Locally Administered Bupivacaine Hydrochloride for Post-operative Pain Control in Cutaneous Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reported opioid and non-opioid pain medications taken
研究概览
简要总结
The purpose of this study is to determine if the addition of bupivacaine HCl injections will improve pain control after skin surgery.
This is a randomized clinical trial. Approximately 100 participants will be randomized to receive either bupivacaine HCl or saline injections to help with the postsurgical pain. Patients will be provided with a take-home journal to complete indicating when and how much pain medication they required for the 3 days immediately following surgery. Participants will return the journal in-person at a follow up visit 7-21 days post-op. This study was a pilot study designed to determine the feasibility of this procedure.
Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be invited and considered for enrollment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>18 years of age
- •Receiving cutaneous surgery
- •In good general health as assessed by the investigator
排除标准
- •Participants with an allergy to bupivacaine or other amide anesthetics
- •Participants unwilling to sign an IRB approved consent form
- •Participants with a contraindication to narcotic medication
- •Participants who are pregnant or will become pregnant
- •Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible
研究组 & 干预措施
Saline
Immediately prior to surgical wound closure, participants randomized to saline, will receive saline injections along the closure site.
干预措施: Saline (Drug)
Bupivacaine HCl
Immediately prior to surgical wound closure, participants randomized to the bupivacaine arm will be injected with bupivacaine HCl along the closure site.
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Reported opioid and non-opioid pain medications taken
时间窗: 3 Days Post-Surgery
Patients will report the amount of pain medications taken 3 days immediately following surgery
次要结局
未报告次要终点
研究者
Murad Alam
Professor of Dermatology
Northwestern University