Summary

Eligibility
for people ages 18-110 (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Robert Kersten
Headshot of Robert Kersten
Robert Kersten

Description

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

Details

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.

Keywords

Eyelid Tumor Eyelid Bump Eyelid Deformity Eyelid Abscess Eyelid Boil Eyelid Papilloma Anesthesia, Local Ophthalmology Oculoplastics Local Anesthesia Eyelid Anesthesia Periocular Anesthesia Papilloma Lidocaine Epinephrine Anesthetics, Local Anesthetics 0.9% Bacteriostatic Local Anesthetic Injection 1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection Eyelid Lesion Removal

Eligibility

You can join if…

Open to people ages 18-110

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

You CAN'T join if...

  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

Location

  • University of California at San Francisco
    San Francisco California 94158 United States

Lead Scientist at UCSF

  • Robert Kersten
    Professor, Ophthalmology, School of Medicine. Authored (or co-authored) 189 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05294640
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated