Anaesthesia for Hip and Knee Arthroplasty (SPIGA)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZealand University Hospital

About this trial

Beneficial and harmful effects of spinal versus general anaesthesia in patients undergoing hip and knee arthroplasty.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled for elective primary elective hip or knee arthroplasty, including unicompartmental knee

Disqualifiers

Scheduled for elective primary hip or knee arthroplasty, including unicompartmental knee

Age ≥ 18 years

Unable to communicate in written and/or spoken Danish Contraindications against either spinal or general anaesthesia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Spinal anaesthesia

    Procedure/Surgery

    Spinal anaesthesia according to local practice, including optional sedation with sedative-hypnotic pharmacological agents

  • General anaesthesia

    Procedure/Surgery

    General anaesthesia according to local practice

Treatment groups

3,000 Participants
are divided into 2 treatment groups
Group A: Spinal AnaesthesiaExperimental treatment 1 intervention
Group B: General AnaesthesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hospital-free days within 30 days

Defined as the number of days within the first 30 days following hip or knee arthroplasty surgery during which a participant is alive and not admitted to a hospital.

Time frame
Postoperative day 0-30

Secondary outcomes

1

Major complications

A major complication is defined as a major intra- or postoperative adverse event occurring from the initiation of anaesthesia through 30 days postoperatively.

Time frame
Postoperative day 0-30
2

Quality of Recovery

The Quality of Recovery-15 questionnaire (QoR-15) generates a composite score ranging from 0 to 150 across five domains (physical comfort, emotional state, physical independence, psychological support, and pain), with higher scores indicating better recovery.

Time frame
24 hours postoperatively

Other outcomes

1

Patient satisfaction with anaesthesia

Assessed 24 hours postoperatively by asking patients to rate their satisfaction on a numeric rating scale (NRS) from 0-10, where 0 indicates not satisfied at all/completely dissatisfied and 10 indicates extremely satisfied/fully satisfied.

Time frame
24 hours postoperatively
2

Health-related quality of life (EQ5D5L-VAS)

Evaluation of health-related quality of life using the EuroQol EQ5D5L- VAS questionnaire that adresses mobility, self-care, usual activities, pain/discomfort, anxiety/depression. The VAS is a vertical visual analogue score of self-rated health (EQ-VAS, 0 = "The worst health you can imagine" and 100 = "The best health you can imagine").

Time frame
Postoperative day 30
3

Number of unplanned hospital-visits

Defined as the number of any unplanned contact with the emergency department, outpatient clinic, or other hospital department.

Time frame
Postoperative day 0-30
4

Willingness to repeat the type of anaesthesia

Assessed at 24 hours postoperatively by asking participants whether they would choose the same type of anaesthesia again in case of future surgery.

Time frame
24 hours postoperatively

Locations

This trial has no locations.

Sponsors and contacts

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