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
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