REMIFENTANIL HYDROCHLORIDE for Total knee arthroplasty | Total hip arthroplasty

Inclusion criteria

• {"criterion_text":"- 1.\tThe participant has given their written consent to participate in the trial."}
• {"criterion_text":"- 2.\tPlanned for primary TKA or THA."}
• {"criterion_text":"- 3.\tAdults aged 18 to 80 years at time of written consent."}
• {"criterion_text":"- 4.\tASA (American Society of Anesthesiologists) classification 1 or 2, or 3 without significant functional impairment."}
• {"criterion_text":"- 5.\tScheduled start of surgery before 13:00."}
• {"criterion_text":"- 6.\tAbility to communicate in Swedish, ensuring understanding of informed consent and follow-up procedures."}

Exclusion criteria

• {"criterion_text":"- 1.\tIndication for surgery other than degenerative or inflammatory joint diseases (e.g. fracture)."}
• {"criterion_text":"- 2.\tBody mass index (BMI) > 35 kg/m."}
• {"criterion_text":"- 3.\tPreoperative opioid use exceeding 20 mg oral morphine equivalents daily."}
• {"criterion_text":"- 4.\tHaemoglobin <120 g/L (sample no older than 3 months)."}
• {"criterion_text":"- 5.\tKnown bleeding disorders, including coagulopathies."}
• {"criterion_text":"- 6.\tKnown allergies to investigational anaesthetic drugs (e.g., bupivacaine, remifentanil, or propofol)."}
• {"criterion_text":"- 7.\tNeurological conditions with persistent motor or sensory deficits."}
• {"criterion_text":"- 8.\tLocalised infections at the spinal injection site."}
• {"criterion_text":"- 9.\tDetermined by the surgical or anaesthesia team to be unsuitable for trial participation and/or outpatient surgery."}
• {"criterion_text":"- 10.\tWomen of childbearing potential (i.e., those who are fertile, following menarche and until becoming post-menopausal, unless permanently sterile) a.\tWho are not willing to use a highly effective method of contraception judged by the investigator, OR b.\tWho has a positive pregnancy test at enrolment"}
• {"criterion_text":"- 11.\tIndividual unwilling or unable to receive either spinal or general anaesthesia"}
• {"criterion_text":"- 12.\tParticipation or recent participation in a clinical trial with an investigational medicinal product within 30 days."}
• {"criterion_text":"- 13.\tPrevious participation in this trial."}

Primary endpoints

• {"endpoint_text":"- Successful same-day discharge, defined as: •\tThe patient is discharged from the hospital on the same day as the surgery and, •\tthe patient is not readmitted within 48 hours of discharge.","definition_or_measurement_approach":"Successful same-day discharge defined as discharge on the day of surgery AND no readmission within 48 hours; measured by discharge records and readmission within 48 hours."}

Secondary endpoints

• {"endpoint_text":"- Time from start of anaesthesia to start of surgery (Phase II).","definition_or_measurement_approach":"Measured interval from anaesthesia start time to surgical incision start (timing logs)."}
• {"endpoint_text":"- Time from start of surgery to discharge from the postoperative recovery unit (Phase II).","definition_or_measurement_approach":"Measured interval from surgery start to discharge from recovery unit (timing logs)."}
• {"endpoint_text":"- Time from start of surgery to fulfilment of indicators for end phase III (intermediate recovery) as outlined in the protocol (table 4).","definition_or_measurement_approach":"Measured interval from surgery start to fulfilment of protocol-specified Phase III recovery indicators (per protocol table 4)."}
• {"endpoint_text":"- Time from start of surgery to discharge from hospital (Phase III).","definition_or_measurement_approach":"Measured interval from surgery start to hospital discharge (timing logs)."}
• {"endpoint_text":"- Time from start of surgery to first successful mobilisation, assessed by the ability to walk with tolerable pain and ascend/descend stairs if applicable.","definition_or_measurement_approach":"Measured interval from surgery start to first mobilisation meeting criteria (ability to walk with tolerable pain and ascend/descend stairs if applicable)."}
• {"endpoint_text":"- Use of analgesics (opioids converted to Oral morphine equivalents (OME)).","definition_or_measurement_approach":"Analgesic consumption converted to OME and recorded over specified periods."}
• {"endpoint_text":"- Patient-reported quality of recovery using the Swedish Version of Quality of Recovery - 15 (QoR-15) from postoperative day (POD) 1 to POD 35.","definition_or_measurement_approach":"QoR-15 questionnaire administered POD1 through POD35; scores compared between groups."}
• {"endpoint_text":"- Pain levels measured using the Numeric Rating Scale (NRS) during the recovery period (postoperative until discharge to ward)","definition_or_measurement_approach":"Pain assessed using NRS during recovery period until ward discharge."}
• {"endpoint_text":"- Knee injury and Osteoarthritis Outcome Score (KOOS) at baseline, 4 weeks, 6 months 12 months.","definition_or_measurement_approach":"KOOS questionnaires at baseline, 4 weeks, 6 months, and 12 months."}
• {"endpoint_text":"- Hip disability and Osteoarthritis Outcome Score (HOOS), at baseline, 4 weeks, 6 months 12 months.","definition_or_measurement_approach":"HOOS questionnaires at baseline, 4 weeks, 6 months, and 12 months."}
• {"endpoint_text":"- Use of analgesics (opioids converted to Oral morphine equivalents (OME)). Daily postoperative day 1-14, weekly day 15-35","definition_or_measurement_approach":"Daily OME recording POD1-14 and weekly recording day15-35."}
• {"endpoint_text":"- Incidence, severity and frequency of adverse events (AEs) and serious adverse events (SAEs), until postoperative day 3.","definition_or_measurement_approach":"AE/SAE collection and classification through POD3 (incidence, severity, frequency)."}
• {"endpoint_text":"- Incidence and frequency of predefined adverse outcomes. (Table 1), until postoperative day 3.","definition_or_measurement_approach":"Assessment of predefined adverse outcomes per protocol Table 1 until POD3."}
• {"endpoint_text":"- Units of blood transfusion, until discharge from hospital","definition_or_measurement_approach":"Count of units transfused until hospital discharge."}
• {"endpoint_text":"- Key themes from patient-reported experiences of anaesthesia and postoperative care, gathered through semi-structured interviews conducted 14–60 days post-surgery.","definition_or_measurement_approach":"Qualitative analysis of semi-structured interviews conducted 14–60 days post-surgery to identify themes."}
• {"endpoint_text":"- Incremental cost-effectiveness ratios (ICERs) comparing costs and quality-adjusted life years (QALYs) gained between GA and SA.","definition_or_measurement_approach":"Health economic evaluation calculating ICERs (costs per QALY) between groups."}

Sweden

Earliest CTIS Part Ii Submission Date

29-09-2025

Latest Decision Or Authorization Date

12-03-2026

Processing Time Days

164

Number Of Sites

2

Number Of Participants

600

Primary sponsor

Full Name

Region Oerebro Laen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden