Study on Spinal vs. General Anaesthesia with Ropivacaine Hydrochloride for Osteoarthritis Patients Undergoing Hip and Knee Replacement

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What is this study about?

This clinical trial is focused on studying the effects of different types of anesthesia on recovery after hip and knee replacements, specifically for patients with osteoarthritis of the hip and knee. The trial compares spinal anesthesia and general anesthesia to see which one helps patients recover better after surgery. The main goal is to find out if patients can safely and independently walk 5 meters within 6 hours after their surgery, depending on the type of anesthesia used.

During the study, participants will receive one of the two types of anesthesia. The medications involved in the trial include ropivacaine hydrochloride, ondansetron, propofol, tranexamic acid, sodium lactate, sufentanil, celecoxib, bupivacaine hydrochloride, remifentanil, calcium chloride, dexamethasone phosphate, paracetamol, sodium chloride, and potassium chloride. Some participants may receive a placebo. The study will monitor various aspects of recovery, such as pain levels, nausea, dizziness, and overall quality of recovery. It will also track any complications or hospital visits within 30 days after surgery.

The trial aims to provide valuable insights into which type of anesthesia might lead to a quicker and safer recovery for patients undergoing hip and knee replacement surgeries. This information could help improve patient care and outcomes in the future.

1 joining the trial

Upon joining the trial, you will be informed about the study’s purpose, procedures, and your role. You will be asked to provide informed consent, confirming your understanding and willingness to participate.

2 pre-surgery assessment

Before the surgery, a thorough assessment will be conducted to ensure you meet the eligibility criteria. This includes confirming your diagnosis of osteoarthritis of the hip or knee and your ability to communicate in Danish.

3 surgery preparation

You will be prepared for surgery, which involves either total hip, total knee, or unicompartmental knee replacement. The type of anesthesia you receive will be either spinal anesthesia or general anesthesia, as determined by the trial protocol.

4 anesthesia administration

During the surgery, you will receive medications such as ropivacaine hydrochloride or bupivacaine hydrochloride for spinal anesthesia, or propofol and remifentanil for general anesthesia. These medications will be administered through local injection or intravenous routes.

5 post-surgery recovery

After the surgery, your ability to walk 5 meters independently within 6 hours will be assessed. This is a primary goal of the trial to evaluate recovery based on the type of anesthesia used.

6 monitoring and follow-up

You will be monitored for various outcomes, including pain levels, nausea, dizziness, and overall recovery quality. Medications like ondansetron for nausea and paracetamol for pain may be administered as needed.

Additional assessments will include questionnaires and interviews to evaluate your recovery and any symptoms experienced post-surgery.

7 discharge and further observation

Once discharge criteria are met, you will be allowed to leave the hospital. Follow-up will continue for 30 days to monitor any complications, readmissions, or other health-related issues.

Who Can Join the Study?

Must have osteoarthritis of the hip or knee. Osteoarthritis is a joint condition that causes pain and stiffness.
Must be at least 18 years old.
Must be able to speak and understand Danish.
Must be able to give informed consent. This means you understand the study and agree to participate.
Must be cognitively intact, meaning you have no issues with memory or understanding.

Who Cannot Join the Study?

Patients who cannot walk 5 meters on their own or with a walking aid within 6 hours after surgery.
Patients who are not diagnosed with osteoarthritis of the hip or knee. Osteoarthritis is a condition that affects the joints, causing pain and stiffness.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Heblwsog Hnlzrkne	Hvidovre	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.11.2022

Trial locations

Investigated drugs:

Spinal Anaesthesia is a type of medication used to numb the lower part of the body during surgery. It is injected into the lower back, near the spinal cord, to block pain from the waist down. This type of anaesthesia allows patients to stay awake during the procedure, but they won’t feel any pain in the area being operated on. In this trial, spinal anaesthesia is being tested to see how well it helps patients recover after hip or knee surgery.

General Anaesthesia is a medication that makes a patient completely unconscious during surgery. It is usually given through a mask or an IV, and it affects the entire body, so the patient won’t feel any pain or be aware of the surgery. In this trial, general anaesthesia is being compared to spinal anaesthesia to see which one helps patients recover better after hip or knee surgery.

Investigated diseases:

Osteoarthritis

Osteoarthritis of the hip and knee – Osteoarthritis is a degenerative joint disease characterized by the breakdown of cartilage, which cushions the ends of bones in the joints. In the hip and knee, this condition leads to pain, stiffness, and swelling, making movement difficult. As the disease progresses, the cartilage wears away, causing bones to rub against each other, which can result in increased pain and reduced joint function. Over time, osteoarthritis can lead to the formation of bone spurs and a decrease in the joint space. This condition often affects older adults and can be influenced by factors such as age, weight, and previous joint injuries. The progression of osteoarthritis can vary, with some individuals experiencing a slow decline in joint function, while others may have more rapid deterioration.

Trial ID:

2022-501221-21-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Spinal vs. General Anaesthesia with Ropivacaine Hydrochloride for Osteoarthritis Patients Undergoing Hip and Knee Replacement

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?