Bupivacaine and Epinephrine Injection Study

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06456255
• Other study ID #: H24-01167
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: July 2024
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: St. Paul's Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia
• Bleeding
• Paranasal Sinus Diseases
• Sinus Disease

Intervention

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.

Other:
• Sham injection
Punctures without any medication injected onto the septum

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amin Javer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total blood loss	Change in total blood between injection and sham group measured in millilitres	throughout study completion, one day study visit
Secondary	Surgical time	Change in surgical time between injection and sham group measure in minutes	throughout study completion, one day study visit
Secondary	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
Secondary	Postoperative bleeding	Change in postoperative bleeding between injection and sham group measured in mililiters	throughout study completion, one day study visit
Secondary	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