About this trial
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.
Two 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.
The 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.
The 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.
Participants 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant has given their written consent to participate in the trial.
Planned for primary TKA or THA.
Adults aged 18 to 80 years at time of written consent.
ASA (American Society of Anaesthesiologists) classification 1 or 2, or 3 without significant functional impairment.
Disqualifiers
Indication for surgery other than degenerative or inflammatory joint diseases (e.g. fracture).
Body mass index (BMI) > 35 kg/m.
Preoperative opioid use exceeding 20 mg oral morphine equivalents daily.
Haemoglobin < 120 g/L (sample no older than 3 months).
Trial design
Parallel
Treatments tested in this trial
General Anaesthesia
DrugGeneral anaesthesia is administered using total intravenous anaesthesia with short-acting agents, primarily propofol and remifentanil. Anaesthesia is delivered intravenously using target-controlled or rate-controlled infusion systems according to routine clinical practice. Airway management and adjunct medications are provided as clinically indicated. The intervention is limited to the intraoperative period, and all other perioperative care follows standard clinical protocols at each study site.
Spinal Anesthesia (bupivacaine)
DrugSpinal anaesthesia is administered as a single-shot intrathecal injection of bupivacaine prior to surgery. Optional intrathecal opioid adjuncts, with fentanyl or sufentanil, may be used to enhance analgesia according to routine clinical practice. Light intravenous sedation may be provided if needed for patient comfort. The intervention is limited to the intraoperative period, and all other perioperative care follows standard clinical protocols at each study site.
Treatment groups
Trial outcomes
Primary outcomes
Successful Same-Day Discharge
Successful same-day discharge is defined as discharge from the hospital on the day of surgery without readmission within 48 hours after discharge. Discharge readiness is assessed by the treating clinical team according to routine clinical criteria. Readmissions are identified through medical record review and patient follow-up.
Secondary outcomes
Time From Start of Anaesthesia to Start of Surgery
Elapsed time from initiation of anaesthesia to the start of surgical incision, recorded intraoperatively.
Time to Discharge From Post-Anaesthesia Care Unit (PACU)
Time from the start of surgery to discharge from the postoperative recovery unit (Phase II), based on predefined discharge criteria.
Time to Fulfilment of Hospital Discharge Criteria
Time from the start of surgery to fulfilment of predefined criteria for discharge from hospital (Phase III), assessed by the clinical care team.
Time to First Successful Mobilisation
Time from the start of surgery to first successful mobilisation, defined as the ability to walk with tolerable pain, and to ascend or descend stairs if applicable.
Locations
Sponsors and contacts
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