Comparison of the Analgesic Efficacy of Continuous Femoral Nerve Block and Adductor Canal Block With Steroid Adjuvant in Patients Undergoing Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative pain score (visual analogue scale 0-10) at 6h,12h, 24h,48h, 72h after surgery
研究概览
简要总结
We hypothesize continuous adductor canal block with steroid adjuvant would offer no inferior analgesics and rehabilitation ability than continuous femoral nerve block for postoperative patients receiving total knee arthroplasty.
详细描述
A total of 80 patients who will undergo total knee arthroplasty will be randomized into two groups:
Treatment groups Treatment details Femoral Group (40 patients) Continuous femoral nerve block (bolus: 0.5% Ropivacaine 10-15 ml ; infusion of 0.15 % Ropivacaine 4-6ml/h) Adductor Group (40 patients) Adductor canal block with steroid adjuvant (bolus: 0.5% Ropivacaine 10-15ml; Dexamethasone 4mg) (Total 80 patients will be recruited)
- All patients will receive single shot tibial nerve block with local anaesthetics (0.5% Ropivacaine 5-8ml) before surgery for analgesia of posterior knee.
- All patients will receive the same preemptive and postoperative multimodal medications for perioperative analgesia.
- All groups will receive standardized method of spinal anaesthesia and standardized method of intraoperative sedation for the surgery.
- Intravenous patient controlled analgesia (PCA) with morphine will be given for 48h to patient as rescue analgesia.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary osteoarthritis
- •Scheduled for elective total knee arthroplasty
- •Signed written informed consent
- •Planned use of spinal anaesthesia
- •Cognitive sound to use assessment tools
排除标准
- •Patients refusing to give consents
- •Scheduled for revision total knee replacement
- •Patient outside range of 30 to 80 yrs old
- •Non-chinese population
- •Cognitive impairment/ inability to use the outcome assessment tools
- •Contraindications to regional anesthesia
- •severe cardiovascular disease (unstable angina, second or third degree heart block)
- •pre-existing neurologic disease including psychiatric disorder
- •drug abuser
- •Pre-operative history of neurological abnormality in the ipsilateral leg e.g. history of stroke, neurogenic pain or previous nerve injury.
- •Allergy or contraindication to drugs used in this study: morphine, Non-steroidal anti-inflammatory drugs (NSAID) such as ketorolac , diclofenac, dihydrocodeine, local anaesthetics (lignocaine, ropivacaine, bupivacaine), epinephrine
- •Moderate or severe renal impairment (serum creatinine > 160 micromol/l)
结局指标
主要结局
Postoperative pain score (visual analogue scale 0-10) at 6h,12h, 24h,48h, 72h after surgery
时间窗: 6h,12h, 24h,48h, 72h after surgery
PCA morphine or pain rescuer consumption at 24h and 48h postoperative
时间窗: 24h and 48h postoperative
Quadriceps strength at 24h, 48h, 72h postoperative
时间窗: 24h, 48h, 72h postoperative
using dynamometer (measure in Newton/centimeter square)
次要结局
- Incidence of side effects and complications at postoperative day 0- 4 postoperative(postoperative period 0-96 hr postoperative)
- Patient satisfaction score (0-4)(upon discharge)
- Haemastix on call and every 8 hours after surgery for postoperative 24hours for patients(on call and every 8 hours after surgery for postoperative 24h)
- Length of Stay in hospital 6. Length of Stay in hospital length of hospital stay(upon discharge)
- postoperative nausea or vomiting(0-72h)
- postoperative pruritis(0-72h)
研究者
Dr Hui Kit Man Grace
Associate Consultant, Dept of Anaesthesia and Operating Services
Queen Elizabeth Hospital, Hong Kong