Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty: A Single Institution, Single-blinded, Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 209
- 试验地点
- 1
- 主要终点
- Pain Control at 72 Hours Postoperatively
研究概览
简要总结
The purpose of this study is to compare an FDA-approved medication for post-operative pain control (HTX-011) to the standard of care institutional practice for periarticular analgesia after primary total knee arthroplasty (weight based dosing of Ropivacaine, epinephrine and ketorolac diluted with saline). We are doing this research study to find out if this new medication provides superior pain control within 72 hours following 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
- Single (Participant)
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
- •ASA classification I to III, older than or equal to 18 years old.
- •Presenting for primary total knee replacement for degenerative joint disease.
- •Patient capable of providing their own informed consent.
排除标准
- •Vulnerable study populations including prisoners.
- •Patients with a contralateral total knee arthroplasty < 2 years prior to the index procedure.
- •Compromised health barring them from proceeding with surgery including acute or chronic kidney injury identified pre-operative.
- •Patients unable to provide their own informed consent.
- •Pregnancy.
- •Patients with documented chronic pain syndromes.
- •Patients with a history of prolonged daily opioids (more than 1 month) with an oral morphine equivalent of greater than 5mg/day.
- •BMI > 45 kg/m^
- •Allergies to any component of the study medications, including specific history of type 1 hypersensitivities to any NSAID.
- •Patients with impaired cognitive function.
- •Major systemic illnesses such as severe renal (estimated glomerular filtration rate less than 50ml/min), coronary artery disease requiring a bypass graft (CABG), other cardiac problems including congestive heart failure (CHF New York Heart Association class III to IV), or severe hepatic disorders defined as current or past diagnosis of acute/subacute liver necrosis, acute hepatic failure, chronic liver disease, liver abscess, hepatic coma, hepatorenal syndrome and other disorders of the liver.
研究组 & 干预措施
HTX-011 Treatment Group
Subjects undergoing a total knee arthroplasty will receive HTX-011 (Zynrelef) for perioperative analgesia
干预措施: HTX-011 (Drug)
Standard Block Control Group
Subjects undergoing a total knee arthroplasty will receive standard of care arthroplasty block for perioperative analgesia
干预措施: ropivacaine , epinephrine , ketorolac diluted in sodium chloride (Drug)
结局指标
主要结局
Pain Control at 72 Hours Postoperatively
时间窗: 72-hours postoperatively after total knee arthroplasty
Area Under the Curve (AUC) of the graph for mean Numerical Rated Score (NRS) for pain (0-10) over time (0-72 hours) / NRS AUC 0-72. Pain scores were collected by patient self-report 15 times over the 72 hours after surgery, and averaged amongst the patients for each study arm. Lower values represent better pain control based on lower mean 0-10 pain scores over the 72 hour period after surgery. The minimum value is 0, meaning patients reported 0 pain on a 0-10 scale at all 15 time points within 72 hours. The maximum value would be 720, meaning patients reported a 10 for pain on a 0-10 scale at all 15 time points within 72 hours.
次要结局
- Opioid Consumption 72 Hours Postoperatively(72-hours postoperative total knee arthroplasty)
- Opioid Consumption 48 Hours Postoperatively(48 hours postoperative total knee arthroplasty)
- Pain Control at 48 Hours Postoperatively(48-hours postoperative total knee arthroplasty)
研究者
Matthew P. Abdel, M.D.
Principal Investigator
Mayo Clinic