Bupivacaine and Epinephrine Injection Study

NCT06456255 | Recruiting Phase 2

• 1 other identifier: H24-01167
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinus Disease; Anesthesia; Bleeding

Keywords

endoscopic sinus surgery; bupivacaine; epinephrine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Total blood loss

  throughout study completion, one day study visit

• Surgical time

  throughout study completion, one day study visit

• Mean arterial pressure (MAP)

  throughout study completion, one day study visit

• Postoperative bleeding

  throughout study completion, one day study visit

• Postoperative pain

  throughout study completion, one day study visit

Study Arms (2)

Injection

EXPERIMENTAL

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

Drug: Sensorcaine with Epinephrine

Sham injection

PLACEBO COMPARATOR

\- Sham injection (only puncture, no injecting anything)

Other: Sham injection

Interventions

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.

Injection

Sham injection OTHER

Punctures without any medication injected onto the septum

Sham injection

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19 years or older
• Scheduled for primary ESS (including septoplasty)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Amin Javer: lead

Study Sites (1)

St.Paul's Hospital Sinus Center

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

MeSH Terms

Conditions

Paranasal Sinus Diseases; Hemorrhage

Interventions

Bupivacaine; Epinephrine; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Amin Javer

CONTACT

6048069926; sinusdoc@me.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: We propose a double-blind, parallel arm, randomized controlled trial evaluating whether injecting 0.25% bupivacaine with 1:200,000 epinephrine is superior to no injection (sham procedure) during ESS.

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 13, 2024
• Study Start: November 15, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)