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NCT Number: NCT06456255

Bupivacaine and Epinephrine Injection Study

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.

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Key information

Conditions

Sinus Disease Anesthesia Bleeding Hemorrhage Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

St.Paul's Hospital Sinus Center

Vancouver, British Columbia, V6Z 1Y6, Canada

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Sham Injection

Other

Punctures without any medication injected onto the septum

Primary outcomes

  1. Boezzart bleeding score

    Time frame: 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 outcomes

  1. Total blood loss

    Time frame: throughout study completion, one day study visit

    Change in total blood between injection and sham group measured in millilitres

  2. Surgical time

    Time frame: throughout study completion, one day study visit

    Change in surgical time between injection and sham group measure in minutes

  3. Mean arterial pressure (MAP)

    Time frame: 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)

  4. Postoperative bleeding

    Time frame: throughout study completion, one day study visit

    Change in postoperative bleeding between injection and sham group measured in mililiters

  5. Postoperative pain

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Amin Javer

CONTACT

[email protected]

6048069926

Sponsors and collaborators

Lead sponsor

Amin Javer

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2024
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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