

NCT06456255

Conditions

Sinus Disease

Anesthesia

Bleeding

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Sensorcaine with Epinephrine

Sham injection

Study Details

Brief 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. 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

Study ID

NCT06456255

Start date

Nov 15, 2024

Status verified date

May, 2025

Completion date

Jul, 2025

Anticipated

Primary completion date

May, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 19 years or older
  • Scheduled for primary ESS (including septoplasty)

Exclusion Criteria:

  • 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
  • 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)

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Injection

- Injection 0.25% bupivacaine with 1:200,000 epinephrine

placebo comparator: Sham injection

- Sham injection (only puncture, no injecting anything)

Interventions

Sensorcaine with Epinephrine

The combination contains 0.25% bupivacaine hydrochloride (2.5 mg/mL) and epinephrine bitartrate \[(1:200,000) 5 mcg/mL\] per vial.

Sham injection

Punctures without any medication injected onto the septum

Primary outcome measure

  • Boezzart bleeding score [ Time Frame: throughout study completion, one day study visit ]

Central Contacts and Locations

Central contacts

Amin Javer

6048069926sinusdoc@me.com

Locations

St.Paul's Hospital Sinus Center

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

More Information

Sponsor

Amin Javer

Last update posted

May 15, 2025

Last verified

May, 2025

Keywords

  • endoscopic sinus surgery
  • bupivacaine
  • epinephrine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Amin Javer on 2025-05-15.