An Analysis of the Functional Benefit, Narcotic Use and Time to Discharge Readiness Following the Implementation of a Comprehensive Pain Management Protocol for Primary Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Time to Discharge
研究概览
简要总结
Study question: Is there an ideal combination of intraoperative long acting analgesics (periarticular infiltration (PI), femoral nerve block (FB) and intrathecal opioids (IO)) to optimize post-operative functional recovery, decrease overall narcotic consumption and enable faster 'readiness to discharge' for patients undergoing primary total knee replacement (TKR)?
详细描述
Our study design is a five-arm double blinded randomized control trial. In order to create a blinded study, each participant will have all three interventions (Femoral Nerve Block (FB), Periarticular Injection (PI) and Intrathecal Opioid (IO)) performed during their visit. Normal saline (NS) will be substituted for opioid or local anesthetic in cases where a control is required.
Specific 5 arms include:
- Using all three anesthetics:
o PI + FB + IO (arm 1)
-
Using a combination of two anesthetics + normal saline substitute for control:
-
NS + FB + IO (arm 2)
-
PI + NS + IO (arm 3)
-
PI + FB + NS (arm 4)
-
Control:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age 18 years or older
- •primary total knee replacement for osteoarthritis
- •agrees to a spinal anesthetic for TKR
排除标准
- •History of chronic pain or opioid tolerance (individuals requiring equivalent of 1 mg or more intravenous or 3 mg or more oral morphine per hour for greater than 1 month)
- •general anesthetic for TKR
- •major neurological deficit
- •allergy to local anesthetic
- •allergy to morphine or hydromorphone, anti-inflammatory, acetaminophen
- •renal insufficiency
- •liver failure
研究组 & 干预措施
Arm 1: PI+FNB+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Bupivicaine (Drug)
Arm 1: PI+FNB+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Fentanyl (Drug)
Arm 3: PI+NS+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Bupivicaine (Drug)
Arm 1: PI+FNB+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Epimorphine (Drug)
Arm 1: PI+FNB+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Ropivicaine (Drug)
Arm 1: PI+FNB+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Epinephrine (Drug)
Arm 1: PI+FNB+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Ketorolac (Drug)
Arm 1: PI+FNB+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Ropivicaine with Epinephrine (Drug)
Arm 2:NS+FNB+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with1:400,000 Epinephrine 30ml, Normal Saline 100ml
干预措施: Bupivicaine (Drug)
Arm 2:NS+FNB+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with1:400,000 Epinephrine 30ml, Normal Saline 100ml
干预措施: Fentanyl (Drug)
Arm 2:NS+FNB+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with1:400,000 Epinephrine 30ml, Normal Saline 100ml
干预措施: Epimorphine (Drug)
Arm 2:NS+FNB+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with1:400,000 Epinephrine 30ml, Normal Saline 100ml
干预措施: Normal Saline (Drug)
Arm 2:NS+FNB+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with1:400,000 Epinephrine 30ml, Normal Saline 100ml
干预措施: Ropivicaine with Epinephrine (Drug)
Arm 3: PI+NS+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Fentanyl (Drug)
Arm 3: PI+NS+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Epimorphine (Drug)
Arm 3: PI+NS+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Normal Saline (Drug)
Arm 3: PI+NS+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Ropivicaine (Drug)
Arm 3: PI+NS+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Epinephrine (Drug)
Arm 3: PI+NS+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Ketorolac (Drug)
Arm 4: PI+FNB+NS
Bupivicaine 15mg, Fentanyl 15mcg, Normal Saline 0.3ml, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Bupivicaine (Drug)
Arm 4: PI+FNB+NS
Bupivicaine 15mg, Fentanyl 15mcg, Normal Saline 0.3ml, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Fentanyl (Drug)
Arm 4: PI+FNB+NS
Bupivicaine 15mg, Fentanyl 15mcg, Normal Saline 0.3ml, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Normal Saline (Drug)
Arm 4: PI+FNB+NS
Bupivicaine 15mg, Fentanyl 15mcg, Normal Saline 0.3ml, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Ropivicaine (Drug)
Arm 4: PI+FNB+NS
Bupivicaine 15mg, Fentanyl 15mcg, Normal Saline 0.3ml, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Epinephrine (Drug)
Arm 4: PI+FNB+NS
Bupivicaine 15mg, Fentanyl 15mcg, Normal Saline 0.3ml, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Ketorolac (Drug)
Arm 4: PI+FNB+NS
Bupivicaine 15mg, Fentanyl 15mcg, Normal Saline 0.3ml, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
干预措施: Ropivicaine with Epinephrine (Drug)
Arm 5:NS+NS+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Normal Saline 100ml
干预措施: Bupivicaine (Drug)
Arm 5:NS+NS+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Normal Saline 100ml
干预措施: Fentanyl (Drug)
Arm 5:NS+NS+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Normal Saline 100ml
干预措施: Epimorphine (Drug)
Arm 5:NS+NS+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Normal Saline 100ml
干预措施: Normal Saline (Drug)
结局指标
主要结局
Time to Discharge
时间窗: Post-op day 1 to discharge date or day 5
Meeting discharge criteria - Participants will be followed for the duration of hospital stay, approximately 3-5 days
次要结局
- Time up and go performance measures(Post-op day1 to discharge date or day 5)
- Complications(Post-op day 0 to discharge date or day 5)
- Total Opioid Consumption Measures(Post-op day 0 to discharge date or day 5)