MedTrace Logo

Bupivacaine and Epinephrine Injection Study

NCT06456255 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-05-15

No results posted yet for this 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.

Conditions

Interventions

DRUG

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.

OTHER

Sham injection

Punctures without any medication injected onto the septum

Sponsors & Collaborators

  • Amin Javer

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2025-05-31
Completion
2025-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06456255 on ClinicalTrials.gov