Bupivacaine and Epinephrine Injection Study

Amin Javer

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Sinus Disease; Bleeding; Anesthesia

Treatments: Other: Sham injection; Drug: Sensorcaine with Epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT06456255

H24-01167

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Injection

Experimental group

Description:

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

Treatment:

Drug: Sensorcaine with Epinephrine

Sham injection

Placebo Comparator group

Description:

- Sham injection (only puncture, no injecting anything)

Treatment:

Other: Sham injection