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COMPLETED
NCT05706844
PHASE4

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

Sponsor: Anders Troelsen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

222

Start Date

2023-03-06

Completion Date

2025-04-06

Last Updated

2026-09-18

Healthy Volunteers

No

Interventions

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

Locations (2)

Christian Bredgaard Jensen

Hvidovre, Denmark

Vejle Hospital

Vejle, Denmark