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

Phase 4

Completed

• Conditions: Osteoarthritis, Hip; Osteoarthritis, Knee
• Interventions: Drug: General anaesthesia; Drug: Spinal anesthesia

• Registration Number: NCT05706844
• Lead Sponsor: Anders Troelsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-01-31
• Study Start: 2023-03-06
• Primary Completion: 2025-04-06
• Study Completion: 2025-04-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General Anaesthesia (GA)	General anaesthesia	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)
Spinal Anaesthesia (SA)	Spinal anesthesia	Patients undergoing total hip, total knee or unicompartmental knee arthroplasty are anaesthetized using: Plain or heavy Bupivacaine hydrochloride 10 mg (2 mL)

Primary Outcome Measures

Name	Time	Method
Ability to be mobilsed safely within 6 hours of surgery	within 6 hours postoperatively.	5-meter walking test where a physiotherapist evaluates whether the participant can be safely mobilized within 6 hours of surgery.

Secondary Outcome Measures

Name	Time	Method
Fulfilment of discharge criteria	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.	Dichotomous (Yes or No)
Pain score	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.	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.
Opioid use in Morphine Milligram Equivilents within the first 6 hours of surgery	On the day of surgery: Within the first 6 hours after surgery.	Cumulated opioid use in Morphine Milligram Equivalents.
Nausea Score	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.	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.

Trial Locations

Locations (2)

Christian Bredgaard Jensen; 🇩🇰 Hvidovre, Denmark

Vejle Hospital; 🇩🇰 Vejle, Denmark