[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inflammatory-joint-disease-ijd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inflammatory-joint-disease-ijd":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":4},"100618631","phase-4-general-anaesthesia-vs-spinal-anaesthesia-patient-outcomes-and-success-in-outpatient-primary-total-knee-and-hip-arthroplasty-100618631",false,"NCT07334132","General Anaesthesia vs Spinal Anaesthesia: Patient Outcomes and Success in Outpatient Primary Total Knee and Hip Arthroplasty","GASPS","Inclusion Criteria:\n\n1. The participant has given their written consent to participate in the trial.\n2. Planned for primary TKA or THA.\n3. Adults aged 18 to 80 years at time of written consent.\n4. ASA (American Society of Anaesthesiologists) classification 1 or 2, or 3 without significant functional impairment.\n5. Scheduled start of surgery before 13:00.\n6. Ability to communicate in Swedish, ensuring understanding of informed consent and follow-up procedures.\n\nExclusion Criteria:\n\n1. Indication for surgery other than degenerative or inflammatory joint diseases (e.g. fracture).\n2. Body mass index (BMI) \\> 35 kg\u002Fm.\n3. Preoperative opioid use exceeding 20 mg oral morphine equivalents daily.\n4. Haemoglobin \\\u003C 120 g\u002FL (sample no older than 3 months).\n5. Known bleeding disorders, including coagulopathies.\n6. Known allergies to investigational anaesthetic drugs (e.g., bupivacaine, remifentanil, or propofol).\n7. Neurological conditions with persistent motor or sensory deficits.\n8. Localised infections at the spinal injection site.\n9. Determined by the surgical or anaesthesia team to be unsuitable for trial participation and\u002For outpatient surgery.\n10. Women of childbearing potential (i.e., those who are fertile, following menarche and until becoming post-menopausal, unless permanently sterile)\n\n    1. Who are not willing to use a highly effective method of contraception judged by the investigator, from the time of signing the informed consent, OR\n    2. Who has a positive pregnancy test at enrolment","ALL","18 Years","80 Years",{"count":20,"type":21},600,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are common operations used to treat severe joint disease, most often caused by osteoarthritis. An increasing number of these procedures are now performed as outpatient surgery, meaning that patients can go home on the same day as the operation. This can be beneficial for both patients and healthcare systems, but it requires safe and efficient anaesthetic care.\n\nTwo different types of anaesthesia are commonly used for these operations: general anaesthesia (where the patient is asleep) and spinal anaesthesia (where the lower part of the body is numbed). Both methods are well established and widely used. Previous studies suggest that the choice of anaesthesia may affect how quickly patients recover, how comfortable they feel after surgery, and whether they can be safely discharged on the day of surgery. However, most existing studies are based on retrospective data, and there is limited randomized evidence comparing these anaesthetic techniques in the outpatient setting.\n\nThe GASPS trial is a multicentre, randomized, phase IV clinical study that compares general anaesthesia and spinal anaesthesia in adults undergoing outpatient primary total knee or hip arthroplasty. A total of 600 participants will be included and randomly assigned to receive one of the two anaesthetic methods on the day of surgery. All participants will receive standard surgical and perioperative care, and both anaesthetic techniques are part of routine clinical practice.\n\nThe main aim of the study is to investigate whether the type of anaesthesia influences the chance of successful same-day discharge, defined as going home on the day of surgery without needing to be readmitted within 48 hours. The study will also examine recovery time, pain, nausea and vomiting, use of pain medication, complications, patient-reported recovery and function, and healthcare costs. In addition, patient experiences of anaesthesia and postoperative recovery will be explored through interviews in a smaller group of participants.\n\nParticipants will be followed using questionnaires and medical records from the day of surgery up to 12 months after the operation. The results of this study are expected to provide clear and reliable information to help guide anaesthetic care for patients undergoing outpatient hip and knee replacement surgery.",[27,28,29],"Osteo Arthritis Knee and Hip","Osteo Arthritis","Inflammatory Joint Disease (IJD)",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49],"Total Knee Arthroplasty","Total Hip Arthroplasty","Outpatient Surgery","Same-Day Discharge","Ambulatory Arthroplasty","General Anaesthesia","Spinal Anaesthesia","Neuraxial Anaesthesia","Total Intravenous Anaesthesia","Postoperative Recovery","Quality of Recovery","QoR-15","Postoperative Pain","Postoperative Nausea and Vomiting","PONV","Patient-Reported Outcomes","Health Economic Evaluation","Cost-Effectiveness","Randomized Clinical Trial","NOT_YET_RECRUITING","2026-01-02",{"date":53,"type":54},"2026-01-12","ACTUAL",{"date":56,"type":21},"2026-04-01",{"date":58,"type":21},"2029-12-31",{"name":60,"class":61},"Region Örebro County","OTHER"]