NCT05706844

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Anders Troelsen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Hip
• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Spinal anesthesia	plain or heavy Bupivacaine hydrochloride 10 mg (2 mL) injected in the spinal canal
DRUG	General anaesthesia	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

Timeline

• Start date: 2023-03-06
• Primary completion: 2025-04-06
• Completion: 2025-04-06
• First posted: 2023-01-31
• Last updated: 2025-05-04

Locations

2 sites across 1 country: Denmark