Comparing Remifentanil, Propofol, Bupivacaine, Sufentanil, and Fentanyl for patients undergoing outpatient total knee and hip replacement surgery

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What is this study about?

This study is designed to compare the effects of different types of anesthesia during Total Knee Arthroplasty and Total Hip Arthroplasty, which are surgical procedures used to replace a damaged knee or hip joint. The research aims to determine if General Anaesthesia, where a patient is completely asleep, or Spinal Anaesthesia, which numbs a specific part of the body, leads to a higher rate of successful discharge on the same day as the surgery. Participants will receive one of these two methods of anesthesia to undergo their joint replacement procedures.

The group receiving General Anaesthesia will be given remifentanil hydrochloride and propofol through an intravenous infusion, which is a method of delivering medication directly into a vein. The group receiving Spinal Anaesthesia will receive medications through intrathecal use, which means the medicine is injected into the fluid surrounding the spinal cord. The medications used for this method include bupivacaine hydrochloride, epinephrine, sufentanil citrate, or fentanyl citrate.

During the course of the study, researchers will observe the time it takes for patients to move from the start of anesthesia through different stages of recovery. Information will be gathered regarding the use of analgesics, which are pain-relieving medicines, and the levels of pain experienced after surgery. The study will also track the ability of patients to move around, such as walking, and will monitor any unwanted side effects or the need for blood transfusions to ensure patient safety and recovery quality.

Who Can Join the Study?

  • The person must provide written consent, which means signing a formal document that shows they agree to take part in the study.
  • The person must be scheduled for a primary TKA or THA, which refers to a first-time surgery to replace a damaged knee or hip joint with an artificial one.
  • The person must be an adult between the ages of 18 and 80 years old.
  • The person must have an ASA classification of 1 or 2, or a 3 without significant functional impairment. The ASA classification is a system used by doctors to measure how healthy a patient is before surgery.
  • The surgery must be scheduled to start before 13:00.
  • The person must be able to communicate in Swedish to ensure they understand the study details and the steps to follow after the procedure.

Who Cannot Join the Study?

  • You cannot join if your surgery is being done for a reason other than joint disease, such as a broken bone, which is known as a fracture.
  • Women who are able to become pregnant cannot participate unless they use a very reliable form of contraception (methods used to prevent pregnancy) or if they are permanently unable to have children.
  • You are not eligible if you have a positive pregnancy test at the time you join the study.
  • You cannot participate if you are unwilling or unable to receive either spinal anaesthesia (numbing only the lower part of the body) or general anaesthesia (being completely asleep during surgery).
  • You are excluded if you have taken an experimental medicine as part of a different clinical trial within the last 30 days.
  • You cannot participate if you have already taken part in this specific study before.
  • You are not eligible if your Body Mass Index, which is a measure of body fat based on your height and weight, is greater than 35.
  • You cannot join if you use more than a certain amount of opioids (strong pain relief medicines) every day.
  • You are excluded if your haemoglobin levels (a protein in your red blood cells that carries oxygen) are lower than 120 g/L.
  • You cannot participate if you have known bleeding disorders or coagulopathies, which are conditions that prevent your blood from clotting properly.
  • You are not eligible if you have known allergies to specific drugs used for numbing or sleep during surgery, such as bupivacaine, remifentanil, or propofol.
  • You cannot join if you have neurological conditions, which are problems with the brain or nervous system, that cause lasting issues with movement or feeling.
  • You are excluded if you have an infection at the specific spot on your back where the spinal injection would be given.
  • You cannot participate if your surgeon or the medical team decides you are not suitable for this study or for outpatient surgery (surgery where you go home the same day).

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
Region Oerebro Laen Orebro Sweden
Region Skane Hassleholm Hospital Hassleholm Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Not yet recruiting
01.04.2026

Trial locations

Remifentanil is a medication used to provide pain relief, typically administered through an IV during surgery to help keep a patient comfortable.

Propofol is a sedative medication used to induce sleep and keep a patient unconscious during a surgical procedure.

Bupivacaine is a local anesthetic used in spinal anesthesia to numb a specific area of the body, preventing the sensation of pain during surgery.

Sufentanil is a potent pain-relieving medication used as part of anesthesia to manage pain during or after a medical procedure.

Fentanyl is a strong pain medication used during surgery to help manage pain and ensure the patient does not feel discomfort.

Osteoarthritis – This is a condition where the protective tissue at the ends of the bones wears down over time. It most commonly affects the joints in the knees and hips. As the tissue thins, the bones may rub against each other, leading to joint discomfort and stiffness. The condition typically progresses gradually, often becoming more noticeable with age or increased activity. Over time, the joint structure may change, affecting movement and function.

Trial ID:
2024-520127-89-00
Protocol code:
GASPS
NCT ID:
NCT07334132
Trial Phase:
Therapeutic confirmatory (Phase III)

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