Spinal Anaesthesia vs. General Anaesthesia for THA, TKA and UKA

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Trial on Spinal Anaesthesia vs. General Anaesthesia (SAGA) on Recovery After Total Hip, Total Knee, and Unicompartmental Knee Arthroplasty

Conditions
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Osteoarthritis, Hip, Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Spinal anesthesia
* Drug: General anaesthesia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Anaesthesia (SA)<br>Patients undergoing total hip, total knee or unicompartmental knee arthroplasty are anaesthetized using: Plain or heavy Bupivacaine hydrochloride 10 mg (2 mL) | Drug: Spinal anesthesia<br>* plain or heavy Bupivacaine hydrochloride 10 mg (2 mL) injected in the spinal canal<br>* Other names: Spinal anaesthesia;|
| Experimental: General Anaesthesia (GA)<br>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) | Drug: General anaesthesia<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within 6 hours postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 
| Dizziness 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. | 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. | 
| 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. | 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. | 
| Quality of Recovery-15 score | Four hours postoperatively on the day of surgery and at 10:00 on the following postoperative days, as long as admitted, participants will answer the QoR-15 questionnaire regarding postoperative and postanaesthetic recovery. | 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. | 
| Vital signs - systolic blood pressure | Systolic blood pressure (mmHg). | 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. | 
| Vital signs - diastolic blood pressure | Diastolic blood pressure (mmHg). | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip arthroplasty, Knee arthroplasty, Unicompartmental knee arthroplasty, General anaesthesia, Spinal anaesthesia, Hip osteoarthritis, Knee osteoarthritis, Fast-track surger