About this trial
Beneficial and harmful effects of spinal versus general anaesthesia in patients undergoing hip and knee arthroplasty.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for elective primary elective hip or knee arthroplasty, including unicompartmental knee
Disqualifiers
Scheduled for elective primary hip or knee arthroplasty, including unicompartmental knee
Age ≥ 18 years
Unable to communicate in written and/or spoken Danish Contraindications against either spinal or general anaesthesia
Trial design
Parallel
Treatments tested in this trial
Spinal anaesthesia
Procedure/SurgerySpinal anaesthesia according to local practice, including optional sedation with sedative-hypnotic pharmacological agents
General anaesthesia
Procedure/SurgeryGeneral anaesthesia according to local practice
Treatment groups
Trial outcomes
Primary outcomes
Hospital-free days within 30 days
Defined as the number of days within the first 30 days following hip or knee arthroplasty surgery during which a participant is alive and not admitted to a hospital.
Secondary outcomes
Major complications
A major complication is defined as a major intra- or postoperative adverse event occurring from the initiation of anaesthesia through 30 days postoperatively.
Quality of Recovery
The Quality of Recovery-15 questionnaire (QoR-15) generates a composite score ranging from 0 to 150 across five domains (physical comfort, emotional state, physical independence, psychological support, and pain), with higher scores indicating better recovery.
Other outcomes
Patient satisfaction with anaesthesia
Assessed 24 hours postoperatively by asking patients to rate their satisfaction on a numeric rating scale (NRS) from 0-10, where 0 indicates not satisfied at all/completely dissatisfied and 10 indicates extremely satisfied/fully satisfied.
Health-related quality of life (EQ5D5L-VAS)
Evaluation of health-related quality of life using the EuroQol EQ5D5L- VAS questionnaire that adresses mobility, self-care, usual activities, pain/discomfort, anxiety/depression. The VAS is a vertical visual analogue score of self-rated health (EQ-VAS, 0 = "The worst health you can imagine" and 100 = "The best health you can imagine").
Number of unplanned hospital-visits
Defined as the number of any unplanned contact with the emergency department, outpatient clinic, or other hospital department.
Willingness to repeat the type of anaesthesia
Assessed at 24 hours postoperatively by asking participants whether they would choose the same type of anaesthesia again in case of future surgery.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: