Optimizing Pain and Rehabilitation After Knee Arthroplasty - Randomized, Blinded Clinical Trial Comparing Continuous Femoral Nerve Block Versus Single Injection Femoral Nerve Block Versus Local Infiltration Analgesia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Numeric Rating Scale for Pain
研究概览
简要总结
The aim of this study is to determine the best method of pain control that will help with rehabilitation after total knee arthroplasty (TKA). Currently, the best method for pain control after TKA appears to be continuous femoral nerve block (FNB) where a small tube is placed beside the nerve that provides sensation to a large part of the knee and local anesthetic infused after surgery causing numbness to the surgical site. A single injection method also exists and may provide similar benefits. Both methods require training and can result in side effects such as temporary weakness (while the local anesthetic is still working) that can inhibit rehabilitation. A newer method injecting local anesthetic into the joint after surgery (Local Infiltration Analgesia (LIA)) is becoming common, does not cause weakness and can be done quickly at the end of surgery. It is unknown if the pain control provided by LIA is as good as that of FNB. This study will compare the femoral nerve block, continuous femoral nerve block and LIA technique to determine which provides better pain relief after TKA.
详细描述
This will be a prospective, randomized, double blind study. Patients will be randomized using a computer-generated sequence to one of three groups:
Group 1: Continuous femoral nerve block group (cFNB) Group 2: Single injection femoral nerve block group (sFNB) Group 3: Local infiltration analgesia group (LIA)
Inclusion criteria: Patients between the ages of 18 and 85 having primary tri-compartmental total knee arthroplasty.
Exclusion criteria: Allergy, intolerance, or contraindication to any study medication (see below), inability to walk independently prior to TKA, inability to comprehend French or English, use of major tranquilizers, ASA 4 or 5, BMI > 40, opioid tolerance (opioid consumption > 30mg oral morphine or equivalent per day), pregnancy
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults undergoing primary, tri-compartmental knee arthroplasty
排除标准
- •Allergy, intolerance, or contraindication to any study medication
- •Inability to walk independently prior to TKA
- •Inability to comprehend French or English
- •Use of major tranquilizers
- •ASA 4 or 5
- •BMI > 40
- •Opioid tolerance (opioid consumption > 30mg oral morphine or equivalent per day)
- •Pregnancy
结局指标
主要结局
Numeric Rating Scale for Pain
时间窗: 09h00 on postoperative day 2
Pain at this time is the primary impediment to beginning physiotherapy and achieving discharge criteria
次要结局
- Opioid consumption(Cumulative 4 day consumption)
- Knee range of motion(Measured each postoperative day (4 day maximum) during daily physiotherapy session)
- Six minute walk test(Measured once at the first postoperative visit with the surgeon, 6 weeks postoperative)
- WOMAC(Baseline questionnaire given preoperatively, at first postoperative visit (6 weeks), and second postoperative visit (3 months))
- Complications of femoral nerve block, local infiltration analgesia(From date of randomization until the first postoperative visit at 6 weeks)
- Inability to ambulate/falls(Participants will be followed for the duration of hospital stay, an expected average of 4 days)
- LEFS(Baseline questionnaire given preoperatively, at first postoperative visit (6 weeks), and second postoperative visit (3 months))
- Incidence of motor block(Participants will be followed for the duration of hospital stay, an expected average of 4 days)
- NRS for pain(The highest NRS will be assessed daily during the patient's physiotherapy session, as well as the highest NRS achieved at 2 weeks, 6 weeks, and 3 months postoperatively)
- Timed up and go(Measured once on postoperative day 2 during the physiotherapy session)
- Nausea(Participants will be followed for the duration of hospital stay, an expected average of 4 days)
研究者
Dr. Stephen Choi
Staff Anesthesiologist, Associate Professor Department of Anesthesia
Sunnybrook Health Sciences Centre