Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07334132
Eligibility Criteria:
Inclusion Criteria:
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 Anaesthesiologists) 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.
Exclusion Criteria:
1. Indication for surgery other than degenerative or inflammatory joint diseases (e.g. fracture).
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.
10. Women of childbearing potential (i.e., those who are fertile, following menarche and until becoming post-menopausal, unless permanently sterile)
1. 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
2. Who has a positive pregnancy test at enrolment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07334132
Study Brief:
Protocol Section:
NCT07334132