Efficacy of Injected Local Anesthetic vs Topical Anesthetic in Cosmetic Injectable Fillers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Participants Anesthetic Preference
研究概览
简要总结
The purpose of the study is to compare two modalities of local anesthetic administration prior to the placement of cosmetic facial injectable fillers. Both short and long term pain perceptions for the facial filler procedure will be compared in patients receiving 4% Topicaine gel on half their face, and 20% benzocaine gel prior to 2% lidocaine 1:100k epinephrine nerve block injections on the other half of their face. The objective is to quantify the subjective pain experienced by these two modalities of local anesthetic during the procedure of Juvederm XC filler injections.
详细描述
The purpose of this study is to determine if local anesthesia injections will provide more profound analgesia than topical anesthesia during facial cosmetic filler injections. The study is a single group study design. The attending surgeon or residents will perform the procedure. Each procedure will start with a randomized coin flip to determine which side of the face will be anesthetized with local anesthesia or topical anesthesia. The head side of the coin will coincide with local anesthesia on the patient's right side. The tail of the coin will designate the patient's left side for local anesthetic injections.
To evaluate whether the additional anesthesia of a nerve block brings more pain relief than the initial pain of receiving a nerve block, the pain value will be collected from each nerve block administered. Procedural injection pain data will be collected from the nerve blocked facial half and from the topical anesthetic facial half to provide a comparison of anesthesia during the procedure. The primary outcome will be the collection of "overall" pain data from each side of the face 5-10 minutes after the procedure. Facial anesthesia preference data will also be collected at one week post treatment to determine overall pain perceptions from each method of facial anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with deepened labiomental folds or decreased lip volume and architecture who are scheduled to receive Juvederm XC injections in DGMC Oral & Maxillofacial Surgery clinic.
排除标准
- •Pregnant or nursing
- •History of any type of neuralgia or paresthesia, or paresis
- •Allergy or contraindication to lidocaine or hyaluronic acid
- •Use of hyaluronic acid in last 6 months
- •Previous reaction to Juvederm or other hyaluronic acid based fillers
- •Have an active inflammatory or infectious process at the injection site.
- •Use of monoamine oxidase (MAO) inhibitors or tricyclic antidepressants
- •Severe coronary artery disease
- •Diagnosis of any cardiac dysrhythmia with an ECG finding other than normal sinus rhythm
研究组 & 干预措施
Injectable / Topical
Half of the face is injected with local anesthesia (lidocaine-epinephrine), the other half is treated with topical anesthesia (topicaine gel) per randomize method.
干预措施: Injectable (Drug)
Injectable / Topical
Half of the face is injected with local anesthesia (lidocaine-epinephrine), the other half is treated with topical anesthesia (topicaine gel) per randomize method.
干预措施: Topical (Drug)
结局指标
主要结局
Participants Anesthetic Preference
时间窗: one week post treatment
Patient will complete a questionnaire to evaluate his/her preference of anesthetic modality.
次要结局
- Mean Pain Level Associated With the Local Anesthetic Injection(5-10 minutes post-procedure)
- Mean Pain Level Associated With the Local Topical Anesthetic(5-10 min post procedure)
- Mean Pain Level Associated With Facial Filler Injection at the Upper Lip(5-10 minutes post procedure)
- Mean Pain Level Associated With Facial Filler Injection to the Lower Lip(5-10 minutes post procedure)
- Mean Pain Level Associated With Facial Filler Injection to the Nasolabial Fold(5-10 minutes post procedure)