Understanding Rebound Pain After Regional Anesthesia Resolution: Mechanistic Trial in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Heat pain detection threshold at time 1 hr
研究概览
简要总结
Regional anesthesia decreases postoperative pain scores and opioid consumption, and may prevent chronic pain after surgery in patients undergoing surgery. However, some patients experience an increase of pain into the severe range when the nerve block wears off, also known as rebound pain. The investigators are studying if a nerve block (numbing injection) in the arm causes hyperalgesia (increased pain) when the nerve block is wearing off.
详细描述
This is a prospective, randomized study in healthy volunteers who will undergo sensory testing using quantitative sensory testing (QST), complete psychosocial and pain questionnaires, and ultrasound-guided peripheral nerve block of the arm (axillary nerve block) in a supervised, monitored setting (BWH Clinical Investigation Center). The investigators plan to assess the association between different QST modalities at different time points pre- and post-nerve block resolution. Semi-structured interviews and qualitative analysis will be used to explore patient's experiences with nerve block placement.
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
- None
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
- •BMI >18, < 35
- •Able to speak and understand English
- •Willingness to undergo psychophysical testing (e.g., QST, pain questionnaires)
- •Willingness to have nerve block performed
排除标准
- •Ongoing acute or chronic pain in upper extremities
- •Skin or tissue infection affecting upper extremities
- •Previous hypersensitivity to mepivacaine or lidocaine
- •Previous neuropathy (numbness, paresthesia, or motor weakness) in either upper extremity
- •Loss of any limb
- •Bleeding issues or bleeding disorder
- •History of alcohol or drug abuse
- •Currently pregnant or breastfeeding
- •History of seizure or epilepsy
研究组 & 干预措施
Block upper extremity (arm)
Upper extremity with a nerve block
干预措施: Mepivacaine (Drug)
结局指标
主要结局
Heat pain detection threshold at time 1 hr
时间窗: 1 hour after nerve block resolution
Heat pain detection threshold (°C) between block arm and control arm using a heat probe at 1 hour after nerve block resolution
次要结局
- Light touch detection(0-3 hours after nerve block resolution)
- Light touch pain threshold(0-3 hours after nerve block resolution)
- Heat pain detection threshold and tolerance(0-3 hours after nerve block resolution)
- Pressure pain threshold and tolerance(0-3 hours after nerve block resolution)
- Temporal summation and sharp pain(0-3 hours after nerve block resolution)
研究者
Yun-Yun K. Chen
Principal Investigator
Brigham and Women's Hospital