Osteoarthritis, HipPhase 4RCT SAGANCT05706844
Spinal Anaesthesia vs. General Anaesthesia for THA, TKA and UKA
A Phase 4 study testing Spinal anesthesia and General anaesthesia in people with Osteoarthritis, Hip and Osteoarthritis, Knee, run by Anders Troelsen at 2 sites in Denmark.
Trial summary
The goal of this randomized clinical trial is to investigate the postoperative recovery following hip and knee arthroplasty procedures depending on the use of either spinal anaesthesia (SA) or general anaesthesia (GA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip, Osteoarthritis, Knee
- What is being tested?
- Spinal anesthesia and General anaesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 2 sitesDenmark
- Study dates
- 6 Mar 2023to 6 Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and radiological hip or knee osteoarthritis meeting the indications for primary total hip, total knee, or unicompartmental knee arthroplasty.
- ≥18 years of age.
- Able to speak and understand Danish
- Able to give informed consent and must be cognitively intact.
Who cannot join
- Lives in an institution.
- Uses walking aid such as a walker or a wheelchair.
- Terminal illness.
- Has contraindications for either general or spinal anaesthesia.
- Has objections to receiving either general or spinal anaesthesia.
- Requires anxiolytics as premedication prior to anaesthesia.
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- Traumatic aetiology as a basis for surgical indication.
- Altered pain perception and / or neurologic affection due to diabetes or other disorders.
- Daily preoperative use of opioids > 30 mg of morphine milligram equivalents (MME).
- Standard primary arthroplasty procedure is evaluated not to be suitable.
- Women considered fertile but without sufficient birth control.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Christian Bredgaard Jensen
Hvidovre, 2650
Vejle Hospital
Vejle, 7100
About this study
Official title: Randomized Trial on Spinal Anaesthesia vs. General Anaesthesia (SAGA) on Recovery After Total Hip, Total Knee, and Unicompartmental Knee Arthroplasty
The goal of this randomized clinical trial is to investigate the postoperative recovery following hip and knee arthroplasty procedures depending on the use of either spinal anaesthesia (SA) or general anaesthesia (GA).
The main questions are:
Read more
- Are more patients able to be safely mobilized within 6 hours postoperatively when using GA compared to SA?
- Does postoperative pain, nausea and vomiting, dizzyness, occurence of delirium and urinary retention differ between the anaesthetic methods?
Participants, scheduled for total hip, total knee and unicomartmental knee arthroplasty, will be randomized to recieve spinal anaesthesia or general anaesthesia in relation to surgery. At 6 hours postoperatively a physiotherapist will conduct a 5-meter walking test to evaluate whether the participant can be safely mobilized.
- Conditions
- Osteoarthritis, Hip, Osteoarthritis, Knee
- Being tested
- Spinal anesthesia, General anaesthesia
- Keywords
- Hip arthroplasty, Knee arthroplasty, Unicompartmental knee arthroplasty, General anaesthesia, Spinal anaesthesia, Hip osteoarthritis, Knee osteoarthritis, Fast-track surger
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesiaDrug
Also called Spinal anaesthesia
plain or heavy Bupivacaine hydrochloride 10 mg (2 mL) injected in the spinal canal
General anaesthesiaDrug
Propofol (induction: 1.0-2.0 mg/kg. infusion: 3-5 mg/kg/hour) + Remifentanil (induction: 3-5 mcg/kg, infusion: 0.5 mcg/kg/min) given intravenously
| Study group | Role | What they receive |
|---|---|---|
| Spinal Anaesthesia (SA) | Experimental | Patients undergoing total hip, total knee or unicompartmental knee arthroplasty are anaesthetized using:
Plain or heavy Bupivacaine hydrochloride 10 mg (2 mL) Receives: Drug: Spinal anesthesia |
| General Anaesthesia (GA) | Experimental | Patients undergoing total hip, total knee or unicompartmental knee arthroplasty are anaesthetized using:
Propofol (induction: 1.0-2.0 mg/kg. infusion: 3-5 mg/kg/hour) + Remifentanil (induction: 3-5 mcg/kg, infusion: 0.5 mcg/kg/min) Receives: Drug: General anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to be mobilsed safely within 6 hours of surgery
5-meter walking test where a physiotherapist evaluates whether the participant can be safely mobilized within 6 hours of surgery.
Measured: within 6 hours postoperatively.
Secondary outcomes (4)
Fulfilment of discharge criteria
Dichotomous (Yes or No)
Measured: On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted.
Pain score
Will be recorded during rest and 5-m walk using participant evaluated NRS of 0 to 10, with 10 being worst pain/dizziness/nausea imaginable. This will be recorded at 4 and 6 hours post-operatively on the day of surgery and at 10:00 and 18:00 on the following postoperative days.
Measured: On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted.
Opioid use in Morphine Milligram Equivilents within the first 6 hours of surgery
Cumulated opioid use in Morphine Milligram Equivalents.
Measured: On the day of surgery: Within the first 6 hours after surgery.
Nausea Score
Will be recorded during rest and 5-m walk using participant evaluated NRS of 0 to 10, with 10 being worst pain/dizziness/nausea imaginable. This will be recorded at 4 and 6 hours post-operatively on the day of surgery and at 10:00 and 18:00 on the following postoperative days.
Measured: On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start6 Mar 2023
- Primary completion6 Apr 2025
- Study completion6 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each of the three arthroplasty procedures are investigated in a 2-arm randomised trial: Total hip arthroplasty - either spinal anaesthesia or general anaesthesia. Total knee arthroplasty - either spinal anaesthesia or general anaesthesia. Unicompartmental knee arthroplasty - either spinal anaesthesia or general anaesthesia.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anders Troelsen
- Sponsor type
- University, hospital or other
- Collaborators
- Vejle Hospital
- Responsible party
- Sponsor-investigator, Anders Troelsen, Hvidovre University Hospital
- Investigators
- Anders Troelsen, MD, DMSc, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706844
- Sponsor's protocol ID
- 2022-501221-21-00
- Acronym
- RCT SAGA
- Status last verified
- Sep 2026
- First submitted
- 11 Jan 2023
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial on Spinal Anaesthesia vs. General Anaesthesia (SAGA) on Recovery After Total Hip, Total Knee, and Unicompartmental Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05706844
- Acronym / sponsor ID
- RCT SAGA / 2022-501221-21-00
- Conditions
- Osteoarthritis, Hip, Osteoarthritis, Knee
- Keywords
- Hip arthroplasty, Knee arthroplasty, Unicompartmental knee arthroplasty, General anaesthesia, Spinal anaesthesia, Hip osteoarthritis, Knee osteoarthritis, Fast-track surger
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Anders TroelsenUniversity, hospital or other
- Collaborators
- Vejle Hospital
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 6 Apr 2025 (actual)
- Study completion
- 6 Apr 2025 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized clinical trial is to investigate the postoperative recovery following hip and knee arthroplasty procedures depending on the use of either spinal anaesthesia (SA) or general anaesthesia (GA).
The main questions are:
- Are more patients able to be safely mobilized within 6 hours postoperatively when using GA compared to SA?
- Does postoperative pain, nausea and vomiting, dizzyness, occurence of delirium and urinary retention differ between the anaesthetic methods?
Participants, scheduled for total hip, total knee and unicomartmental knee arthroplasty, will be randomized to recieve spinal anaesthesia or general anaesthesia in relation to surgery. At 6 hours postoperatively a physiotherapist will conduct a 5-meter walking test to evaluate whether the participant can be safely mobilized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each of the three arthroplasty procedures are investigated in a 2-arm randomised trial: Total hip arthroplasty - either spinal anaesthesia or general anaesthesia. Total knee arthroplasty - either spinal anaesthesia or general anaesthesia. Unicompartmental knee arthroplasty - either spinal anaesthesia or general anaesthesia.
| Arm | Type | Receives |
|---|---|---|
| Spinal Anaesthesia (SA) | Experimental | Drug: Spinal anesthesiaPatients undergoing total hip, total knee or unicompartmental knee arthroplasty are anaesthetized using: Plain or heavy Bupivacaine hydrochloride 10 mg (2 mL) |
| General Anaesthesia (GA) | Experimental | Drug: General anaesthesiaPatients undergoing total hip, total knee or unicompartmental knee arthroplasty are anaesthetized using: Propofol (induction: 1.0-2.0 mg/kg. infusion: 3-5 mg/kg/hour) + Remifentanil (induction: 3-5 mcg/kg, infusion: 0.5 mcg/kg/min) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical and radiological hip or knee osteoarthritis meeting the indications for primary total hip, total knee, or unicompartmental knee arthroplasty.
- ≥18 years of age.
- Able to speak and understand Danish
- Able to give informed consent and must be cognitively intact.
Key exclusion criteria (11 listed)
- Lives in an institution.
- Uses walking aid such as a walker or a wheelchair.
- Terminal illness.
- Has contraindications for either general or spinal anaesthesia.
- Has objections to receiving either general or spinal anaesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anesthesiaAlso: Spinal anaesthesiaplain or heavy Bupivacaine hydrochloride 10 mg (2 mL) injected in the spinal canal | Drug | Spinal Anaesthesia (SA) |
| General anaesthesiaPropofol (induction: 1.0-2.0 mg/kg. infusion: 3-5 mg/kg/hour) + Remifentanil (induction: 3-5 mcg/kg, infusion: 0.5 mcg/kg/min) given intravenously | Drug | General Anaesthesia (GA) |
Primary outcome
Ability to be mobilsed safely within 6 hours of surgery
Time frame: within 6 hours postoperatively.
5-meter walking test where a physiotherapist evaluates whether the participant can be safely mobilized within 6 hours of surgery.
4 secondary outcomes
Fulfilment of discharge criteria
Time frame: On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted.
Pain score
Time frame: On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted.
Opioid use in Morphine Milligram Equivilents within the first 6 hours of surgery
Time frame: On the day of surgery: Within the first 6 hours after surgery.
Nausea Score
Time frame: On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis, Hip
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
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PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Troelsen, MD, DMSc principal investigator
Hvidovre University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spinal anesthesia and General anaesthesia in people with Osteoarthritis, Hip and Osteoarthritis, Knee, run by Anders Troelsen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to be mobilsed safely within 6 hours of surgery (time frame: within 6 hours postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.