[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657039":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":48,"studyPopulation":42,"armGroups":49,"interventions":60,"overallOfficials":42,"centralContacts":42,"locations":42,"responsibleParty":70,"collaborators":42,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":42,"enrollmentInfo":84,"targetDuration":42,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":42,"overallStatus":101,"whyStopped":42,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":42},{"fullName":5,"class":6},"Zealand University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Postoperative day 0-30",[14,17],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":20},"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.","24 hours postoperatively",[22,25,29,32,35],{"measure":23,"description":24,"timeFrame":20},"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\u002Fcompletely dissatisfied and 10 indicates extremely satisfied\u002Ffully satisfied.",{"measure":26,"description":27,"timeFrame":28},"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\u002Fdiscomfort, anxiety\u002Fdepression. 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\").","Postoperative day 30",{"measure":30,"description":31,"timeFrame":12},"Number of unplanned hospital-visits","Defined as the number of any unplanned contact with the emergency department, outpatient clinic, or other hospital department.",{"measure":33,"description":34,"timeFrame":20},"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.",{"measure":36,"description":37,"timeFrame":38},"Day-case discharge","Number of patients assessed as eligible for day-case surgery being discharged on the day of surgery.","Postoperative day 0",{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":42,"timePerspective":42,"maskingInfo":44},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":45,"maskingDescription":42,"whoMasked":46},"SINGLE",[47],"OUTCOMES_ASSESSOR","Effective and safe anaesthesia is fundamental to perioperative care. Hip and knee arthroplasty are among the most frequently performed surgical procedures worldwide and are typically performed under either spinal or general anaesthesia. However, high-quality comparative evidence regarding the benefits and harms of these anaesthetic techniques remains limited and inconclusive.\n\nBoth techniques are associated with short- and long-term risks, including postoperative nausea and vomiting, hypotension, nerve injury, acute kidney injury, and respiratory and cardiovascular complications. In addition, they may differentially modulate the surgical stress response, potentially influencing postoperative recovery and risk of complications.\n\nObjective:\n\nTo compare the benefits and harms of spinal versus general anaesthesia in patients undergoing hip or knee replacement. We hypothesise that spinal anaesthesia results in better postoperative outcomes than general anaesthesia.\n\nIntervention:\n\nPatients undergoing elective primary hip or knee arthroplasty will be randomised to receive either spinal or general anaesthesia, with randomisation stratified by participating centre.\n\nDesign:\n\nThe SPIGA trial is an investigator-initiated, multicentre, randomised, superiority clinical trial. Participants will be randomly allocated at a 1:1 ratio using a central, computer-generated randomisation sequence. A total sample size of 3000 participants was determined using simulation-based methods to provide at least 90% power to detect a prespecified minimally clinically important difference, corresponding to an increase of one hospital-free day in at least 10% of participants at a two-sided significance level of 0.05.\n\nPlanned sub-studies\n\n* Short-term perioperative outcomes (0-24h postoperatively)\n* Stratified analysis of anaesthetic regimens\n* Impact of preoperative clinical frailty",[50,55],{"label":51,"type":52,"description":42,"interventionNames":53},"Spinal Anaesthesia","EXPERIMENTAL",[54],"Procedure: Spinal anaesthesia",{"label":56,"type":57,"description":42,"interventionNames":58},"General Anaesthesia","ACTIVE_COMPARATOR",[59],"Procedure: General anaesthesia",[61,66],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":42},"PROCEDURE","Spinal anaesthesia","Spinal anaesthesia according to local practice, including optional sedation with sedative-hypnotic pharmacological agents",[51],{"type":62,"name":67,"description":68,"armGroupLabels":69,"otherNames":42},"General anaesthesia","General anaesthesia according to local practice",[56],{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"PRINCIPAL_INVESTIGATOR","Ole Mathiesen","MD, PhD, Chair Professor","100657039","anaesthesia-for-hip-and-knee-arthroplasty-spiga-100657039",false,"NCT07834242","Anaesthesia for Hip and Knee Arthroplasty (SPIGA)","Spinal Versus General Anaesthesia for Hip and Knee Arthroplasty. The Randomised, Clinical, Multicentre SPIGA Trial","SPIGA","Inclusion Criteria:\n\n* Scheduled for elective primary elective hip or knee arthroplasty, including unicompartmental knee\n\nExclusion Criteria:\n\n* Scheduled for elective primary hip or knee arthroplasty, including unicompartmental knee\n* Age ≥ 18 years\n* Unable to communicate in written and\u002For spoken Danish Contraindications against either spinal or general anaesthesia","ALL","18 Years",{"count":85,"type":86},3000,"ESTIMATED","INTERVENTIONAL",[89],"NA","Beneficial and harmful effects of spinal versus general anaesthesia in patients undergoing hip and knee arthroplasty.",[92,93,94,95,96,97,98,99,100],"Hip Arthroplasty","Knee Arthroplasty","Spinal Anesthesia","General Anesthesia","Length of Hospital Stay","Postoperative Complications","Patient Satisfaction","Quality of Recovery (QoR-15)","Health-Related Quality-of-Life (EQ-5D-5L)","NOT_YET_RECRUITING","2026-09-24",{"date":104,"type":105},"2026-09-29","ACTUAL",{"date":107,"type":86},"2026-10",{"date":109,"type":86},"2031-09",{"name":5,"class":6}]