Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures

NCT05294640 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 22-36276
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Oculoplastics; Local Anesthesia; Eyelid Anesthesia; Periocular Anesthesia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Number of Lesions That Needed Additional Anesthesia to Complete Procedure

  10 minutes

• Bleeding Level

  10 minutes

Study Arms (2)

Bacteriostatic Saline as Local Anesthesia

EXPERIMENTAL

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; Procedure: Eyelid Lesion Removal

Lidocaine with Epinephrine as Local Anesthesia

ACTIVE COMPARATOR

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; Procedure: Eyelid Lesion Removal

Interventions

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.

Bacteriostatic Saline as Local Anesthesia

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.

Lidocaine with Epinephrine as Local Anesthesia

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.

Bacteriostatic Saline as Local Anesthesia; Lidocaine with Epinephrine as Local Anesthesia

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=18 years old
• Undergoing clinic-based periocular procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California at San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (10)

• Wilson L, Martin S. Benzyl alcohol as an alternative local anesthetic. Ann Emerg Med. 1999 May;33(5):495-9. doi: 10.1016/s0196-0644(99)70335-5.

  PMID: 10216324 BACKGROUND

• Minogue SC, Sun DA. Bacteriostatic saline containing benzyl alcohol decreases the pain associated with the injection of propofol. Anesth Analg. 2005 Mar;100(3):683-686. doi: 10.1213/01.ANE.0000148617.98716.EB.

  PMID: 15728052 BACKGROUND

• Patterson P, Hussa AA, Fedele KA, Vegh GL, Hackman CM. Comparison of 4 analgesic agents for venipuncture. AANA J. 2000 Feb;68(1):43-51.

  PMID: 10876451 BACKGROUND

• Miller L, Jensen MP, Stenchever MA. A double-blind randomized comparison of lidocaine and saline for cervical anesthesia. Obstet Gynecol. 1996 Apr;87(4):600-4. doi: 10.1016/0029-7844(95)00463-7.

  PMID: 8602315 BACKGROUND

• Kruse RC, Kindle BJ, Wisniewski S, Presley J, Smith J, Sellon JL. Local Anesthesia Prior to Ultrasound-Guided Hip Joint Injections: A Double-Blind Randomized Controlled Trial of Bacteriostatic Saline versus Buffered Lidocaine. PM R. 2021 Aug;13(8):811-818. doi: 10.1002/pmrj.12489. Epub 2020 Nov 23.

  PMID: 32935453 BACKGROUND

• Kwiat DM, Bersani TA, Bersani A. Increased patient comfort utilizing botulinum toxin type a reconstituted with preserved versus nonpreserved saline. Ophthalmic Plast Reconstr Surg. 2004 May;20(3):186-9. doi: 10.1097/01.iop.0000129012.09632.49.

  PMID: 15167724 BACKGROUND

• Hunt SV, Malhotra R. Bacteriostatic preserved saline for pain-free periocular injections: review. Eye (Lond). 2022 Aug;36(8):1546-1552. doi: 10.1038/s41433-021-01925-z. Epub 2022 Jan 11.

  PMID: 35017698 BACKGROUND

• Yuen VH, Dolman PJ. Comparison of three modified lidocaine solutions for use in eyelid anesthesia. Ophthalmic Plast Reconstr Surg. 1999 Mar;15(2):143-7. doi: 10.1097/00002341-199903000-00017.

  PMID: 10189646 BACKGROUND

• Lugo-Janer G, Padial M, Sanchez JL. Less painful alternatives for local anesthesia. J Dermatol Surg Oncol. 1993 Mar;19(3):237-40. doi: 10.1111/j.1524-4725.1993.tb00342.x.

  PMID: 8383150 BACKGROUND

• Oman KS, Fink R, Kleiner C, Makic MB, Wenger B, Hoffecker L, Mancuso M, Schmiege S, Cook P. Intradermal lidocaine or bacteriostatic normal saline to decrease pain before intravenous catheter insertion: a meta-analysis. J Perianesth Nurs. 2014 Oct;29(5):367-76. doi: 10.1016/j.jopan.2013.12.008.

  PMID: 25261140 BACKGROUND

MeSH Terms

Conditions

Eyelid Neoplasms; Hordeolum

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Facial Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Eye Neoplasms; Eye Diseases; Eyelid Diseases; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Meleha Ahmad
• Organization: Moyes Eye Center

meleha.ahmad@gmail.com

401-523-5911

Study Officials

• Robert Kersten, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patient and provider performing procedure will be masked to local anesthesia type
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 24, 2022
• Study Start: May 17, 2022
• Primary Completion: February 21, 2023
• Study Completion: February 21, 2023
• Last Updated: July 8, 2025
• Results First Posted: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)