Clinical trial NCT05706844: Spinal Anaesthesia vs. General Anaesthesia for THA, TKA and UKA
Official title: Randomized Trial on Spinal Anaesthesia vs. General Anaesthesia (SAGA) on Recovery After Total Hip, Total Knee, and Unicompartmental Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Hip
Osteoarthritis, Knee
Keywords: Hip arthroplasty
Knee arthroplasty
Unicompartmental knee arthroplasty
General anaesthesia
Spinal anaesthesia
Hip osteoarthritis
Knee osteoarthritis
Fast-track surger
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Vejle Hospital
First posted: 2023-01-31
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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).

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Ability to be mobilsed safely within 6 hours of surgery
timeFrame: within 6 hours postoperatively.
Secondary outcomes:
measure: Fulfilment of discharge criteria
timeFrame: 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.
measure: Pain score
timeFrame: 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.
measure: Opioid use in Morphine Milligram Equivilents within the first 6 hours of surgery
timeFrame: On the day of surgery: Within the first 6 hours after surgery.
measure: Nausea Score
timeFrame: 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.
Other outcomes:
measure: Vital signs - systolic blood pressure
timeFrame: 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.
measure: Vital signs - diastolic blood pressure
timeFrame: 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.
measure: Quality of Recovery-15 score
timeFrame: On the day of surgery: at 4 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00. This will be asses as long as the patient is admitted.
Locations:
city: Hvidovre
country: Denmark
facility: Christian Bredgaard Jensen
city: Vejle
country: Denmark
facility: Vejle Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Anders Troelsen, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: