Spinal Anaesthesia vs. General Anaesthesia for THA, TKA and UKA (RCT SAGA)

Anders Troelsen

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis, Hip; Osteoarthritis, Knee

Treatments: Drug: General anaesthesia; Drug: Spinal anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05706844

2022-501221-21-00

Details and patient eligibility

About

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.

Enrollment: 222 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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222 participants in 2 patient groups

Spinal Anaesthesia (SA)

Experimental group

Description:

Patients undergoing total hip, total knee or unicompartmental knee arthroplasty are anaesthetized using: Plain or heavy Bupivacaine hydrochloride 10 mg (2 mL)

Treatment:

Drug: Spinal anesthesia

General Anaesthesia (GA)

Experimental group

Description:

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)

Treatment:

Drug: General anaesthesia