IV Meloxicam for Pain Management Post TJA: Prospective Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- Pain Measured by the Numeric Rating Scale
研究概览
简要总结
The purpose of this project is to determine if a change in patient reported pain, nausea and vomiting after total knee and hip arthroplasty could be observed with the substitution of Intravenous meloxicam for ketorolac in the current established peri-operative pain protocol and if these changes lead to a decrease in opioid consumption (in morphine equivalents).
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients over the age of 18,
- •Patients undergoing primary total knee or primary total hip replacement at the University of Miami Hospital,
- •Patients that have capacity to provide medical consent
排除标准
- •All patients under the age of 18
- •Prisoners, diabetics, increased risk of bleeding, and pregnant women.
- •Patients with prior surgery or history of infection on the joint of interest.
- •Patients with an estimated glomerular filtration rate (eGFR) <50 ml/min
- •Patients on dialysis or renal transplant.
- •Patients on steroid preoperatively.
- •Allergy to sulfas
- •Inability to provide medical consent.
- •Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements will exclude the participant.
研究组 & 干预措施
Ketorolac group
Participants will receive the institution specific joint replacement pain protocol, including ketorolac.
干预措施: Ketorolac (Drug)
IV meloxicam group
Participants will receive the institution specific joint replacement pain protocol, however with IV meloxicam substituted for ketorolac.
干预措施: IV meloxicam (Drug)
结局指标
主要结局
Pain Measured by the Numeric Rating Scale
时间窗: 24 hours postoperatively
A numeric pain rating scale will be used - a higher pain score would indicate higher pain levels. It is scaled 0-10.
次要结局
- Length of Stay as Measured by Same Day Discharges(From surgery until discharge)
- Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)(Within 24 hours postoperatively)
- Renal Injury as Measured by the Change in Creatinine Levels(From preoperative baseline labs while hospitalized, up to 1 week)
- Nausea Score as Measured by a Likert Scale(24 hours postoperatively)
- Length of Stay as Measured by Hospital Nights(From surgery until discharge)
- Length of Stay as Measured by Hours in the Hospital(Until patient discharged from the hospital)
研究者
Victor Hugo Hernandez
Professor Chief - Division of Arthroplasty & Adult Reconstruction, Department of Orthopaedics
University of Miami