NCT04003350已完成不适用
The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Opioid related side effects
研究概览
简要总结
It is well recognized that a multimodal analgesia program targeting multiple pain pathways, is more effective for controlling pain during the hospital stay and in the acute postoperative period than monotherapy-based regimens, such as opioids only. This multimodal analgesic regimen also leads to reduce opioid consumption and its related side effects after hip and knee joint replacement procedures. One potential strategy to reduce the use of opioids after TKA is to administer a prolonged oral multimodal pain regimen that targets multiple pain pathways in the post hospital discharge period. This can be equal or more effective than the regimen of opioid prescriptions used after TKA. To the best of our knowledge, there have been no studies conducted that directly examine the effect of prolonged multimodal pain regimen after hospital discharge in primary TKA patients.
PURPOSE:
- To determine whether a prolonged multimodal pain regimen after discharge from primary TKA can provide equivalent or better pain control while reducing opioid consumption and, subsequently, opioid-related side effects.
- To determine whether patient expectations and routine opioid prescription practices at the time of discharge from primary TKA impacts 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis.
- •ASA I - III
- •Spinal anesthesia
- •All patients will have cemented total knee utilizing a medial parapatellar approach including patellar resurfacing. A tourniquet will be used in all cases
- •Male and Female over 18 who are willing and able to provide informed consent
排除标准
- •Opioid use within 3 months preoperatively
- •Inability to take the protocol medications
- •Anticoagulant other than aspirin
- •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
- •General anesthesia
- •Sensory/motor disorder involving the operative limb
研究组 & 干预措施
Multimodal pain regimen with PRN opioids
Experimental
Weeks 1-4
- Tylenol 1000 mg q8h (standing)
- Meloxicam 15 mg qD (standing).
- Gabapentin 200 mg BID (with morning and evening Tylenol dose)
- Metaxalone 800mg PO TID (Tizanidine 2mg q8h if insurance coverage is not possible for metaxalone)
- Esomeprazole 20mg daily if not already on another H2 blocker or PPI
- Oxycodone 5 mg PRN q4h (30 tablets)
- Tramadol 50 mg PRN q6h (30 tablets)
干预措施: Esomeprazole 20mg (Drug)
Opioid Regimen
Active Comparator
Weeks 1-4
- Oxycodone 5 mg PRN q4h (30 tablets)
- Tramadol 50 mg PRN q6h (30 tablets)
干预措施: Oxycodone (Drug)
Opioid Regimen
Active Comparator
Weeks 1-4
- Oxycodone 5 mg PRN q4h (30 tablets)
- Tramadol 50 mg PRN q6h (30 tablets)
干预措施: Tramadol (Drug)
Multimodal pain regimen with PRN opioids
Experimental
Weeks 1-4
- Tylenol 1000 mg q8h (standing)
- Meloxicam 15 mg qD (standing).
- Gabapentin 200 mg BID (with morning and evening Tylenol dose)
- Metaxalone 800mg PO TID (Tizanidine 2mg q8h if insurance coverage is not possible for metaxalone)
- Esomeprazole 20mg daily if not already on another H2 blocker or PPI
- Oxycodone 5 mg PRN q4h (30 tablets)
- Tramadol 50 mg PRN q6h (30 tablets)
干预措施: Oxycodone (Drug)
Multimodal pain regimen with PRN opioids
Experimental
Weeks 1-4
- Tylenol 1000 mg q8h (standing)
- Meloxicam 15 mg qD (standing).
- Gabapentin 200 mg BID (with morning and evening Tylenol dose)
- Metaxalone 800mg PO TID (Tizanidine 2mg q8h if insurance coverage is not possible for metaxalone)
- Esomeprazole 20mg daily if not already on another H2 blocker or PPI
- Oxycodone 5 mg PRN q4h (30 tablets)
- Tramadol 50 mg PRN q6h (30 tablets)
干预措施: Tramadol (Drug)
Multimodal pain regimen with PRN opioids
Experimental
Weeks 1-4
- Tylenol 1000 mg q8h (standing)
- Meloxicam 15 mg qD (standing).
- Gabapentin 200 mg BID (with morning and evening Tylenol dose)
- Metaxalone 800mg PO TID (Tizanidine 2mg q8h if insurance coverage is not possible for metaxalone)
- Esomeprazole 20mg daily if not already on another H2 blocker or PPI
- Oxycodone 5 mg PRN q4h (30 tablets)
- Tramadol 50 mg PRN q6h (30 tablets)
干预措施: Tylenol (Drug)
Multimodal pain regimen with PRN opioids
Experimental
Weeks 1-4
- Tylenol 1000 mg q8h (standing)
- Meloxicam 15 mg qD (standing).
- Gabapentin 200 mg BID (with morning and evening Tylenol dose)
- Metaxalone 800mg PO TID (Tizanidine 2mg q8h if insurance coverage is not possible for metaxalone)
- Esomeprazole 20mg daily if not already on another H2 blocker or PPI
- Oxycodone 5 mg PRN q4h (30 tablets)
- Tramadol 50 mg PRN q6h (30 tablets)
干预措施: Meloxicam (Drug)
Multimodal pain regimen with PRN opioids
Experimental
Weeks 1-4
- Tylenol 1000 mg q8h (standing)
- Meloxicam 15 mg qD (standing).
- Gabapentin 200 mg BID (with morning and evening Tylenol dose)
- Metaxalone 800mg PO TID (Tizanidine 2mg q8h if insurance coverage is not possible for metaxalone)
- Esomeprazole 20mg daily if not already on another H2 blocker or PPI
- Oxycodone 5 mg PRN q4h (30 tablets)
- Tramadol 50 mg PRN q6h (30 tablets)
干预措施: Gabapentin (Drug)
Multimodal pain regimen with PRN opioids
Experimental
Weeks 1-4
- Tylenol 1000 mg q8h (standing)
- Meloxicam 15 mg qD (standing).
- Gabapentin 200 mg BID (with morning and evening Tylenol dose)
- Metaxalone 800mg PO TID (Tizanidine 2mg q8h if insurance coverage is not possible for metaxalone)
- Esomeprazole 20mg daily if not already on another H2 blocker or PPI
- Oxycodone 5 mg PRN q4h (30 tablets)
- Tramadol 50 mg PRN q6h (30 tablets)
干预措施: Metaxalone (Drug)
结局指标
主要结局
Opioid related side effects
时间窗: post-surgery days 1-30
Severity measured via Visual Analog scale (0-100mm)
Post-operative pain
时间窗: Postsurgery days 1-30
Measured via Visual Analog scale (0-100mm)
次要结局
- number of opioid refills(post-surgery weeks 1-4)
- opioid consumption(post-surgery weeks 1-4)
- 90 day complications(post-surgery 90 days)
研究者
研究点 (1)
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