Flex Appeal: A Prospective Randomized Controlled Trial Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia (MUA)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Change in degrees of motion of the affected knee
研究概览
简要总结
The purpose of this study is to determine if changing the type of anesthesia improves the outcomes of manipulation and pain control after the procedure. The study will compare a spinal anesthesia with a general anesthesia, to see if there is a better outcome from either anesthesia type.
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
- Single (Outcomes Assessor)
盲法说明
Investigator and surgeon will be masked
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years presenting for a manipulation of knee joint under anesthesia.
- •ASA Classification I - III.
- •English speaking patients.
排除标准
- •Daily chronic opioid use (over 3 months of continuous opioid use).
- •Inability to communicate pain scores or need for analgesia.
- •Infection at the site of block placement
- •Age under 18 years old or greater than 75 years old
- •Pregnant women (as determined by point-of-care serum bHCG)
- •Intolerance/allergy to local anesthetics
- •Weight <50 kg
- •Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- •Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
- •Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.
- •BMI >50 kg/m
- •Allergy or contraindication to local anesthetics or any component of the multimodal analgesic regimen
- •(NSAIDs and acetaminophen)
- •Contraindication to spinal injection
研究组 & 干预措施
Spinal Anesthesia
Patients receive spinal anesthesia during MUA (manipulation under anesthesia).
干预措施: Spinal Anesthesia (Procedure)
Spinal Anesthesia
Patients receive spinal anesthesia during MUA (manipulation under anesthesia).
干预措施: Chloroprocaine (Drug)
General Anesthesia
Patients receive general anesthesia during MUA (manipulation under anesthesia).
干预措施: Propofol (Drug)
General Anesthesia
Patients receive general anesthesia during MUA (manipulation under anesthesia).
干预措施: General Anesthesia (Procedure)
结局指标
主要结局
Change in degrees of motion of the affected knee
时间窗: At time of procedure completion
次要结局
- Change in pain(Baseline, 24 hours, 48 hours, 72 hours post-procedure)
- Opioid use in PACU(Day 3)