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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Oerebro Laen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

Decision date (initial)

2026-03-12

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-520127-89-00

ClinicalTrials.gov

NCT07334132

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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.

Secondary objectives 14

1. To compare the time from start of anaesthesia and to start of surgery between GA and SA.
2. To compare the time from the start of surgery to discharge from the postoperative recovery unit (Phase II) between GA and SA.
3. To compare the time from start of surgery to fulfilment of indicators for end phase III (intermediate recovery) as outlined in the protocol (table 4) between GA and SA.
4. To compare the time from the start of surgery to hospital discharge (Phase III) between GA and SA.
5. To compare the time from the start of surgery to first mobilisation with tolerable pain between GA and SA.
6. To evaluate and compare patient-reported quality of recovery (measured by QoR-15) between GA and SA from postoperative day (POD) 1 to POD 35.
7. To compare pain levels (measured by Numeric Rating Scale, NRS, Quality of recovery questions, and the use of opioids) between GA and SA.
8. To compare patient reported outcomes of surgical intervention between GA and SA.
9. To compare the use of analgesics during postoperative phases II–IV between GA and SA.
10. To assess the safety of SA and GA.
11. To assess the need for blood transfusion between GA and SA.
12. To explore patient-reported experiences of anaesthesia and postoperative care through semi-structured interviews.
13. To conduct a health economic evaluation comparing GA and SA in terms of costs per quality-adjusted life year (QALY) gained.
14. To evaluate healthcare resource utilisation, medication costs, and productivity losses associated with each anaesthetic method.

Conditions and MedDRA coding

Total knee and hip arthroplasties

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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

Exclusion criteria 13

1. 1. Indication for surgery other than degenerative or inflammatory joint diseases (e.g. fracture).
2. 2. Body mass index (BMI) > 35 kg/m.
3. 3. Preoperative opioid use exceeding 20 mg oral morphine equivalents daily.
4. 4. Haemoglobin <120 g/L (sample no older than 3 months).
5. 5. Known bleeding disorders, including coagulopathies.
6. 6. Known allergies to investigational anaesthetic drugs (e.g., bupivacaine, remifentanil, or propofol).
7. 7. Neurological conditions with persistent motor or sensory deficits.
8. 8. Localised infections at the spinal injection site.
9. 9. Determined by the surgical or anaesthesia team to be unsuitable for trial participation and/or outpatient surgery.
10. 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. 11. Individual unwilling or unable to receive either spinal or general anaesthesia
12. 12. Participation or recent participation in a clinical trial with an investigational medicinal product within 30 days.
13. 13. Previous participation in this trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Successful same-day discharge, defined as: • The patient is discharged from the hospital on the same day as the surgery and, • the patient is not readmitted within 48 hours of discharge.

Secondary endpoints 16

1. Time from start of anaesthesia to start of surgery (Phase II).
2. Time from start of surgery to discharge from the postoperative recovery unit (Phase II).
3. Time from start of surgery to fulfilment of indicators for end phase III (intermediate recovery) as outlined in the protocol (table 4).
4. Time from start of surgery to discharge from hospital (Phase III).
5. Time from start of surgery to first successful mobilisation, assessed by the ability to walk with tolerable pain and ascend/descend stairs if applicable.
6. Use of analgesics (opioids converted to Oral morphine equivalents (OME)).
7. Patient-reported quality of recovery using the Swedish Version of Quality of Recovery - 15 (QoR-15) from postoperative day (POD) 1 to POD 35.
8. Pain levels measured using the Numeric Rating Scale (NRS) during the recovery period (postoperative until discharge to ward)
9. Knee injury and Osteoarthritis Outcome Score (KOOS) at baseline, 4 weeks, 6 months 12 months.
10. Hip disability and Osteoarthritis Outcome Score (HOOS), at baseline, 4 weeks, 6 months 12 months.
11. Use of analgesics (opioids converted to Oral morphine equivalents (OME)). Daily postoperative day 1-14, weekly day 15-35
12. Incidence, severity and frequency of adverse events (AEs) and serious adverse events (SAEs), until postoperative day 3.
13. Incidence and frequency of predefined adverse outcomes. (Table 1), until postoperative day 3.
14. Units of blood transfusion, until discharge from hospital
15. Key themes from patient-reported experiences of anaesthesia and postoperative care, gathered through semi-structured interviews conducted 14–60 days post-surgery.
16. Incremental cost-effectiveness ratios (ICERs) comparing costs and quality-adjusted life years (QALYs) gained between GA and SA.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Oerebro Laen

Sponsor organisation

Region Oerebro Laen

Address

Sodra Grev Rosengatan

City

Orebro

Postcode

701 85

Country

Sweden

Scientific contact point

Organisation

Region Oerebro Laen

Contact name

Kristofer Nilsson

Public contact point

Organisation

Region Oerebro Laen

Contact name

Kristofer Nilsson

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications