An interventional study of Spinal anaesthesia and General anaesthesia in Hip Arthroplasty, Knee Arthroplasty and Spinal Anesthesia, sponsored by Zealand University Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Zealand University Hospital · Not applicable, Interventional, and Treatment
Beneficial and harmful effects of spinal versus general anaesthesia in patients undergoing hip and knee arthroplasty.
Effective and safe anaesthesia is fundamental to perioperative care. Hip and knee arthroplasty are among the most frequently performed surgical procedures worldwide and are typically performed under either spinal or general anaesthesia. However, high-quality comparative evidence regarding the benefits and harms of these anaesthetic techniques remains limited and inconclusive.
Both techniques are associated with short- and long-term risks, including postoperative nausea and vomiting, hypotension, nerve injury, acute kidney injury, and respiratory and cardiovascular complications. In addition, they may differentially modulate the surgical stress response, potentially influencing postoperative recovery and risk of complications.
Objective:
To compare the benefits and harms of spinal versus general anaesthesia in patients undergoing hip or knee replacement. We hypothesise that spinal anaesthesia results in better postoperative outcomes than general anaesthesia.
Intervention:
Patients undergoing elective primary hip or knee arthroplasty will be randomised to receive either spinal or general anaesthesia, with randomisation stratified by participating centre.
Design:
The SPIGA trial is an investigator-initiated, multicentre, randomised, superiority clinical trial. Participants will be randomly allocated at a 1:1 ratio using a central, computer-generated randomisation sequence. A total sample size of 3000 participants was determined using simulation-based methods to provide at least 90% power to detect a prespecified minimally clinically important difference, corresponding to an increase of one hospital-free day in at least 10% of participants at a two-sided significance level of 0.05.
Planned sub-studies
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 114 across 766 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Zealand University Hospital is the lead sponsor of 236 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Spinal anaesthesia
Procedure: General anaesthesia
Spinal anaesthesia according to local practice, including optional sedation with sedative-hypnotic pharmacological agents
General anaesthesia according to local practice
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
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
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
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
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
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
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
Day-case discharge
Number of patients assessed as eligible for day-case surgery being discharged on the day of surgery.
Time frame: Postoperative day 0
No study locations are listed for this record.
Plan to share: Yes — Data will be published anonymised in accordance with ICMJE (International Committee of Medical Journal Editors) guidelines.
Supporting information: Study protocol, Statistical analysis plan
Time frame: The study protocol and statistical analysis plan will be available after they have been published.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Sep 2031, 59 months later.
Of 391 non-industry interventional studies with no phase under Postoperative Complications, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 44. This study's planned 59 months is above that.
Counting every sponsor, half of 395 studies reached it within 21 months; a quarter within 8 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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