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
- Ability to be mobilsed safely within 6 hours of surgery
研究概览
简要总结
The goal of this randomized clinical trial is to investigate the postoperative recovery following hip and knee arthroplasty procedures depending on the use of either spinal anaesthesia (SA) or general anaesthesia (GA).
The main questions are:
- Are more patients able to be safely mobilized within 6 hours postoperatively when using GA compared to SA?
- Does postoperative pain, nausea and vomiting, dizzyness, occurence of delirium and urinary retention differ between the anaesthetic methods?
Participants, scheduled for total hip, total knee and unicomartmental knee arthroplasty, will be randomized to recieve spinal anaesthesia or general anaesthesia in relation to surgery. At 6 hours postoperatively a physiotherapist will conduct a 5-meter walking test to evaluate whether the participant can be safely mobilized.
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)
盲法说明
Physcians and nurses in the surgical department are not able to be blinded. But outcome assesors (ie. physiotherapists, research personel) are not aware of the treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and radiological hip or 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.
- •Women considered fertile but without sufficient birth control.
研究组 & 干预措施
Spinal Anaesthesia (SA)
Patients undergoing total hip, total knee or unicompartmental knee arthroplasty are anaesthetized using:
Plain or heavy Bupivacaine hydrochloride 10 mg (2 mL)
干预措施: Spinal anesthesia (Drug)
General Anaesthesia (GA)
Patients undergoing total hip, total knee or unicompartmental knee arthroplasty are anaesthetized using:
Propofol (induction: 1.0-2.0 mg/kg. infusion: 3-5 mg/kg/hour) + Remifentanil (induction: 3-5 mcg/kg, infusion: 0.5 mcg/kg/min)
干预措施: General anaesthesia (Drug)
结局指标
主要结局
Ability to be mobilsed safely within 6 hours of surgery
时间窗: within 6 hours postoperatively.
5-meter walking test where a physiotherapist evaluates whether the participant can be safely mobilized within 6 hours of surgery.
次要结局
- Fulfilment of discharge criteria(On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted.)
- Pain score(On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted.)
- Opioid use in Morphine Milligram Equivilents within the first 6 hours of surgery(On the day of surgery: Within the first 6 hours after surgery.)
- Nausea Score(On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted.)
研究者
Anders Troelsen
Professor, consultant physician
Hvidovre University Hospital