Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Randomized trial on Spinal Anaesthesia vs. General Anaesthesia (SAGA) on recovery after total hip, total knee, and unicompartmental knee arthroplasty

This study, called SAGA, looks at people having hip or knee replacement surgery for painful arthritis. Doctors want to compare two ways of putting patients to sleep or numbing them: spinal anaesthesia (where medicine is put into the back to numb the lower body) versus general anaesthesia (where patients are fully asleep). The main goal is to find out which method allows patients to safely walk 5 metres (about 16 feet) within 6 hours after their operation, even if they need a walking aid. Researchers will also check things like pain levels, whether patients feel sick, and how quickly they can go home. This helps doctors understand the best way to help patients recover well after these common surgeries.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Hvidovre Hospital

Enrolment target

222

Start

17 Nov 2022

Osteoarthritis of the hip and knee

What is this study about?

Imagine you're having an operation to replace a hip or knee joint because of arthritis pain. Doctors need to give you medicine so you don't feel anything during the surgery. This study is trying to understand the best type of anaesthetic for these operations. They are comparing two main kinds: spinal anaesthesia, which numbs the lower half of your body while you might stay awake or be lightly sedated, and general anaesthesia, which makes you completely unconscious.

The main thing the doctors want to find out is which type of anaesthesia helps you get moving again more quickly. Specifically, they will be looking to see if you can safely walk 5 metres (that's about the length of a small car) within six hours after your surgery. This is important because getting up and moving soon after surgery can help with recovery.

But it's not just about walking! They'll also be checking other important things. This includes how much pain you feel and how many painkillers you need, if you feel sick or dizzy, how quickly you can go home, and your overall recovery. They will also look at whether you experience any problems like needing to go to the emergency room, or being readmitted to hospital within 30 days after your operation. This research helps improve care for people having these common surgeries.

Key takeaways

Compares spinal vs. general anaesthesia for hip/knee surgery.
Aims to find out which helps patients walk faster after surgery.
Also checks pain, sickness, and overall recovery.
For adults having hip, total knee, or partial knee replacement.
Helps improve care for future patients.
Participation involves extra monitoring during standard care.

Who may be eligible?

This study is for adults aged 18 and over, with no upper age limit. Both men and women can take part.

To be considered, you would need to be scheduled for a full hip replacement, a full knee replacement, or a partial knee replacement due to arthritis.

There will be other medical checks to make sure the study is safe for you, and that you fit all the necessary criteria to give reliable results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you scheduled for a hip replacement, total knee replacement, or partial knee replacement due to arthritis?
Are you able to provide consent (understand and agree) to take part?
Do you feel generally well enough to consider participating in a study alongside your surgery?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive either spinal anaesthesia or general anaesthesia for your hip or knee surgery, as decided by the study team. You would receive standard medications used during and after surgery, such as pain relief, anti-sickness medicines, and fluids. The study team would closely monitor your recovery in hospital, especially how soon you can safely walk 5 metres after your operation. They would also monitor your pain, any sickness, and your overall well-being. You would attend follow-up appointments and answer questionnaires about your health and recovery for up to 30 days after your surgery. There are no extra hospital visits beyond what is usually expected for this type of surgery; the study involves collecting extra information during your normal care.

Potential risks and benefits

Taking part in this study means you'll be helping doctors learn more about the best ways to provide anaesthesia for hip and knee replacements, which could benefit many patients in the future. You will also receive careful monitoring of your recovery. While the anaesthesia and medications used are standard procedures for these types of operations, there are always potential risks associated with any medical procedure, including anaesthesia. You'll be fully informed of these before deciding to participate. Remember, you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is the main goal of this study?

The main goal is to see if spinal anaesthesia or general anaesthesia helps people walk 5 metres within 6 hours after hip or knee surgery.

What kind of surgeries are included?

This study includes patients having total hip replacement, total knee replacement, or partial knee replacement surgery for arthritis.

Will I be awake during surgery if I have spinal anaesthesia?

With spinal anaesthesia, your lower body will be numb. You might be awake, or you might be given light sedation to make you drowsy or fall asleep during the operation.

Who can join this study?

Any adult aged 18 or older who is planned to have one of the included hip or knee surgeries for arthritis, regardless of gender.

How long will I be involved in the study?

You'll be closely monitored during your hospital stay, and information about your recovery will be collected for up to 30 days after your surgery.