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临床试验/NCT05294640
NCT05294640已完成4 期

Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2022年5月17日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
95
试验地点
1
主要终点
Pain on Injection

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

Patient and provider performing procedure will be masked to local anesthesia type

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >=18 years old
  • Undergoing clinic-based periocular procedure

排除标准

  • 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

研究组 & 干预措施

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

干预措施: 0.9% Bacteriostatic Local Anesthetic Injection (Drug)

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

干预措施: Eyelid Lesion Removal (Procedure)

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

干预措施: Eyelid Lesion Removal (Procedure)

结局指标

主要结局

Pain on Injection

时间窗: 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.

Pain of Procedure

时间窗: 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.

次要结局

  • Number of Lesions That Needed Additional Anesthesia to Complete Procedure(10 minutes)
  • Bleeding Level(10 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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