Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

Conditions: Eyelid Abscess; Anesthesia, Local; Eyelid Papilloma; Ophthalmology; Eyelid Boil; Eyelid Bump; Eyelid Tumor; Eyelid Deformity

Treatments: Drug: 1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection; Drug: 0.9% Bacteriostatic Local Anesthetic Injection; Procedure: Eyelid Lesion Removal

Study type: Interventional

Funder types: Other

Identifiers

NCT05294640

22-36276

Details and patient eligibility

About

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

Full 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 University of California, San Francisco. 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.

Enrollment: 95 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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95 participants in 2 patient groups

Bacteriostatic Saline as Local Anesthesia

Experimental group

Description:

Patients receiving bacteriostatic saline as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department

Treatment:

Procedure: Eyelid Lesion Removal

Drug: 0.9% Bacteriostatic Local Anesthetic Injection

Lidocaine with Epinephrine as Local Anesthesia

Active Comparator group

Description:

Patients receiving lidocaine with epinephrine as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department

Treatment:

Procedure: Eyelid Lesion Removal

Drug: 1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection