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Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures

Primary Purpose

Eyelid Tumor, Eyelid Bump, Eyelid Deformity

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
0.9% Bacteriostatic Local Anesthetic Injection
1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection
Eyelid Lesion Removal
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eyelid Tumor focused on measuring Oculoplastics, Local Anesthesia, Eyelid Anesthesia, Periocular Anesthesia

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California at San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bacteriostatic Saline as Local Anesthesia

Lidocaine with Epinephrine as Local Anesthesia

Arm Description

Patients receiving bacteriostatic saline as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department

Patients receiving lidocaine with epinephrine as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Additional Anesthesia
Need for additional anesthesia to complete procedure
Bleeding level
Physician-assessed level of bleeding after procedure (mild, moderate, severe). These will be physician-reported verbally and recorded immediately after procedure.

Full Information

First Posted
March 8, 2022
Last Updated
March 23, 2022
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05294640
Brief Title
Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures
Official Title
Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
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 UCSF. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelid Tumor, Eyelid Bump, Eyelid Deformity, Eyelid Abscess, Eyelid Boil, Eyelid Papilloma, Anesthesia, Local, Ophthalmology
Keywords
Oculoplastics, Local Anesthesia, Eyelid Anesthesia, Periocular Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Patient and provider performing procedure will be masked to local anesthesia type
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bacteriostatic Saline as Local Anesthesia
Arm Type
Experimental
Arm Description
Patients receiving bacteriostatic saline as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department
Arm Title
Lidocaine with Epinephrine as Local Anesthesia
Arm Type
Active Comparator
Arm Description
Patients receiving lidocaine with epinephrine as local anesthesia for in-office minor eyelid procedures at University of California, San Francisco Medical Center, Oculoplastics department
Intervention Type
Drug
Intervention Name(s)
0.9% Bacteriostatic Local Anesthetic Injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
1% Lidocaine with 1:100,000 epinephrine Local Anesthetic Injection
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Eyelid Lesion Removal
Intervention Description
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 Outcome Measure Information:
Title
Pain on injection
Description
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.
Time Frame
5 minutes
Title
Pain of procedure
Description
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.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Additional Anesthesia
Description
Need for additional anesthesia to complete procedure
Time Frame
10 minutes
Title
Bleeding level
Description
Physician-assessed level of bleeding after procedure (mild, moderate, severe). These will be physician-reported verbally and recorded immediately after procedure.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meleha T Ahmad
Phone
401-523-5911
Email
meleha.ahmad@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Kersten, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meleha Ahmad, MD
Phone
401-523-5911
Email
meleha.ahmad@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10216324
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.
Results Reference
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PubMed Identifier
15728052
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.
Results Reference
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PubMed Identifier
10876451
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.
Results Reference
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PubMed Identifier
8602315
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.
Results Reference
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PubMed Identifier
32935453
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.
Results Reference
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PubMed Identifier
15167724
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.
Results Reference
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PubMed Identifier
35017698
Citation
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.
Results Reference
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PubMed Identifier
10189646
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.
Results Reference
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PubMed Identifier
8383150
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.
Results Reference
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PubMed Identifier
25261140
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.
Results Reference
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Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures

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