The Secret Recipe for Femoral Nerve Blockade After Total Knee Arthroplasty: A Randomized, Placebo-controlled, Double-blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Time to readiness to discharge from hospital
研究概览
简要总结
Patients undergoing total knee arthroscopy (knee replacement) surgery usually receive a femoral nerve block as part of their anesthetic care. Some centers administer the block with a single shot of local anesthetic, which wears off several hours after surgery. Other centers administer the block with a single shot followed by continuous infusion of local anesthetic, typically for 2 to 5 days after surgery. The latter method, though good for pain control, may result in decreased mobility (while the anesthetic is still active), longer hospital stays, and greater risk of falls.
This study will see if using a lower concentration of local anesthetic for the continuous femoral nerve block or only the initial single-shot dose will result in increased mobility and shorter hospital stays.
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 (Participant, 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
- •ASA physical status I-III
- •18-85 years of age, inclusive
- •Able to communicate in English sufficiently to participate in the study
- •Able to walk 30 metres without stopping prior to surgery
排除标准
- •Intended discharge to in-patient rehabilitation facility
- •Patient refusal of FNB or spinal anesthetic or sciatic nerve block
- •Contraindications to peripheral nerve block (e.g. allergy to local anesthetics, refusal)
- •Significant peripheral neuropathy or neurological disorder affecting the lower extremity
- •Contraindication to a component of multi-modal analgesia
- •History of use of over 30mg oxycodone or equivalent per day (institutional threshold for acute pain service consultation pre-operatively)
- •History of significant cognitive or psychiatric condition that may affect patient assessment
- •Inability to provide informed consent
研究组 & 干预措施
1
Initial Bolus dose of 0.2% ropivicaine followed by 0.2% ropivicaine infusion until day 2 post-op
干预措施: Bolus of 0.2% ropivicaine 20 mls followed by 0.2% ropivicaine at an infusion rate of 5mls/hr until 0600 on postoperative day 2 (Drug)
2
Initial Bolus dose of 0.2% ropivicaine followed by 0.1% ropivicaine infusion until day 2 post-op
干预措施: Bolus of 0.2% ropivicaine 20 mls followed by 0.1% ropivicaine at an infusion rate of 10mls/hr until 0600 on post-operative day 2 (Drug)
3
Initial Bolus dose of 0.375% ropivicaine followed by saline infusion until day 2 post-op
干预措施: Saline control (Drug)
结局指标
主要结局
Time to readiness to discharge from hospital
时间窗: Twice daily until discharge
次要结局
- Quadriceps strength, knee flexion, walking distance, pain, patient satisfaction, opioid consumption, adverse events, incidence of falls, volume of local anesthetic administered, block success, discharge date, functional recovery(Up to Month 6 post-operative)