Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- opioid consumption (MME) postoperatively
研究概览
简要总结
This is a prospective, cluster-randomized, two-arm, comparative study aimed at determining whether addition of tizanidine ( an oral muscle relaxant) to a multimodal pain regimen following primary TKA reduces opioid consumption.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis.
- •ASA I - III
- •Spinal anesthesia
- •All patients will have a total knee arthroplasty utilizing a medial parapatellar approach with cruciate sacrificing implants and patellar resurfacing. A tourniquet will be used in all cases.
- •Men and women between 18 and 80 years who are willing and able to provide informed consent
排除标准
- •Opioid use greater than 10 mg/day morphine equivalents continuously for one month within 3 months preoperatively
- •Inability to take/allergy to the protocol medications
- •Contraindication to regional anesthesia
- •Non-English speaking
- •ASA IV or greater
- •Psychiatric or cognitive disorders
- •Allergy/contraindications to protocol medications.
- •Renal insufficiency with Cr > 2.0 or hepatic failure
- •Sensory/motor disorder involving the operative limb
- •PCS score >20
- •Patients with severe cardiac or neurological conditions precluding the use of study medications
- •Patients using anticoagulation other than aspirin for the 14-day period after discharge
研究组 & 干预措施
Multimodal Pain Regimen + Tizanidine
current standard of care post-operative pain regimen in the hospital, which comprises of standing doses of oral acetaminophen 975 mg three times a day, gabapentin 300 mg two times a day, and intravenous ketorolac 30 mg three times a day for patients <65 years and 15 mg IV Q8h for patients who are >65 years, supplemented with PRN oxycodone and tramadol supplemented with standing doses of oral tizanidine in the hospital and for 14 days after discharge
干预措施: TiZANidine 2 MG Oral Capsule (Drug)
结局指标
主要结局
opioid consumption (MME) postoperatively
时间窗: the first 14-days postoperatively
Primary outcome is patients total opioid consumption for the first 14 days after surgery.
次要结局
未报告次要终点