Randomized Trial on Spinal Anaesthesia vs. General Anaesthesia (SAGA) on Recovery After Total Hip, Total Knee, and Unicompartmental Knee Arthroplasty
Overview
- Phase
- Phase 4
- Intervention
- Spinal anesthesia
- Conditions
- Osteoarthritis, Hip
- Sponsor
- Anders Troelsen
- Enrollment
- 222
- Locations
- 2
- Primary Endpoint
- Ability to be mobilsed safely within 6 hours of surgery
- Status
- Completed
- Last Updated
- 12 months ago
Overview
Brief Summary
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.
Investigators
Anders Troelsen
Professor, consultant physician
Hvidovre University Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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)
Intervention: Spinal anesthesia
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)
Intervention: General anaesthesia
Outcomes
Primary Outcomes
Ability to be mobilsed safely within 6 hours of surgery
Time Frame: within 6 hours postoperatively.
5-meter walking test where a physiotherapist evaluates whether the participant can be safely mobilized within 6 hours of surgery.
Secondary Outcomes
- 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.)