- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05294640
Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures
December 22, 2023 updated by: University of California, San Francisco
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
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
95
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Meleha T Ahmad
- Phone Number: 401-523-5911
- Email: meleha.ahmad@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94158
- University of California at San Francisco
-
Contact:
- Meleha Ahmad, MD
- Phone Number: 401-523-5911
- Email: meleha.ahmad@ucsf.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 110 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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.
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.
|
Active Comparator: 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
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain on injection
Time Frame: 5 minutes
|
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
Time Frame: 10 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Additional Anesthesia
Time Frame: 10 minutes
|
Need for additional anesthesia to complete procedure
|
10 minutes
|
Bleeding level
Time Frame: 10 minutes
|
Physician-assessed level of bleeding after procedure (mild, moderate, severe).
These will be physician-reported verbally and recorded immediately after procedure.
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robert Kersten, MD, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 17, 2022
Primary Completion (Actual)
February 21, 2023
Study Completion (Actual)
February 21, 2023
Study Registration Dates
First Submitted
March 8, 2022
First Submitted That Met QC Criteria
March 23, 2022
First Posted (Actual)
March 24, 2022
Study Record Updates
Last Update Posted (Actual)
December 29, 2023
Last Update Submitted That Met QC Criteria
December 22, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Neoplasms, Squamous Cell
- Papilloma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Membrane Transport Modulators
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Anesthetics
- Lidocaine
- Anesthetics, Local
- Epinephrine
Other Study ID Numbers
- 22-36276
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anesthesia, Local
-
Grünenthal GmbHTerminatedAnalgesia | Anesthesia, Local | AnesthesiaNetherlands
-
Assistance Publique - Hôpitaux de ParisINSERM UMR-942, Paris, France; M3DISIMNot yet recruitingPrediction Models for Cardiovascular and Neurocognitive Disease Risk in the General Population (CME)Anesthesia, Local | AnesthesiaFrance
-
Charite University, Berlin, GermanyCompletedAnesthesia, Local | AnesthesiaGermany
-
Charite University, Berlin, GermanyCompletedAnesthesia, Local | Anesthesia | Anesthesia; Adverse EffectGermany
-
Assistance Publique - Hôpitaux de ParisINSERM UMR-942, Paris, France; M3DISIMRecruiting
-
Novocol Pharmaceutical of Canada, Inc.CompletedAnesthesia, Local | Dental Anesthesia | Anesthesia, ReversalUnited States
-
University Health Network, TorontoRecruiting
-
Kfir SiagNot yet recruiting
-
Hams Hamed AbdelrahmanCompleted
-
University of BaghdadActive, not recruiting
Clinical Trials on 0.9% Bacteriostatic Local Anesthetic Injection
-
Jeffrey Alan Klein, MDNot yet recruitingAnesthesia, Local | Injection Site Irritation | Injection Site Discomfort | Injection Site Bruising | Benzoic Acid Adverse ReactionUnited States
-
Wake Forest University Health SciencesRecruitingChronic Plantar FasciitisUnited States
-
Hôpital du ValaisUniversity of Lausanne HospitalsCompleted
-
University Health Network, TorontoRecruiting
-
PATHCenters for Disease Control and Prevention; Institut de Recherche pour le DeveloppementCompleted
-
Virginia Commonwealth UniversityTerminatedRib FracturesUnited States
-
Mustafa Kemal UniversityRecruitingEfficacy of Dextrose Prolotherapy in Myofascial Pain SyndromeTurkey
-
Lithuanian University of Health SciencesUnknownPrimary Total Knee ArthroplastyLithuania
-
Aretaieion University HospitalKAT General HospitalActive, not recruitingPain, Postoperative | Analgesia | Pain, Acute | Ketamine | Pain, Chronic | Morphine | Pain, NeuropathicGreece
-
Livzon Pharmaceutical Group Inc.UnknownCarcinogenic FatigueChina