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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Lesions That Needed Additional Anesthesia to Complete Procedure | Number of Lesions that Needed 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Kersten, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Francisco | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10216324 | Background | 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. | |
| 15728052 | 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. |
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95 patients with 110 lesions were recruited. There were 103 "encounters," creating duplicate patients in the two separate groups. The primary unit type analyzed was lesions. Participants had either 1, 2, or 3 lesions. Each lesion was randomized separately. Therefore, one participant could be part of both the bacteriostatic and lidocaine with epinephrine groups.
| ID | Title | Description |
|---|---|---|
| FG000 | Bacteriostatic Saline as Local Anesthesia | Patients receiving bacteriostatic saline as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department 0.9% Bacteriostatic Local Anesthetic Injection: 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. Eyelid Lesion Removal: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2024 |
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Patient and provider performing procedure will be masked to local anesthesia type
|
| 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. |
|
| 10 minutes |
| 10876451 | 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. |
| 8602315 | 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. |
| 32935453 | 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. |
| 15167724 | 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. |
| 35017698 | 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. |
| 10189646 | 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. |
| 8383150 | 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. |
| 25261140 | 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. |
| FG001 | Lidocaine With Epinephrine as Local Anesthesia | Patients receiving lidocaine with epinephrine as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department 1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection: 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: 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. |
| COMPLETED |
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| NOT COMPLETED |
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95 patients with 110 lesions were recruited. There were 103 "encounters," creating duplicate patients in the two separate groups. The primary unit type analyzed was lesions. Participants had either 1, 2, or 3 lesions. Each lesion was randomized separately. Therefore, one participant could be part of both the bacteriostatic and lidocaine with epinephrine groups.
| ID | Title | Description |
|---|---|---|
| BG000 | Bacteriostatic Saline as Local Anesthesia | Patients receiving bacteriostatic saline as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department 0.9% Bacteriostatic Local Anesthetic Injection: 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. Eyelid Lesion Removal: 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. |
| BG001 | Lidocaine With Epinephrine as Local Anesthesia | Patients receiving lidocaine with epinephrine as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department 1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection: 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: 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Lesions |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
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| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| |||||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
| ||||||||||||||||||||
| Baseline Lesion Size | Mean | Standard Deviation | Millimeters | Lesions |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Primary unit analyzed was lesions. Because each participant may have been randomized more than once, each participant may have more than one outcome. For this reason, outcome measures are expressed based on lesions rather than participants. | Posted | Mean | Standard Deviation | score on a scale | 5 minutes | Lesions | Lesions |
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| ||||||||||||||||||||||||||||
| 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. | Primary unit analyzed was lesions. Because each participant may have been randomized more than once, each participant may have more than one outcome. For this reason, outcome measures are expressed based on lesions rather than participants. | Posted | Mean | Standard Deviation | score on a scale | 10 minutes | Lesions | Lesions |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Lesions That Needed Additional Anesthesia to Complete Procedure | Number of Lesions that Needed Additional Anesthesia to Complete Procedure | Primary unit analyzed was lesions. Because each participant may have been randomized more than once, each participant may have more than one outcome. For this reason, outcome measures are expressed based on lesions rather than participants. | Posted | Number | lesions | 10 minutes | Lesions | Lesions |
| |||||||||||||||||||||||||||||||
| Secondary | Bleeding Level | Physician-assessed level of bleeding after procedure (mild, moderate, severe). These will be physician-reported verbally and recorded immediately after procedure. | Primary unit analyzed was lesions. Because each participant may have been randomized more than once, each participant may have more than one outcome. For this reason, outcome measures are expressed based on lesions rather than participants. | Posted | Number | Number of lesions | 10 minutes | Lesions | Lesions |
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Monitored for approximately 10 minutes following injection
At risk patients listed on patient, not procedure level
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bacteriostatic Saline as Local Anesthesia | Patients receiving bacteriostatic saline as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department 0.9% Bacteriostatic Local Anesthetic Injection: 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. Eyelid Lesion Removal: 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. | 0 | 55 | 0 | 55 | 0 | 55 |
| EG001 | Lidocaine With Epinephrine as Local Anesthesia | Patients receiving lidocaine with epinephrine as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department 1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection: 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: 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. | 0 | 48 | 0 | 48 | 0 | 48 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meleha Ahmad | Moyes Eye Center | 401-523-5911 | meleha.ahmad@gmail.com |
| Aug 29, 2024 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 6, 2022 | Jan 31, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005142 | Eyelid Neoplasms |
| D006726 | Hordeolum |
| ID | Term |
|---|---|
| D005153 | Facial Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005134 | Eye Neoplasms |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015817 | Eye Infections |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Lesions |
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| Lesions |
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| Lesions |
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| OG001 | Lidocaine With Epinephrine as Local Anesthesia | Patients receiving lidocaine with epinephrine as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department 1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection: 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: 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. |
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| OG001 | Lidocaine With Epinephrine as Local Anesthesia | Patients receiving lidocaine with epinephrine as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department 1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection: 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: 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. |
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| OG001 | Lidocaine With Epinephrine as Local Anesthesia | Patients receiving lidocaine with epinephrine as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department 1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection: 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: 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. |
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