The Effect of Regional Anesthesia and Periarticular Injection and Versus Periarticular Injection Alone on Early Recovery After Total Knee Arthroplasty: A Prospective Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Mean Visual Analog Scale (VAS) pain score for 2 weeks postoperatively
研究概览
简要总结
The purpose of the study is to compare two types of perioperative analgesic modalities, adductor canal block plus interspace between popliteal artery and capsule of the knee (IPACK) block and periarticular injection versus periarticular injection alone, to determine their relative efficacies with regard to pain relief and functional outcomes in the early postoperative period following primary total knee arthroplasty.
详细描述
The widespread adoption of multimodal analgesia in contemporary total knee arthroplasty (TKA) has led to improvements in perioperative pain control, expedited recovery times, and shorter hospital stays1-3. Periarticular injections (PAIs), adductor canal blocks (ACBs), and interspace between popliteal artery and capsule of the knee (IPACK) blocks are commonly utilized as part of contemporary multimodal analgesia protocols, but their relative efficacies in improving early recovery after TKA has yet to be definitively elucidated4. There are a few known potential drawbacks of ACBs and IPACKs including surgical delay due to administration timing, increased costs, and small risks associated with a regional block. Both regional anesthesia and PAI have been found to be effective alone in improving pain and opioid consumption, but there is limited data on whether there is an additive benefit of providing both treatments for patients undergoing primary TKA. Therefore, the purpose of our study is to compare the efficacy of regional anesthesia and PAI vs. PAI alone for pain management and functional recovery in the early postoperative period following TKA.
Design Prospective randomized trial
Treatment Groups All ACBs will be administered as a single shot preoperatively in the holding area on the day of surgery by the regional anesthesia team and PAIs will be administered intraoperatively by the treating orthopaedic surgeon.
Group 1: regional anesthesia (ACB + IPACK) and PAI Group 2: PAI alone
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
patients will not know which group they are in
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
- •Planning to undergo Unilateral primary total knee arthroplasty.
- •18 and up
- •Willing to sign informed consent
- •Willing to return for all follow-up visits
- •Smartphone or tablet device capable of running the FocusMotion platform
排除标准
- •BMI > 45
- •Preexisting functionally limiting neurologic disorders
- •Hepatic or renal insufficiency
- •History of unprovoked venous thromboembolism
- •Inability to complete baseline functional testing
- •Chronic opioid or gabapentin and pregabalin use (chronic defined as use >5 days per week prior to the surgical procedure)
- •Allergy or intolerance to trial medications
- •Planned admission to a postoperative rehabilitation facility
- •Planned general anesthesia
- •Receiving workers compensation or disability payments
研究组 & 干预措施
Periarticular injectin alone
Periarticular injection alone
干预措施: PAI (Drug)
Block and Periarticular injection
regional anesthesia (Adductor canal block +IPACK) and Periarticular injection
干预措施: PAI (Drug)
Block and Periarticular injection
regional anesthesia (Adductor canal block +IPACK) and Periarticular injection
干预措施: regional anesthesia and PAI (Drug)
结局指标
主要结局
Mean Visual Analog Scale (VAS) pain score for 2 weeks postoperatively
时间窗: at 2 weeks
pain score 0-10 10 being more pain
Mean Visual Analog Scale (VAS) Pain Score for 2 Weeks Postoperatively
时间窗: at 2 weeks
pain score 0-10 10 being more pain
次要结局
- daily resting Visual Analog Scale (VAS) score(daily up to 2 weeks postop)
- knee range of motion(daily through app and knee brace up to 2 weeks postop)
- length of stay(postop day 1)
- daily opioid consumption(daily up to 2 weeks postop)
- daily step count(daily up to 2 weeks postop)
- complications(14 days postop)
- sleep quality(daily up to 2 weeks postop)
- Oxford knee score(weekly up to 2 weeks postop)
- Opioid Use(postop day 2)
- Daily Step Count at 2 Weeks Postop(2 weeks postop)
- Oxford Knee Score(baseline)
- Sleep Quality Via Survey That Patients Completed Ranging From Very Good Sleep and Fairly Good Sleep(baseline % of very good sleep and fairly good sleep)
- Oxford Knee Score(7 days postop)
- Oxford Knee Score(14 days postop)
- Sleep Quality Via App Surveys With Range of Very Good Sleep and Fairly Good Sleep(7 days postop % of fairly good to very good sleep)
- Sleep Quality Via App Surveys With Range of Very Good Sleep to Fairly Good Sleep(14 days postop % of very good sleep to fairly good sleep)