GASPS Study: General Anaesthesia vs Spinal anaesthesia: Patient outcomes and Success in Outpatient primary total knee and hip Arthroplasty

简要总结

主要结局

次要结局

• Time from start of anaesthesia to start of surgery (Phase II).
• Time from start of surgery to discharge from the postoperative recovery unit (Phase II).
• Time from start of surgery to fulfilment of indicators for end phase III (intermediate recovery) as outlined in the protocol (table 4).
• Time from start of surgery to discharge from hospital (Phase III).
• Time from start of surgery to first successful mobilisation, assessed by the ability to walk with tolerable pain and ascend/descend stairs if applicable.
• Use of analgesics (opioids converted to Oral morphine equivalents (OME)).
• Patient-reported quality of recovery using the Swedish Version of Quality of Recovery - 15 (QoR-15) from postoperative day (POD) 1 to POD 35.
• Pain levels measured using the Numeric Rating Scale (NRS) during the recovery period (postoperative until discharge to ward)
• Knee injury and Osteoarthritis Outcome Score (KOOS) at baseline, 4 weeks, 6 months 12 months.
• Hip disability and Osteoarthritis Outcome Score (HOOS), at baseline, 4 weeks, 6 months 12 months.
• Use of analgesics (opioids converted to Oral morphine equivalents (OME)). Daily postoperative day 1-14, weekly day 15-35
• Incidence, severity and frequency of adverse events (AEs) and serious adverse events (SAEs), until postoperative day 3.
• Incidence and frequency of predefined adverse outcomes. (Table 1), until postoperative day 3.
• Units of blood transfusion, until discharge from hospital
• Key themes from patient-reported experiences of anaesthesia and postoperative care, gathered through semi-structured interviews conducted 14–60 days post-surgery.
• Incremental cost-effectiveness ratios (ICERs) comparing costs and quality-adjusted life years (QALYs) gained between GA and SA.