Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures

Phase 4

Completed

• Conditions: Eyelid Abscess; Eyelid Papilloma; Eyelid Boil; Eyelid Tumor; Eyelid Bump; Eyelid Deformity; Anesthesia, Local; Ophthalmology
• Interventions: Drug: 0.9% Bacteriostatic Local Anesthetic Injection; Procedure: Eyelid Lesion Removal

• Registration Number: NCT05294640
• Lead Sponsor: University of California, San Francisco

Brief Summary

The investigators aim to assess whether bacteriostatic saline provides the same level of anesthesia as traditional local anesthesia while reducing pain associated with medication infusion in minor eyelid procedures

Detailed Description

Benzoyl alcohol is an aromatic alcohol that has been used in healthcare primarily as an antibacterial preservative agent in bacteriostatic saline. It has also been shown to have anesthetic properties, and has been demonstrated to cause less pain with infusion compared to lidocaine, while maintaining adequate pain relief. The use of bacteriostatic saline alone as an anesthetic for incisional procedures in the periocular area has not yet been studied. The purpose of this study was to determine whether bacteriostatic saline provides an adequate level of anesthesia for minor in-office eyelid procedures while allowing for reducing pain associated with medication infusion compared with traditional local anesthetic agents. To assess this, the investigators will recruit 150 patients aged 18 or older undergoing minor eyelid procedures including eyelid biopsies, chalazion removal from outpatient oculoplastics clinics at UCSF. Patients will be randomized in a 1:1 fashion to undergo local anesthetic with either 1% lidocaine with 1:100,000 epinephrine or 0.9% bacteriostatic saline. Primary outcome measure will be pain level on a scale of 1-10 with regards to injection and procedure itself. These will be compared between the two groups. The investigators hypothesize that bacteriostatic saline is superior to lidocaine with epinephrine in terms of pain with injection, but will result in a similar pain level during the procedure.

Study Timeline

• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-23
• Study First Posted: 2022-03-24
• Study Start: 2022-05-17
• Primary Completion: 2023-02-21
• Study Completion: 2023-02-21
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

1. Age >=18 years old
2. Undergoing clinic-based periocular procedure

Exclusion Criteria

1. Any other topical, oral or intravenous sedating medications given alongside procedure
2. Allergy to saline, lidocaine or epinephrine
3. Unable to provide consent due to cognitive impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bacteriostatic Saline as Local Anesthesia	0.9% Bacteriostatic Local Anesthetic Injection	Patients receiving bacteriostatic saline as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department
Bacteriostatic Saline as Local Anesthesia	Eyelid Lesion Removal	Patients receiving bacteriostatic saline as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department
Lidocaine with Epinephrine as Local Anesthesia	Eyelid Lesion Removal	Patients receiving lidocaine with epinephrine as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department

Primary Outcome Measures

Name	Time	Method
Pain on injection	5 minutes	Pain on a scale of 0-10 during injection process (0 being no pain, 10 being worst pain ever experienced). These will be patient-reported verbally and recorded immediately after injection.
Pain of procedure	10 minutes	Pain on a scale of 0-10 during procedure (0 being no pain, 10 being worst pain ever experienced). These will be patient-reported verbally and recorded immediately after procedure.

Secondary Outcome Measures

Name	Time	Method
Additional Anesthesia	10 minutes	Need for additional anesthesia to complete procedure
Bleeding level	10 minutes	Physician-assessed level of bleeding after procedure (mild, moderate, severe). These will be physician-reported verbally and recorded immediately after procedure.

Trial Locations

Locations (1)

University of California at San Francisco; 🇺🇸 San Francisco, California, United States