2022-501221-21-00已完成4 期
Randomized trial on Spinal Anaesthesia vs. General Anaesthesia (SAGA) on recovery after total hip, total knee, and unicompartmental knee arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 2
- 主要终点
- Whether or not the participant is able to safely and independently walk 5 meters (also when using walking aid) within 6 hours of surgery.
研究概览
简要总结
Investigating whether or not participants are able to safely and independently walk 5 meters (also when using walking aid) within 6 hours of surgery depending on the type of anaesthesia used.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Clinical and radiological knee osteoarthritis meeting the indications for primary total hip, total knee or unicompartmental knee arthroplasty. ≥18 years of age. Able to speak and understand Danish. Able to give informed consent and must be cognitively intact.
排除标准
- •Lives in an institution. Uses walking aid such as a walker or a wheelchair. Terminal illness. Has contraindications for either general or spinal anaesthesia. Has objections to receiving either general or spinal anaesthesia. Requires anxiolytics as premedication prior to anaesthesia. Traumatic aetiology as a basis for surgical indication. Altered pain perception and / or neurologic affection due to diabetes or other disorders. Daily preoperative use of opioids > 30 mg of morphine milligram equivalents (MME). Standard primary arthroplasty procedure is evaluated not to be suitable.
结局指标
主要结局
Whether or not the participant is able to safely and independently walk 5 meters (also when using walking aid) within 6 hours of surgery.
Whether or not the participant is able to safely and independently walk 5 meters (also when using walking aid) within 6 hours of surgery.
次要结局
- Fulfilment of discharge criteria
- Pain score and opioid use
- Postoperative nausea and vomiting (PONV)
- Dizziness score
- Quality of Recovery (QoR-15)
- Opioid-Related Symptom Distress Scale (ORSDS) questionnaire
- 3-minute Diagnostic Interview – Confusion Assessment Method (3D-CAM)
- Urinary retention
- Emergency room contacts, complications, readmission or mortality within 30 days of surgery
研究者
Christian Bredgaard Jensen
Scientific
Hvidovre Hospital
研究点 (2)
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