Skip to main content
OpenTrials
Completed

NCT Number: NCT05706844

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Christian Bredgaard Jensen, Hvidovre, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

spinal anesthesia

Drug

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

Other names: Spinal anaesthesia

General Anaesthesia

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

Primary outcomes

  1. Ability to be mobilsed safely within 6 hours of surgery

    Time frame: 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 outcomes

  1. Fulfilment of discharge criteria

    Time frame: 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)

  2. Pain score

    Time frame: 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.

  3. Opioid use in Morphine Milligram Equivilents within the first 6 hours of surgery

    Time frame: On the day of surgery: Within the first 6 hours after surgery.

    Cumulated opioid use in Morphine Milligram Equivalents.

  4. Nausea Score

    Time frame: 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.

Other outcomes

  1. Vital signs - systolic blood pressure

    Time frame: 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.

    Systolic blood pressure (mmHg).

  2. Vital signs - diastolic blood pressure

    Time frame: 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.

    Diastolic blood pressure (mmHg).

  3. Quality of Recovery-15 score

    Time frame: On the day of surgery: at 4 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00. This will be asses as long as the patient is admitted.

    Four hours postoperatively on the day of surgery and at 10:00 on the following

Sponsors and collaborators

Lead sponsor

Anders Troelsen

Other

Collaborators

  • Vejle Hospital

Registry information

Official study title

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

Acronym: RCT SAGA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2023
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.