Spinal Anaesthesia vs. General Anaesthesia for THA, TKA and UKA (RCT SAGA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip
• Intervention / Treatment: Drug: Spinal anesthesia; Drug: General anaesthesia

• Study Type: Interventional
• Enrollment (Anticipated): 222
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Christian Bredgaard Jensen, MD; Phone Number: +4520825950; Email: christian.bredgaard.jensen@regionh.dk
• Study Contact Backup: Name: Anders Troelsen, MD, DMSc; Phone Number: +4538626774; Email: anders.troelsen@regionh.dk

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Recruiting
    • Christian Bredgaard Jensen
    • Contact: Christian Bredgaard H Jensen, MD; Phone Number: 20825950; Email: christian.bredgaard.jensen@regionh.dk
    • Principal Investigator: Anders Troelsen, MD, DMSc
    • Principal Investigator: Kirill Gromov, MD, PhD
    • Sub-Investigator: Nicolai Bang Foss, MD, DMSc
  • Vejle, Denmark, 7100
    • Not yet recruiting
    • Vejle Hospital
    • Contact: Claus Varnum, MD, PhD; Phone Number: +4560698804; Email: Claus.Varnum@rsyd.dk
    • Principal Investigator: Claus Varnum, MD, PhD
    • Sub-Investigator: Lina Pleckaitiene, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: Spinal anesthesia; plain or heavy Bupivacaine hydrochloride 10 mg (2 mL) injected in the spinal canal; Other Names: Spinal anaesthesia
Experimental: 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)	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	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.	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.
Dizziness score	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.	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.
Nausea Score	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.	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.
Quality of Recovery-15 score	Four hours postoperatively on the day of surgery and at 10:00 on the following postoperative days, as long as admitted, participants will answer the QoR-15 questionnaire regarding postoperative and postanaesthetic recovery.	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.
Vital signs - systolic blood pressure	Systolic blood pressure (mmHg).	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.
Vital signs - diastolic blood pressure	Diastolic blood pressure (mmHg).	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.

Collaborators and Investigators

• Sponsor: Anders Troelsen
• Collaborators: Vejle Hospital
• Investigators: Principal Investigator: Anders Troelsen, MD, DMSc, Hvidovre University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Knee osteoarthritis; General anaesthesia; Knee arthroplasty; Hip arthroplasty; Unicompartmental knee arthroplasty; Spinal anaesthesia; Hip osteoarthritis; Fast-track surger
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2022-501221-21-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No