Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures

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

Intervention / Treatment
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* Drug: 0.9% Bacteriostatic Local Anesthetic Injection
* Drug: 1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection
* Procedure: Eyelid Lesion Removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >=18 years old Undergoing clinic-based periocular procedure Exclusion Criteria: Any other topical, oral or intravenous sedating medications given alongside procedure Allergy to saline, lidocaine or epinephrine Unable to provide consent due to cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bacteriostatic Saline as Local Anesthesia<br>Patients receiving bacteriostatic saline as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department | Drug: 0.9% Bacteriostatic Local Anesthetic Injection<br>* 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.<br>Procedure: Eyelid Lesion Removal<br>* 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.<br>|
| Active Comparator: Lidocaine with Epinephrine as Local Anesthesia<br>Patients receiving lidocaine with epinephrine as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department | Drug: 1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection<br>* 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.<br>Procedure: Eyelid Lesion Removal<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on injection | 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. | 5 minutes | 
| Pain of procedure | 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. | 10 minutes | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oculoplastics, Local Anesthesia, Eyelid Anesthesia, Periocular Anesthesia