Adductor Canal Block and Functional Recovery After Total Knee Arthroplasty. A Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Timed Up and Go test
研究概览
简要总结
This study aims to compare the functional recovery of patients undergoing Total Knee Arthroplasty based on the administration of an adductor canal block during their anesthesia treatment
详细描述
The period after total knee replacement (TKR) surgery is known to be painful for the first 24 hours, lasting up to 3 days in many cases. Successful management of pain after TKR is regarded as necessary to early recovery, rehabilitation and timely discharge. Severe pain following major joint arthroplasty can hinder early rehabilitation, may result in prolonged hospitalization and is a strong predictor of persistent pain beyond 3 months. Adequate analgesia following TKR is paramount to early recovery, rehabilitation and timely discharge. Therefore early postoperative analgesic and rehabilitation goals are intricately related.
Until now, different methods of pain treatment have been used, including intravenous narcotic pain medication, continuous femoral nerve block (numbing medication to a nerve in the thigh) and epidural analgesia (identical to the numbing method for childbirth). These are all effective methods but each is limited by side effects. In recent years, research has focused on administering local anesthetic further down in the leg, trying to minimize quadriceps muscle weakness while giving adequate pain relief after surgery. Local Infiltration Analgesia (LIA) and Adductor Canal Block (ACB) are examples of new farther sites of administration.
The purpose of this study is to determine which combination of analgesic interventions is the most effective treatment for pain and improvement in functional outcome for TKR.
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
- Double (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
- •American Society of Anesthesiologists Physical Status I-III
- •18 - 80 years of age
- •BMI 18 - 40
- •Scheduled for elective total knee replacement under spinal anesthesia
- •Able to ambulate independently with a standard wheeled walker as maximum mobility aid
排除标准
- •Revision knee arthroplasty
- •Bilateral knee arthroplasty
- •Lack of mental ability to provide informed consent
- •Neuropathic pain or sensory disorders of the surgical limb
- •Contraindication to regional anesthesia (intolerance to the study drugs, bleeding diathesis, coagulopathy, malignancy or infection at the site of block)
- •Chronic opioid use defined as > 30 mg of daily oral morphine equivalents
研究组 & 干预措施
Local Inflitration Only
This group will receive LIA and saline solution (placebo) in the adductor canal block with NO morphine in the spinal anesthesia:
- 30 ml normal saline
- 3ml 0.5% preservative-free bupivacaine
干预措施: Local Infiltration (Drug)
Adductor Canal Block
This group will receive LIA and the standard local anesthetic in the ACB with NO morphine in the spinal anesthetic:
- ropivacaine 0.5% with 1:400,000 epinephrine
- 3ml 0.5% preservative-free bupivacaine
干预措施: Adductor Canal Block (Drug)
Adductor Canal Block with Morphine
This group will receive LIA with local anesthetic in the ACB and morphine in the spinal anesthetic:
- ropivacaine 0.5% with 1:400,000 epinephrine
- 3ml 0.5% preservative-free bupivacaine with 100mcg of intrathecal morphine (0.1ml of intrathecal morphine 1mg/ml)
干预措施: Adductor Canal Block with Morphine (Drug)
结局指标
主要结局
Timed Up and Go test
时间窗: 2-3 days post srugery
TUG test reflects the time it takes a subject to stand up from a standard height armchair, walk 3 meters, walk back to the chair and sit down. It intends to assess a patient's global mobility as well as balance and risk of falling.
次要结局
- Pain outcome - NRS(2-3 days post surgery)
- Analgesic outcomes - Cumulative systemic opioid consumption(2-3 days post surgery)
- Analgesic outcomes - Proportion of patients who required "rescue" intravenous patient controlled analgesia(2-3 days post surgery)
- Analgesic outcomes - Incidence of opioid-related side effects(2-3 days post surgery)
- Secondary short-term physical and performance-based functional outcome measures - Proportion of patients achieving knee flexion range of motion (ROM) of 90 degrees(2-3 days post surgery)
- Secondary short-term physical and performance-based functional outcome measures - Distance walked(2-3 days post surgery)
- Secondary short-term physical and performance-based functional outcome measures - Hospital length of stay(2-3 days post surgery)
- Secondary short-term physical and performance-based functional outcome measures - Discharge destination(2-3 days post surgery)
- Medium-term self-reported functional outcome measures - WOMAC(baseline and 2-3 days post surgery)
- Medium-term self-reported functional outcome measures - LEFS(baseline and 2-3 days post surgery)