Bupivacaine and Epinephrine Injection Study

ConditionsSinus Disease Anesthesia Bleeding

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Sensorcaine with Epinephrine
Drug
The combination contains 0.25% bupivacaine hydrochloride (2.5 mg/mL) and epinephrine bitartrate \[(1:200,000) 5 mcg/mL\] per vial.
Sham injection
Other intervention
Punctures without any medication injected onto the septum

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: InjectionExperimental treatment 1 intervention

Group B: Sham injectionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame