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临床试验/NCT03595449
NCT03595449已完成4 期

Patient Satisfaction in Mohs Micrographic Surgery With Supplemental Lidocaine Jelly

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 233 人开始时间: 2018年8月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
Mayo Clinic
入组人数
233
试验地点
1
主要终点
Mean Change in Patient Perception of Pain Score

研究概览

简要总结

Does the use of lidocaine jelly during Mohs surgery on the nose decrease the total amount of lidocaine used during surgery.

Does patient satisfaction improve when lidocaine jelly is used during Mohs surgery of the nose?

详细描述

Hypothesis: Supplementing lidocaine/epinephrine injections with intralesional lidocaine jelly will decrease the overall quantity of lidocaine/epinephrine injectable used, and will decrease patients' self-reported pain/anxiety associated with needle sticks.

Objectives: To assess how using lidocaine jelly in Mohs surgery impacts 1) the overall quantity of lidocaine/epinephrine injectable needed to maintain anesthesia, and 2) patients' pain/anxiety associated with anesthesia injections.

Background:

Mohs micrographic surgery is a procedure that removes cancerous lesions of the skin in a step-wise fashion. Patients are injected with local analgesia for tumor extirpation. The tumor is removed and the tissue is sent for histopathology while the patient waits. Tissue processing time can take up to 2 hours during which the effects of the local analgesia have waned. Once the tissue has been process and examined, patients are brought back to the surgical suite and either have another section of tissue removed (if the margins were positive) or have the wound reconstructed (if the margins were negative). Lidocaine Hydrochloride (Xylocaine) injection with Epinephrine is the traditionally method used to maintain local anesthesia throughout the procedure. The FDA has declared a shortage of this injectable Lidocaine/Epinephrine, stressing the need for a substitute drug. Additionally, multiple needle sticks can be uncomfortable and anxiety provoking for patients. Needle sticks on hypersensitive areas such as the nose can be particularly painful. Previous research has demonstrated that a different form of anesthetic, a topical lidocaine jelly, is efficient in prolonging anesthesia in Mohs surgery (Robins, 1991). No study has published the impact of supplemental lidocaine jelly use on the overall quantity of injection needed, nor on patient pain/anxiety associated with needle sticks.

Methods:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Lidocaine jelly

Active Comparator

This is the group that will have lidocaine jelly applied during Mohs surgery

干预措施: Lidocaine jelly (Drug)

Surgilube

Sham Comparator

This is the group that will have surgilube (placebo) applied during Mohs surgery

干预措施: Surgilube (Drug)

结局指标

主要结局

Mean Change in Patient Perception of Pain Score

时间窗: baseline to stage 1 of Mohs surgery, approximately one hour

The mean change of total pain score of patient perception of pain. As measured by the question "Rate the pain of your nose from 0 to 10. 0 being no pain, 10 being the worst pain of your life."

次要结局

  • Mean Total Amount of Intervention (Lidocaine or Surgilube) Used(Through completion of Mohs surgery, approximately one day)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shari Ochoa MD

Assistant Professor

Mayo Clinic

研究点 (1)

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