Bupivacaine and Epinephrine Injection Study

Last updated: May 12, 2025
Sponsor: Amin Javer
Overall Status: Active - Recruiting

Phase

2/3

Condition

Anesthesia

Sinus Infections

Sinusitis

Treatment

Sham injection

Sensorcaine with Epinephrine

Clinical Study ID

NCT06456255
H24-01167
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 19 years or older

  • Scheduled for primary ESS (including septoplasty)

Exclusion

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 assessmentwith the anesthesiologist (e.g. untreated hypertension, ischemic heart disease,cerebral vascular insufficiency, heart block, peripheral vascular disorder,uncontrolled hyperthyroidism and diabetes)

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Sham injection
Phase: 2/3
Study Start date:
November 15, 2024
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • St.Paul's Hospital Sinus Center

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Active - Recruiting

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