Outcomes After Total Knee Joint Arthroplasty: A Comparative Study Using 3 Different Analgesic Techniques
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Primary outcome - Perioperative pain
研究概览
简要总结
This study is designed to determine if one anaesthetic modality, either motor sparing nerve block or peri-articular local infiltration anaesthesia with infusion, is superior in providing postoperative analgesia following total knee joint arthroplasty and if the efficacy of analgesia affects TKA outcomes. These outcomes include pain and function for a period of up to 3 months, narcotic consumption, and specific non-pain complications, including cardiac, respiratory, central nervous system, thromboembolism, infection, nausea and vomiting and urinary retention.
Economic outcomes will also be examined, including length of hospital stay, direct health care costs and patient satisfaction.
详细描述
Seventy patients of either sex with ASA physical status of 1-3, aged greater than 30 years scheduled for elective primary unilateral total knee arthroplasty will be the randomized to one of 2 groups. The patients will be identified by the surgeons and seen in the pre-admit clinic to obtain informed consent, and collect health and joint related data using SF-12, Knee Society Scores, and WOMAC surveys. The randomization will occur in the pre-admit clinic with a closed envelope system. This is not a blinded study for logistical reasons.
Group 1: Control- Motor Sparing Nerve Block Continuous Motor sparing knee block (using 60mL of 0.5% Ropivacaine with 10 mg Morphine, 30 mg Ketorolac and 150 mcg of epinephrine as the initial bolus) initiated in the preoperative period in the block room by anesthesia as per the standard practice( 25mL for posterior knee infiltration, 5mL for LFCN, 25mL for adductor canal under the fasica lata, 5ML for intermediate cutaneous nerve of thigh) and continued until discharge. CADD infusion pump will deliver Ropivacaine 0.2% at a basal infusion rate of 8 mL/Hr with no patient controlled boluses.
Group 2: Intervention- Local Infiltration + Infusion Anesthetic Wound infiltration will first be completed per standard practice using 110mL of ropivacaine 300mg, ketorolc 30mg ,morphine 10mg for infiltration. After, three peri-articular catheters (inserted into the suprapatellar pouch, anterior subcutaneous cutaneous tissue, posterior to the femur) will be inserted at the end of the case followed by periarticular infusion with CADD infusion pump delivering Ropivacaine 0.2% at a basal infusion rate of 8 mL/Hr with no patient controlled boluses
All patients will receive sedation with fentanyl and midazolam titrated to effect during the initiation of spinals and MSNB blocks. All patients will receive intravenous sedation with an infusion of a mixture of propofol and ketamine titrated to effect during surgery. Patients will be discharged home following removal of the anaesthetic catheters and fulfilling criteria for discharge
All patients will receive standard multimodal analgesia pre- and post-operatively.
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
- None
入排标准
- 年龄范围
- 30 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients ASA physical status 1-3, Ability to give informed consent, No contraindications to regional techniques, Ability to perform study related tests, Scheduled for primary unilateral total knee arthroplasty
排除标准
- •Revision of arthroplasty, Allergy to local anesthetics and multimodal analgesic drugs, Contraindications to spinal anesthesia, Inability to perform study related procedures, Inability to give informed consent, Wheel chair bound, Pregnancy, Chronic renal failure, BMI >45
结局指标
主要结局
Primary outcome - Perioperative pain
时间窗: day of surgery to 2 weeks post-op
Postoperative pain levels on a visual analogue scale will be recorded while the patient is an inpatient up to a maximum of 4 days post-discharge, and again at 2 weeks post-op.
次要结局
- Nausea and Sedation symptoms(day of surgery to post-discharge day 4)
- Readiness and True Discharge times(in-patient period)
- Analgesia/Narcotic Consumption(day of surgery to post-discharge day 4)
- Patient reported pain, stiffness and functional disability.(Assessed preoperatively, and at 6 weeks and 3 months postoperative.)
- Postoperative mobility/function(Measured on day of surgery to discharge day 4. Functional outcomes will be collected at 6 weeks and 3 months post-op using WOMAC and KSS scores)
- Complications(day of surgery to 3 months post-op)
- Short-From Survey-12(Assessed preoperatively, and at 6 weeks and 3 months postoperative.)
- Anaesthetic Procedure Performance Data(peri-operatively)
研究者
James Howard
Professor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's