Continuous Adductor Canal Block in Fast Track Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- opioid consumption
研究概览
简要总结
Total knee arthroplasty (TKA) is a frequent performed surgery. Many institutions are implementing fast track programs for this surgery and adequate pain management is an important feature. Analgesic duration of single shot nerve blocks is limited to no more than 24h. Conversely, the use of continuous nerve block (CNB) through a perineural catheter and infusion of local anesthetic may increase duration of analgesia and provide better outcomes. The purpose of this study is to evaluate effectiveness and safety of using CNB in patients undergoing ambulatory TKA, and its effects on patients' quality of recovery. Investigators hypothesize that continuous adductor canal block would lead to decrease in opioid consumption in patients undergoing fast track TKA.
Significance There are no published prospective randomized controlled trials to assess patient's reported quality of recovery after receiving CACB in same day primary knee arthroplasties. As this is a frequent type of surgery and has the prediction to increase its incidence for the next years, there is significant importance in investigations about interventions which may improve its recovery in a fast track regime. A postoperative analgesic technique that offers better pain control, has less adverse effects, reduces the opioid analgesia requirement and is safe to be used in a fast track setting may have additional impact on decreasing health care cost and may lead to an enhanced recovery and better quality of life.
Objectives To evaluate effectiveness and safety of using CACB in patients undergoing ambulatory TKA, in comparison to SACB. Primary objective is opioid consumption (in oral morphine equivalent doses) Secondary objectives are to evaluate postoperative QoR-15 scores (10), pain scores, opioid-induced adverse effects (measured via validated opioid symptom distress scale), postoperative functional status, complications relating to the perineural catheter and readmissions.
详细描述
Objectives The aim of this study is to examine the effect of CACB on decreasing opioid consumption, increasing the Quality of Recovery (measured via QoR-15) total score and decreasing opioid-related side effects. Investigators will also assess the rate of readmissions in primary knee arthroplasty patients.
Rationale
Pain management in knee arthroplasty patients poses unique challenges for the anesthesiologist, especially in the immediate post-operative period. Early postoperative analgesia is limited to a unimodality of intravenous opioids. Recently, adductor canal blocks have started to replace femoral blocks, as this technique can provide similar analgesic results while avoiding the quadriceps muscle weakness associated with femoral nerve blocks. The use of a continuous adductor canal catheter in the post-discharge phase shows promising as the next step in knee arthroplasty pain management allowing for shorter lengths of stay or even same day discharge (3).
Significance and Innovation
Total knee arthroplasty (TKA) is the second most common inpatient surgery in the U.S. and Canada, and is associated with severe postoperative pain, limiting early ambulation and optimal functional recovery. Perioperative opioid use has been linked with many adverse outcomes including opioid dependence. This study aims to demonstrate the utility of CACB as an adjunct strategy to reduce opioid consumption and improve quality of recovery in primary knee arthroplasty patients. The innovation in this approach lies not only in less opioid consumption and opioid induced side effects but also in reducing the burden of postoperative pain, leading to an enhanced recovery and better quality of life. Establishing the safeness of this method in an outpatient setting may have the additional impact of decreasing health care costs and may lead to reduce opioid prescriptions on discharge from the hospital.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing unilateral primary TKA in the fast track setting.
- •Patients older than 21 years of age, with American Society of Anesthesiologists (ASA)
- •Physical status I-III
- •No alcohol or drug dependency
- •Sufficient understand and co-operation about the perineural catheter.
排除标准
- •Perioperative complication or discharge delay leading to hospital admission.
- •Chronic opioid use of morphine 30mg equivalent per day for last 2 consecutive weeks.
- •Allergy to the study medications;
- •Coagulopathy and platelet count < 105/μL;
- •Patients with contraindications to the insertion of an epidural or adductor canal catheter (severe anatomic abnormalities or history of previous surgery at the site of catheter placement).
研究组 & 干预措施
CACB
continuous adductor canal block
干预措施: continuous adductor canal block (CACB) ropivacaine (Drug)
Control group
sham continuous adductor canal block - ShACB
干预措施: sham continuous adductor canal block - ShACB NaCl (Drug)
结局指标
主要结局
opioid consumption
时间窗: At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively
opioid consumption. Total opioid consumption changes will be assessed at 24, 48, 72 hours, seven, 30 and 90 days postoperatively.
次要结局
- Intensity of postoperative pain(At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively)
- Quality of Recovery(At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively)
- Opioid related side effects(At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively)
研究者
Dr. Naveed Siddiqui
Principal Investigator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital