NCT07485803招募中4 期
A Prospective, Randomized Trial Utilizing Methadone in the Management of Post-Operative Pain in Total Knee Replacement
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- AdventHealth
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Opioid use for 48 hours post-operatively
研究概览
简要总结
The goal of this study is to determine whether one dose of IV methadone given right before surgery will help patients' pain management after a total knee replacement and reduce the amount of pain medications taken in the weeks after surgery.
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
- Double (Participant, Investigator)
盲法说明
Research staff
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent from
- •Stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study.
- •Unilateral total knee arthroplasty at Colorado Joint Replacement
- •All individuals will be screened for drug use (opioid use, illicit drug use) at their preoperative appointment
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
排除标准
- •Narcotic use in the past 6 weeks
- •Current or previous history of drug and alcohol abuse
- •Tobacco use in the previous 90 days
- •Treatment with another investigational drug
- •Patients that cannot receive spinal anesthesia
- •Patients that cannot receive the standardized multimodal pain medications (i.e. Tylenol, gabapentin and meloxicam)'
- •Patients that are not able to go home after leaving the hospital and require a short-term rehabilitation facility
- •Obstructive sleep apnea
- •Morbid obesity (BMI >40)
- •Patients with liver disease.
- •Significant kidney disease - stage 3 CKD or greater
- •Pregnant or nursing females
- •Baseline QTc >480
- •severe COPD (GOLD 3 or 4)
- •home oxygen requirement
研究组 & 干预措施
No medication
No Intervention
Patient will receive only the standard of care medications for their procedure.
Methadone
Experimental
Patient will receive one perioperative dose of IV methadone prior to their surgical procedure in addition to standard of care medications.
干预措施: Methadone (Drug)
结局指标
主要结局
Opioid use for 48 hours post-operatively
时间窗: 48 hours after TKA procedure
Opioid use will be calculated using morphine milligram equivalents (MME). Patients will keep a log to track opioid consumption.
次要结局
- Defense and Veterans Pain Scale(2 weeks after TKA procedure)
- Opioid-Related Symptom Distress Scale (ORSDS)(At baseline and 2 weeks after TKA procedure)
- Pittsburgh Sleep Quality Index(At baseline and 2 weeks after TKA procedure)
- Knee Society Score(At baseline)
- KOOS-12 Knee Survey(At baseline)
- Veterans Rand 12-Item Health Survey (VR-12)(At baseline)
- Opioid-Related Symptom Distress Scale (ORSDS)(2 weeks after TKA procedure)
- Pittsburgh Sleep Quality Index(2 weeks after TKA procedure)
- Total opioid usage over 2 weeks post-operatively(2 weeks after TKA procedure)
- Knee Society Score(2 weeks after TKA procedure)
- KOOS-12 Knee Survey(2 weeks after TKA procedure)
- Veterans Rand 12-Item Health Survey (VR-12)(2 weeks after TKA procedure)
研究者
研究点 (1)
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