Bupivacaine and Epinephrine Injection Study

Phase 2

Recruiting

• Conditions: Anesthesia; Sinus Disease; Bleeding
• Interventions: Other: Sham injection; Drug: Sensorcaine with Epinephrine

• Registration Number: NCT06456255
• Lead Sponsor: Amin Javer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-27
• Study First Submitted QC: 2024-06-07
• Study First Posted: 2024-06-13
• Study Start: 2024-11-15
• Status Verified: 2025-05
• Primary Completion: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham injection	Sham injection	- Sham injection (only puncture, no injecting anything)
Injection	Sensorcaine with Epinephrine	- Injection 0.25% bupivacaine with 1:200,000 epinephrine

Primary Outcome Measures

Name	Time	Method
Boezzart bleeding score	throughout study completion, one day study visit	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).

Secondary Outcome Measures

Name	Time	Method
Postoperative bleeding	throughout study completion, one day study visit	Change in postoperative bleeding between injection and sham group measured in mililiters
Mean arterial pressure (MAP)	throughout study completion, one day study visit	Change in Mean arterial pressure (MAP) between injection and sham group measured in millimeters of mercury (mm Hg)
Postoperative pain	throughout study completion, one day study visit	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)
Total blood loss	throughout study completion, one day study visit	Change in total blood between injection and sham group measured in millilitres
Surgical time	throughout study completion, one day study visit	Change in surgical time between injection and sham group measure in minutes

Trial Locations

Locations (1)

St.Paul's Hospital Sinus Center; 🇨🇦 Vancouver, British Columbia, Canada