Bupivacaine and Epinephrine Injection Study

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorAmin Javer

About this 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.

Eligibility criteria

Qualifiers

Age 19 years or older

Scheduled for primary ESS (including septoplasty)

Disqualifiers

Cystic fibrosis

Systemic vasculitis or any bleeding disorders

Known or suspected hypersensitivity to bupivacaine or epinephrine

Previous sinus surgery

Trial design

Treatments tested in this trial

  • Sensorcaine with Epinephrine
  • Sham injection

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Amin Javer

Lead sponsor

St. Paul's Hospital, Canada

Sponsor institution