Spinal Anaesthesia vs. General Anaesthesia for THA, TKA and UKA (NCT05706844) | Clinical Trial Compass
CompletedPhase 4
Spinal Anaesthesia vs. General Anaesthesia for THA, TKA and UKA
Denmark222 participantsStarted 2023-03-06
Plain-language summary
The goal of this randomized clinical trial is to investigate the postoperative recovery following hip and knee arthroplasty procedures depending on the use of either spinal anaesthesia (SA) or general anaesthesia (GA).
The main questions are:
* Are more patients able to be safely mobilized within 6 hours postoperatively when using GA compared to SA?
* Does postoperative pain, nausea and vomiting, dizzyness, occurence of delirium and urinary retention differ between the anaesthetic methods?
Participants, scheduled for total hip, total knee and unicomartmental knee arthroplasty, will be randomized to recieve spinal anaesthesia or general anaesthesia in relation to surgery. At 6 hours postoperatively a physiotherapist will conduct a 5-meter walking test to evaluate whether the participant can be safely mobilized.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical and radiological hip or knee osteoarthritis meeting the indications for primary total hip, total knee, or unicompartmental knee arthroplasty.
* ≥18 years of age.
* Able to speak and understand Danish
* Able to give informed consent and must be cognitively intact.
Exclusion Criteria:
* Lives in an institution.
* Uses walking aid such as a walker or a wheelchair.
* Terminal illness.
* Has contraindications for either general or spinal anaesthesia.
* Has objections to receiving either general or spinal anaesthesia.
* Requires anxiolytics as premedication prior to anaesthesia.
* Traumatic aetiology as a basis for surgical indication.
* Altered pain perception and / or neurologic affection due to diabetes or other disorders.
* Daily preoperative use of opioids \> 30 mg of morphine milligram equivalents (MME).
* Standard primary arthroplasty procedure is evaluated not to be suitable.
* Women considered fertile but without sufficient birth control.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ability to be mobilsed safely within 6 hours of surgery