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NCT Number: NCT05294640

Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures

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

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Key information

Conditions

Eyelid Tumor Anesthesia, Local Bacterial Infections Bacterial Infections and Mycoses Eye Diseases Eye Infections Eye Infections, Bacterial Eye Neoplasms Eyelid Abscess Eyelid Boil Eyelid Bump Eyelid Deformity Eyelid Diseases Eyelid Neoplasms Eyelid Papilloma Facial Neoplasms Head and Neck Neoplasms Hordeolum Infections Neoplasms Neoplasms by Site Ophthalmology

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California at San Francisco

San Francisco, California, 94158, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.9% Bacteriostatic Local Anesthetic Injection

Drug

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.

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

Drug

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.

Eyelid Lesion Removal

Procedure

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.

Primary outcomes

  1. Pain on Injection

    Time frame: 5 minutes

    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.

  2. Pain of Procedure

    Time frame: 10 minutes

    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.

Secondary outcomes

  1. Number of Lesions That Needed Additional Anesthesia to Complete Procedure

    Time frame: 10 minutes

    Number of Lesions that Needed Additional Anesthesia to Complete Procedure

  2. Bleeding Level

    Time frame: 10 minutes

    Physician-assessed level of bleeding after procedure (mild, moderate, severe). These will be physician-reported verbally and recorded immediately after procedure.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2022
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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