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

NCT ID: NCT05706844

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2025-04-06

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.

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Spinal Anaesthesia (SA)

Patients undergoing total hip, total knee or unicompartmental knee arthroplasty are anaesthetized using:

Plain or heavy Bupivacaine hydrochloride 10 mg (2 mL)

Group Type: EXPERIMENTAL

Spinal anesthesia

Intervention Type: DRUG

plain or heavy Bupivacaine hydrochloride 10 mg (2 mL) injected in the spinal canal

General Anaesthesia (GA)

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)

Group Type: EXPERIMENTAL

General anaesthesia

Intervention Type: DRUG

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

Interventions

Spinal anesthesia

plain or heavy Bupivacaine hydrochloride 10 mg (2 mL) injected in the spinal canal

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Spinal anaesthesia

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vejle Hospital

OTHER

Sponsor Role: collaborator

Anders Troelsen

OTHER

Sponsor Role: lead

Responsible Party

Anders Troelsen

Professor, consultant physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anders Troelsen, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

Christian Bredgaard Jensen

Hvidovre, , Denmark

Vejle Hospital

Vejle, , Denmark

Countries

Denmark

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2022-501221-21-00

Identifier Type: -

Identifier Source: org_study_id