Bupivacaine and Epinephrine Injection Study

Bupivacaine With Epinephrine vs Sham Injections During Endoscopic Sinus Surgery: a Double Blind, Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Bleeding; Anesthesia; Sinus Disease
• Intervention / Treatment: Drug: Sensorcaine with Epinephrine; Other: Sham injection

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Amin Javer; Phone Number: 6048069926; Email: sinusdoc@me.com

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Recruiting
      • St.Paul's Hospital Sinus Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Injection; - Injection 0.25% bupivacaine with 1:200,000 epinephrine	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.
Placebo Comparator: Sham injection; - Sham injection (only puncture, no injecting anything)	Other: Sham injection; Punctures without any medication injected onto the septum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	throughout study completion, one day study visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total blood loss	Change in total blood between injection and sham group measured in millilitres	throughout study completion, one day study visit
Surgical time	Change in surgical time between injection and sham group measure in minutes	throughout study completion, one day study visit
Mean arterial pressure (MAP)	Change in Mean arterial pressure (MAP) between injection and sham group measured in millimeters of mercury (mm Hg)	throughout study completion, one day study visit
Postoperative bleeding	Change in postoperative bleeding between injection and sham group measured in mililiters	throughout study completion, one day study visit
Postoperative pain	Change in postoperative pain between injection and sham group measured with a Visual Analog Scale (VAS) grading from 0 (no pain) to 5 (severe pain)	throughout study completion, one day study visit

Collaborators and Investigators

• Sponsor: Amin Javer

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: bupivacaine; epinephrine; endoscopic sinus surgery
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Neurotransmitter Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Epinephrine
• Other Study ID Numbers: H24-01167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No