Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

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

Registered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Administration of anaesthesia

    You will receive one of two types of anaesthesia, which is medicine used to prevent feeling pain during surgery.

    If general anaesthesia is used, you will receive an intravenous infusion, which is a liquid medicine delivered through a vein. This involves remifentanil at a dose of 10 mg and propofol at a dose of 3 g.

    If spinal anaesthesia is used, medicine is injected into the space around the spinal cord through an intrathecal injection. This involves bupivacaine at a dose of 10 mg, combined with sufentanil at 10 µg or fentanyl at 50 µg.

  2. Step 2

    Surgery and immediate recovery

    Once the anaesthesia has started, the surgery for the knee or hip replacement will begin.

    After the surgery, you will be monitored in a postoperative recovery unit until you are ready to be moved to a ward or discharged.

  3. Step 3

    Hospital discharge and short-term follow-up

    You will be monitored for discharge from the hospital, which is intended to occur on the same day as the surgery.

    The success of the discharge is measured by whether you are not readmitted to the hospital within 48 hours after leaving.

  4. Step 4

    Recovery monitoring

    During the recovery period, pain levels will be measured using a scale to check your comfort.

    The use of analgesics, which are medicines used to relieve pain, will be recorded daily from day 1 to day 14, and then weekly from day 15 to day 35.

    Any adverse events, which are unexpected or unwanted medical occurrences, will be monitored until the third day after surgery.

  5. Step 5

    Long-term follow-up

    Between day 1 and day 35 after surgery, you will report your quality of recovery.

    Specific scores regarding your knee or hip function and disability will be collected at 4 weeks, 6 months, and 12 months after the procedure.

    An interview regarding your experience with the anaesthesia and care may be conducted between 14 and 60 days after the surgery.

Who can join the trial?

6 criteria

  • 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 trial?

14 criteria

  • 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).
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • 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.

What is already known about the treatment

  • Remifentanil

    This medication is an opioid analgesic administered through a continuous intravenous infusion to provide rapid pain relief during surgery. It is widely used in clinical practice to manage intense pain by binding to specific receptors in the brain and spinal cord that control pain signals. As a short-acting opioid, it works quickly and wears off fast, making it ideal for controlled surgical settings.

  • Propofol

    This drug is an intravenous sedative used to induce and maintain sleep during medical procedures. It is a common tool in general anesthesia that works by increasing the activity of certain natural chemicals in the brain to produce a calming and sleepy effect. It is highly valued in modern medicine for its ability to allow patients to wake up quickly after a procedure.

  • Bupivacaine

    This is a local anesthetic typically administered through an injection into the spinal fluid to numb a specific area of the body. It is commonly used in spinal anesthesia to block pain signals from traveling to the brain by preventing nerve cells from communicating. This medication is a standard part of many surgical procedures to ensure patients do not feel pain during or after the operation.

  • Sufentanil

    This is a very potent opioid medication that is administered via injection into the spinal fluid for intense pain management. It is well-established in medical literature for providing deep pain relief by attaching to specific receptors in the nervous system to block pain messages. It is classified as a strong analgesic often used when high levels of pain control are required during surgery.

  • Fentanyl

    This medication is a powerful opioid used for pain relief and is administered through an injection into the spinal fluid. It is a standard treatment in anesthesia that works by interacting with the body's natural pain-relief system to stop pain signals from reaching the brain. It is widely recognized for its fast-acting nature and its effectiveness in managing severe pain during surgical procedures.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520127-89-00Protocol codeGASPSEstimated enrolment600 patientsSponsorRegion Oerebro Laen

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.