Does Continuous Adductor Canal Nerve Block Improve the Quality of Recovery for Outpatient Total Knee Arthroplasty Patients?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Quality of Recovery Scale 15 (QoR-15)
研究概览
简要总结
This is a randomized, double-blinded pilot study to determine whether patients undergoing ambulatory total knee arthroplasty (TKA) using a subvastus approach benefit from the addition of a continuous adductor canal nerve block (cACB) catheter along with an existing multimodal approach to postoperative analgesia. Outcomes include the 15-item Quality of Recovery Scale (QoR-15) (Miles 2016), pain scores, opioid consumption, opioid-free days, functional outcome as measured by the Time Up and Go (TUG) test, patient satisfaction, patient's rating of catheter effectiveness, and complications.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •patient characteristics suitable for subvastus approach as determined by single surgeon
- •patients willing to undergo ambulatory surgery
- •ability to read and verbally communicate via either English or French
排除标准
- •driving distance greater than 1 hour from hospital
- •no willing caregiver at home on night of surgery
- •renal failure requiring dialysis
- •Insulin-dependent diabetes mellitus
- •allergy to study medications
- •pre-existing neurologic deficit involving the ipsilateral limb
- •chronic high dose opioid use (defined as >200mg/day of morphine equivalent for over 2 weeks).
- •inability to use or manage cACB catheter and pump independently at home
- •inability or refusal to cryocompressive therapy device.
研究组 & 干预措施
Saline infusion
Participants in this group will receive normal saline infusion (5ml/hr, patient controlled bolus 5ml, lockout 30min) in the adductor canal, starting in PACU on post-operative day 0 and continuing for 96 hours
干预措施: Normal Saline (Drug)
Ropivacaine infusion
Participants in this group will receive ropivacaine 0.2% infusion (5ml/hr, patient controlled bolus 5ml, lockout 30min) in the adductor canal, starting in PACU on post-operative day 0 and continuing for 96 hours
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Quality of Recovery Scale 15 (QoR-15)
时间窗: at 4pm on post-operative day (POD) 1
QoR-15 is a validated scale calculated from a 15-question patient questionnaire. It is an aggregate score that evaluates recovery after surgery.
次要结局
- Pain score at rest(POD 1-4 + 7)
- Quality of Recovery Scale 15 (QoR-15)(POD 2-4 + 7)
- Tapentadol consumption(POD 1-4 + 7)
- Pain score with activity(POD 1-4 + 7)
- Patient-rated catheter effectiveness(POD 1-4)
- Vital signs - blood pressure, heart rate, oxygen saturation(twice daily POD 1-4)
- Catheter specific complications(POD 1-4)
- Peri-operative complications(POD 30)
- Patient satisfaction(POD 1-4 + 7)
- Timed-up-and-go (TUG) test(POD 14)