Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures
NCT05294640 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 95
Last updated 2025-07-08
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
Conditions
- Eyelid Tumor
- Eyelid Bump
- Eyelid Deformity
- Eyelid Abscess
- Eyelid Boil
- Eyelid Papilloma
- Anesthesia, Local
- Ophthalmology
Interventions
- DRUG
-
0.9% Bacteriostatic Local Anesthetic Injection
Following research and procedural consent, local anesthetic injection will be carried out using a standard 1 cc of local anesthetic corresponding to the study arm (0.9% bacteriostatic saline or 1% lidocaine with 1:100,000 epinephrine). Prior to anesthetic administration, the procedure site will be cleaned using standard measures. A 30 gauge needle on a 3 centimeter cubed volume syringe will be utilized. Five minutes will be given for local anesthetic to take effect.
- DRUG
-
1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection
Following research and procedural consent, local anesthetic injection will be carried out using a standard 1 cc of local anesthetic consisting of a commercially available mixture of 1% lidocaine with 1:100,000 epinephrine. Prior to anesthetic administration, the procedure site will be cleaned using standard measures. A 30 gauge needle on a 3 centimeter cubed volume syringe will be utilized. Five minutes will be given for local anesthetic to take effect.
- PROCEDURE
-
Eyelid Lesion Removal
Following anesthesia administration, patient will proceed with recommended eyelid lesion removal. The procedure site will be cleaned according to standard protocol, and standard technique for lesion removal will be performed, which will vary according to type of lesion but may involve use of Westcott scissors, forceps, #15 or #11 blades or other oculoplastics administration. The exact procedural details will be at the discretion of the surgeon.
Sponsors & Collaborators
-
University of California, San Francisco
lead OTHER
Principal Investigators
-
Robert Kersten, MD · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 110 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-17
- Primary Completion
- 2023-02-21
- Completion
- 2023-02-21
- FDA Drug
- Yes
Countries
- United States
Study Locations
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