Authorised Therapeutic use (Phase IV) Total knee and hip arthroplasties

General Anaesthesia vs Spinal anaesthesia: Patient outcomes and Success in outpatient primary total knee and hip arthroplasty.

EU CTIS ID: 2024-520127-89-00

What this study is testing

To determine whether the use of General anaesthesia (GA) compared to Spinal anaesthesia (SA) is associated with a higher frequency of successful same-day discharge in patients undergoing outpatient TKA and THA Successful same-day discharge is defined as: Discharge on the day of surgery, and No readmission within 48 hours of discharge.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1. The participant has given their written consent to participate in the trial.
  • 2. Planned for primary TKA or THA.
  • 3. Adults aged 18 to 80 years at time of written consent.
  • 4. ASA (American Society of Anesthesiologists) classification 1 or 2, or 3 without significant functional impairment.
  • 5. Scheduled start of surgery before 13:00.
  • 6. Ability to communicate in Swedish, ensuring understanding of informed consent and follow-up procedures.

You likely can't join if

  • 1. Indication for surgery other than degenerative or inflammatory joint diseases (e.g. fracture).
  • 10. Women of childbearing potential (i.e., those who are fertile, following menarche and until becoming post-menopausal, unless permanently sterile) a. Who are not willing to use a highly effective method of contraception judged by the investigator, from the time of signing the informed consent, OR b. Who has a positive pregnancy test at enrolment
  • 11. Individual unwilling or unable to receive either spinal or general anaesthesia
  • 12. Participation or recent participation in a clinical trial with an investigational medicinal product within 30 days.
  • 13. Previous participation in this trial.
  • 2. Body mass index (BMI) > 35 kg/m.
See the full eligibility criteria
Who can join
  • 1. The participant has given their written consent to participate in the trial.
  • 2. Planned for primary TKA or THA.
  • 3. Adults aged 18 to 80 years at time of written consent.
  • 4. ASA (American Society of Anesthesiologists) classification 1 or 2, or 3 without significant functional impairment.
  • 5. Scheduled start of surgery before 13:00.
  • 6. Ability to communicate in Swedish, ensuring understanding of informed consent and follow-up procedures.
What rules you out
  • 1. Indication for surgery other than degenerative or inflammatory joint diseases (e.g. fracture).
  • 10. Women of childbearing potential (i.e., those who are fertile, following menarche and until becoming post-menopausal, unless permanently sterile) a. Who are not willing to use a highly effective method of contraception judged by the investigator, from the time of signing the informed consent, OR b. Who has a positive pregnancy test at enrolment
  • 11. Individual unwilling or unable to receive either spinal or general anaesthesia
  • 12. Participation or recent participation in a clinical trial with an investigational medicinal product within 30 days.
  • 13. Previous participation in this trial.
  • 2. Body mass index (BMI) > 35 kg/m.
  • 3. Preoperative opioid use exceeding 20 mg oral morphine equivalents daily.
  • 4. Haemoglobin <120 g/L (sample no older than 3 months).
  • 5. Known bleeding disorders, including coagulopathies.
  • 6. Known allergies to investigational anaesthetic drugs (e.g., bupivacaine, remifentanil, or propofol).
  • 7. Neurological conditions with persistent motor or sensory deficits.
  • 8. Localised infections at the spinal injection site.
  • 9. Determined by the surgical or anaesthesia team to be unsuitable for trial participation and/or outpatient surgery.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.