Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- Opioid consumption
研究概览
简要总结
Previous retrospective database studies suggest that total knee arthroplasty (TKA) surgery under spinal anesthesia has less complications than when performed under general anesthesia. In general, complications are rare and both anesthesia types are widely accepted. In Finland, total knee arthroplasty has typically been performed under spinal anesthesia.
In a recent prospective randomized controlled study, total knee arthroplasty under general anesthesia resulted in less acute postoperative pain (opioid-need measured by patient-controlled anesthesia), less nausea, and faster hospital discharge than that performed under spinal anesthesia. Also the use of surgical tourniquet can affect surgical outcome: it may reduce bleeding and surgery time, but it may also cause weakness of thigh muscles and thus hinder mobilization. In a recent study, both techniques with and without surgical tourniquet appeared equal.
The aims of this study are to compare total knee arthroplasty under spinal or general anesthesia, with or without surgical tourniquet, in relation to acute and chronic postoperative pain, nausea, knee function, patient reported quality of life and satisfaction on care, complications, length of stay, and need of surgical unit resources. This randomized controlled study includes 400 patients with informed consent, 18-75-years-of-age, standard primary total knee arthroplasty operation, American Society of Anesthesiologist (ASA) physical status classification I-III, body mass index under 40, and no contraindications for medications or treatments used.
The hypothesis of this study are used to reassess best practices of primary total knee arthroplasty operation to enhance quality of care, patient outcomes and satisfaction, and availability of surgery due to better patient flow at surgical unit.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for total knee arthroplasty exists (patient has osteoarthritis, rheumatoid arthritis or other disease affecting knee joint that does not respond to conservative treatment)
- •Patient understands the study information and is willing to participate
- •Triathlon endoprosthesis is suitable for patient
- •ASA Physical Status Classification 1-3
- •Patient will be operated by a surgeon who has done at least 100 total knee arthroplasty procedures with Triathlon endoprosthesis before
排除标准
- •BMI > 40 kg/m2
- •ASA Physical Status Classification > 3
- •Valgus or varus > 15° degrees in the knee that will be operated
- •Extension deficit ≥ 20° or flexion ≤ 90° in the knee that will be operated
- •Earlier major (open) surgery in the knee that will be operated
- •Contraindication for drugs used in the study
- •Contraindication for either spinal or general anesthesia
- •Glomerular filtration rate < 60ml/min/1.73m2 (by Chronic Kidney DIsease Epidemiology Collaboration formula)
- •Known or suspected disease affecting the function of liver
- •Preoperative use of strong opioids
- •Patient is pregnant, cognitively disabled, under guardianship, a prisoner or in compulsory military service
- •Patient will be operated by a surgeon who has done less than 100 total knee arthroplasty procedures before or by a surgeon who does not operate with Triathlon endoprosthesis
- •Day of the surgery is not suitable for study (no research personnel available for 24 hours postoperative evaluation)
研究组 & 干预措施
Spinal anesthesia with tourniquet
This group will be operated under spinal anesthesia (15 mg of bupivacaine) and in continuous light propofol sedation. Surgical tourniquet (with the pressure of 250 mmHg or > 100 mmHg higher than systolic blood pressure) is used during the operation.
Local infiltration analgesia (LIA) will be administered during the operation. Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the removal of the tourniquet.
Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours.
干预措施: Spinal anesthesia with tourniquet (Procedure)
Spinal anesthesia with tourniquet
This group will be operated under spinal anesthesia (15 mg of bupivacaine) and in continuous light propofol sedation. Surgical tourniquet (with the pressure of 250 mmHg or > 100 mmHg higher than systolic blood pressure) is used during the operation.
Local infiltration analgesia (LIA) will be administered during the operation. Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the removal of the tourniquet.
Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours.
干预措施: Oxycodone by patient-controlled analgesia (PCA) (Drug)
Spinal anesthesia without tourniquet
This group will be operated under spinal anesthesia (15 mg of bupivacaine) and in continuous light propofol sedation. Surgical tourniquet is not used during the operation.
Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the surgical incision. Local infiltration analgesia (LIA) will be administered during the operation.
Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours.
干预措施: Spinal anesthesia without tourniquet (Procedure)
Spinal anesthesia without tourniquet
This group will be operated under spinal anesthesia (15 mg of bupivacaine) and in continuous light propofol sedation. Surgical tourniquet is not used during the operation.
Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the surgical incision. Local infiltration analgesia (LIA) will be administered during the operation.
Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours.
干预措施: Oxycodone by patient-controlled analgesia (PCA) (Drug)
General anesthesia with tourniquet
This group will be operated under general anesthesia (propofol and remifentanil are used with target-controlled infusion (TCI) mode) and surgical tourniquet (with the pressure of 250 mmHg or > 100 mmHg higher than systolic blood pressure) is used during the operation.
Local infiltration analgesia (LIA) will be administered during the operation. Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the removal of tourniquet. Intravenous bolus of oxycodone 0.1 mg/kg (ideal body weight) is given when the closure of surgical wound begins.
Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours.
干预措施: General anesthesia with tourniquet (Procedure)
General anesthesia with tourniquet
This group will be operated under general anesthesia (propofol and remifentanil are used with target-controlled infusion (TCI) mode) and surgical tourniquet (with the pressure of 250 mmHg or > 100 mmHg higher than systolic blood pressure) is used during the operation.
Local infiltration analgesia (LIA) will be administered during the operation. Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the removal of tourniquet. Intravenous bolus of oxycodone 0.1 mg/kg (ideal body weight) is given when the closure of surgical wound begins.
Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours.
干预措施: Oxycodone by patient-controlled analgesia (PCA) (Drug)
General anesthesia without tourniquet
This group will be operated under general anesthesia (propofol and remifentanil are used with target-controlled infusion (TCI) mode) without the use of surgical tourniquet.
Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the surgical incision. Local infiltration analgesia (LIA) will be administered during the operation. Intravenous bolus of oxycodone 0.1 mg/kg (ideal body weight) is given when the closure of surgical wound begins.
Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours.
干预措施: General anesthesia without tourniquet (Procedure)
General anesthesia without tourniquet
This group will be operated under general anesthesia (propofol and remifentanil are used with target-controlled infusion (TCI) mode) without the use of surgical tourniquet.
Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the surgical incision. Local infiltration analgesia (LIA) will be administered during the operation. Intravenous bolus of oxycodone 0.1 mg/kg (ideal body weight) is given when the closure of surgical wound begins.
Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours.
干预措施: Oxycodone by patient-controlled analgesia (PCA) (Drug)
结局指标
主要结局
Opioid consumption
时间窗: 24 hours postoperative
Cumulative intravenous oxycodone consumption By patient controlled analgesia (PCA) 24 hours postoperative.
次要结局
- Medications given for postoperative nausea and vomiting (PONV)(an average of 2 to 3 days postoperative)
- Predictive value of chronic pain risk index(an average of 1-2 weeks preoperative and 24 hours, 3 months and 12 months postoperative)
- Knee function(an average of 1-2 weeks preoperative, 3 and 12 months postoperative)
- Complications(12 months postoperative)
- Postoperative nausea(an average of 0-3 hours and 24 hours postoperative)
- Chronic postoperative pain(an average of 1-2 weeks preoperative, 3 and 12 months postoperative)
- Acute postoperative pain(24 hours postoperative)
- Times at the operation unit(from operating room to end of treatment in recovery room, an average of 3-5 hours)
- Need for "rescue" analgesia(From recovery room to the end of hospital stay, an average of 2-3 days)
- Self-reported quality of life(an average of 1-2 weeks preoperative, 3 and 12 months postoperative)
- Patient satisfaction and self-reported complications(3 and 12 months postoperative)
- Need for vasoactive medications, urine catheter and ventilatory support(intraoperative - an average of 2-3 days)
- Bleeding(3 months to 1 day preoperative, intraoperative, 15-24 hours postoperative)
- Hospital length of stay(an average of 2 to 3 days up to 3 months)
研究者
Riku Antero Palanne
Principal investigator
Helsinki University Central Hospital