Anesthesia, Local Clinical Trial
Official title:
Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures
Verified date | December 2023 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 95 |
Est. completion date | February 21, 2023 |
Est. primary completion date | February 21, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 110 Years |
Eligibility | Inclusion Criteria: 1. Age >=18 years old 2. Undergoing clinic-based periocular procedure Exclusion Criteria: 1. Any other topical, oral or intravenous sedating medications given alongside procedure 2. Allergy to saline, lidocaine or epinephrine 3. Unable to provide consent due to cognitive impairment |
Country | Name | City | State |
---|---|---|---|
United States | University of California at San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Erratum In: J Perianesth Nurs. 2015 Feb;30(1):85. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Additional Anesthesia | Need for additional anesthesia to complete procedure | 10 minutes | |
Secondary | 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 |
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