Wrist Reduction Intervention: Supracondylar Technique for Radial Nerve Block vs. Hematoma Block (WRIST Block Study)
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Pain levels comparison
研究概览
简要总结
The purpose of this study is to compare different types of local anesthesia-a supracondylar radial nerve block, a hematoma block, or a combination of the two-for reducing pain in people with a broken wrist (distal radius fracture). This is being done to find out which method provides better pain relief after the injury and during treatment in the emergency room.
详细描述
This study is testing different ways to provide pain relief before reducing a broken wrist. Participants will receive one of three techniques: (1) a nerve block where a doctor injects lidocaine near the radial nerve under ultrasound guidance; (2) a hematoma block where a doctor injects lidocaine into the area where the bone broke; or (3) both the nerve block and the hematoma block. Patients will be asked how much pain they feel before the numbing, after the numbing, and after the wrist is reduced.
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
- 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
- 否
入选标准
- •18 years of age or older
- •Patients admitted to the ECC with a distal radius fracture requiring closed reduction
- •Patient must be willing and able to provide informed consent to the study
排除标准
- •Under 18 years of age
- •Allergy to lidocaine
- •Patients unable to provide informed consent and/or perform study-related activities
- •Patients undergoing procedural sedation
- •Patients may be excluded at the discretion of the investigator based on their clinical judgment, if the participant no longer meets criteria, and/or if the health or safety of the patient may be impacted by taking part in the study.
结局指标
主要结局
Pain levels comparison
时间窗: Pain will be measured at (1) baseline, (2) after administering the assigned pain block(s), and after the (3) fracture reduction.
Comparing pain levels among patients who are undergoing a wrist fracture reduction. Measured on a scale of 0-10, 0= no pain to 10= worst pain. Pain will be measured at (1) baseline, (2) after administering the assigned pain block (s), and after the (3) fracture reduction.
次要结局
- Amount of opioid medication needed to control pain.(Opioid medication prescribing will be assessed at baseline, time of admission to the emergency room, until the patient is discharged and they are no longer active in the study.)
- Number of patients requiring conscious sedation.(Patients will be monitored for need of conscious sedation from baseline, time of enrollment in the study, until discharge from the emergency room, when they are no longer active in the study.)
- Adverse Events Monitoring(From baseline, time the patient is admitted and enrolled into the study, until the patient is discharged and no longer active in the study.)
研究者
Aaron Grossberg
Principal Investigator
Sarasota Memorial Health Care System