Clinical trial NCT05294640: Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures
Official title: Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Eyelid Tumor
Eyelid Bump
Eyelid Deformity
Eyelid Abscess
Eyelid Boil
Eyelid Papilloma
Anesthesia, Local
Ophthalmology
Keywords: Oculoplastics
Local Anesthesia
Eyelid Anesthesia
Periocular Anesthesia
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain on injection
timeFrame: 5 minutes
measure: Pain of procedure
timeFrame: 10 minutes
Secondary outcomes:
measure: Additional Anesthesia
timeFrame: 10 minutes
measure: Bleeding level
timeFrame: 10 minutes
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Robert Kersten, MD
role: PRINCIPAL_INVESTIGATOR
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