Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures
Phase: PHASE4
Conditions: Eyelid Tumor, Eyelid Bump, Eyelid Deformity, Eyelid Abscess, Eyelid Boil, Eyelid Papilloma, Anesthesia, Local, Ophthalmology
Sponsor: University of California, San Francisco

NCT05294640  
2/3/2024 
 
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Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures  
 
Introduction  
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 lidocaine1, while maintaining adequate pain relief for certain procedures 
such as IV insertion2,3, cervical anesthesia4 and hip injections5. It has also been 
demonstrated to provide pain relief when used to reconstitute botulinum toxin and to 
have greater cost effectiveness compared to lidocaine10,6.  
 
The use of bacteriostatic saline alone as an anesthetic for incisional procedures in the 
periocular area has not yet been studied.7 In a prospective, randomized, double-blinded 
randomized control trial comparing lidocaine buffered with either bacteriostatic saline or 
sodium bicarbonate in incisional eyelid surgery, lidocaine buffered with bacteriostatic 
saline showed greater comfort on injection with bacteriostatic saline buffer while 
providing a similar level of anesthesia,8 bacteriostatic saline with epinephrine was 
significantly less painful on infiltration. In a dermatologic randomized controlled trial, 
compared to lidocaine buffered with sodium bicarbonate for superficial procedures such 
as shave excision, scissor excision, superficial curettage but not deep punch biopsy or 
flap closures.9 
 
Clinical question  
 
Does bacteriostatic saline an adequate level of anesthesia compared to lidocaine with 
epinephrine while reducing pain associated with medication infusion in minor eyelid 
procedures.  
 
Participants  
 
Patients >= 18 years old undergoing clinic-based “minor” eyelid procedures in clinic with 
at least one lesion.  
 
Inclusion criteria:  
1. Age >=18 years old  
2. Any eyelid lesion presenting to clinic setting  
Exclusion criteria  
1. Any other topical, PO or IV sedating medications given alongside procedure  
2. Allergy to lidocaine or epinephrine  
 
Intervention 
  
1. 0.9% Bacteriostatic Saline  
2. 2% Lidocaine + 1/100,000 Epinephrine  
 
Outcome Measures  

NCT05294640  
2/3/2024 
 
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Primary 
1. Pain during injection (1-10) 
2. Pain during procedure (1-10)  
 
Secondary 
1. Bleeding requiring >5 minutes of firm pressure or cautery  
2. Need for additional anesthesia  
 
Study Protocol  
 
Prior to clinic day, patient list will be reviewed to identify potentially eligible patients. On 
the procedure day, eligible patients will be approached for participation following initial 
evaluation by attending physician. If patient amenable, patient will be consented for 
study. Photograph will be taken of the lesion directly in electronic medical record, and 
lesion circled using annotate function. Each lesion will be randomized separately using 
iPhone-based randomization application to either bacteriostatic saline or lidocaine with 
epinephrine. Fellow will be unblinded, attending physician blinded. Medication will be 
drawn up by fellow and handed to attending physician who will inject the medication. 
Immediately following injection, patient will be asked pain level on 0 to 10 scale, which 
was noted. Five minutes will be allowed to pass and then procedure will be 
commenced. If patient has more pain than acceptable to them, additional study agent 
will be injected and procedure re-started. If continued presence of pain, one more 
additional trial of the study agent will be allowed. If patient continues to have pain, 
medication will be defaulted to standard of care (lidocaine with epinephrine). 
Alternatively, if patient requests standard of care at any point, medication will be 
switched to this. Immediately following procedure, patient will be asked pain level on 0 
to 10 scale, which was noted. Number of reinjections or need to default to standard of 
care will be noted. Bleeding level (Mild, moderate, or severe) will be noted. Mild is 
defined as not needing pressure to stop. Moderate is defined as needing five minutes or 
pressure to stop. Severe is defined as needing cautery or a pressure patch. 
Immediately following injection, patient will be asked pain level on 0 to 10 scale.  
 
Statistical Plan  
 
Pain of injection and pain of procedure are recorded on a categorical scale and 
compared using Student T-Tests. Percent of lesions requiring reinjection and 
percentage of lesions with “severe” bleeding were compared using Chi-square tests. To 
see if lesions size had any effect on these metrics, the lesions will be divided into < 1 
mm, 1-5 mm, and > 5 mm, and analysis will be repeated on these groups.  
 
References  
 
1. Wilson L, Martin S. Benzyl alcohol as an alternative local anesthetic. Ann Emerg 
Med. 1999;33(5):495-499. doi:10.1016/s0196-0644(99)70335-5  

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2. Minogue SC, Sun DA. Bacteriostatic saline containing benzyl alcohol decreases the 
pain associated with the injection of propofol. Anesth Analg. 2005;100(3):683-686. 
doi:10.1213/01.ANE.0000148617.98716.EB  
 
3. Patterson P, Hussa AA, Fedele KA, Vegh GL, Hackman CM. Comparison of 4 
analgesic agents for venipuncture. AANA J. 2000;68(1):43-51.  
 
4. Miller L, Jensen MP, Stenchever MA. A double-blind randomized comparison of 
lidocaine and saline for cervical anesthesia. Obstet Gynecol. 1996;87(4):600-604. 
doi:10.1016/0029-7844(95)00463-7  
 
5. 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;13(8):811-818. 
doi:10.1002/pmrj.12489  
 
6. Kwiat DM, Bersani TA, Bersani A. Increased patient comfort utilizing botulinum toxin 
type a reconstituted with preserved versus nonpreserved saline. Ophthal Plast Reconstr 
Surg. 2004;20(3):186-189. doi:10.1097/01.iop.0000129012.09632.49  
 
7. Hunt SV, Malhotra R. Bacteriostatic preserved saline for pain-free periocular 
injections: review. Eye Lond Engl. Published online January 11, 2022. 
doi:10.1038/s41433-021-01925-z  
 
8. Yuen VH, Dolman PJ. Comparison of three modified lidocaine solutions for use in 
eyelid anesthesia. Ophthal Plast Reconstr Surg. 1999;15(2):143-147. 
doi:10.1097/00002341-199903000-00017  
 
9. Lugo-Janer G, Padial M, Sánchez JL. Less painful alternatives for local anesthesia. J 
Dermatol Surg Oncol. 1993;19(3):237-240. doi:10.1111/j.1524-4725.1993.tb00342.x  
 
10. OmanKS,FinkR,KleinerC,etal.IntradermalLidocaineorBacteriostaticNormal Saline to 
Decrease Pain Before Intravenous Catheter Insertion: A Meta-Analysis. J Perianesth 
Nurs. 2014;29(5):367-376. doi:10.1016/j.jopan.2013.12.008