Detecting Compartment Syndrome Pain in the Presence of Regional Anesthesia in Healthy Volunteers

Brigham and Women's Hospital1 个研究点分布在 1 个国家目标入组 42 人开始时间: 2020年9月29日最近更新: 2021年5月14日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Brigham and Women's Hospital
入组人数: 42
试验地点: 1
主要终点: Pressure-pain threshold and tolerance

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of the study is to determine how different types of Regional Anesthesia (nerve blocks) can be helpful to patients with lower extremity trauma who develop compartment syndrome (an increased pressure in the fascial compartments) which can occur after injury to the leg.

This is a prospective, randomized study in healthy volunteers, who will undergo testing of the leg using a cuff inflation system, involving quantitative sensory testing (QST), questionnaire completion, with ultrasound scanning and nerve blocks in a supervised, monitored setting (BWH Clinical Investigation Center).

Specific Aims

Determine the effect of adductor canal-saphenous nerve block (ACB) and popliteal-fossa nerve block (SNB-PF) vs no block on pressure and ischemic pain in a model of compartment syndrome.
Hypothesis: There will be minimal or no change in pressure pain threshold and tolerance and pain ratings with ACB alone
Hypothesis: There will be an increase in pressure pain threshold and tolerance and decrease in pain ratings with ACB plus popliteal-fossa nerve block (SNB-PF), compared to no block
Determine the concentration dependence of SNB-PF effect on pressure and ischemic pain by comparing increasing doses of local anesthetic.
Hypothesis: There will be a greater increase in pressure pain threshold and tolerance and great decrease in pain ratings with 1.5% mepivacaine than with 0.375% mepivacaine.

详细描述

Please complete the survey (copy and paste into new link). https://redcap.partners.org/redcap/surveys/?s=D4A4TN9TDL We will not contact you if the survey is incomplete.

Please contact us via email (ykchen@partners.org) about this study with subject line "Interested in participating in Compartment Syndrome Study"

Screening and Enrollment:

Healthy volunteers will be recruited, and all interested individuals will be invited to contact study staff to hear more about the study requirements and undergo a brief phone screen to determine eligibility. After their initial phone screen with study staff, interested subjects meeting eligibility requirements will be provided with an electronic copy of the consent form, perform a video consent, and schedule a study visit, to be conducted in the Clinical Investigation Center at Brigham and Women's Hospital. A 5 hour, 1 office visit is required.

All subjects will also undergo a survey-based COVID screen within 24 hours prior to the study.

研究设计

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

盲法说明

Participant will be masked to the drug being provided in the nerve blocks (0.375% mepivacaine or 1.5% mepivacaine)

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Age ≥ 18 years old, ≤ 65 years old
•Able to speak and understand English
•Willingness to undergo psychophysical testing
•Willingness to have nerve block performed

排除标准

•Ongoing acute or chronic pain in lower extremities
•Diagnosis of neuropathy
•Diagnosis of diabetes
•History of chronic opioid use (having an opioid prescription > 30 days)
•Loss of any limb
•Currently pregnant
•Any skin conditions or breakdown of skin affecting lower extremities
•Current history of peripheral arterial disease
•History of blood clot in any lower extremity
•Current smoking/vaping of nicotine or illicit substances including marijuana