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

Osteoarthritis, Knee Clinical Trial

— RCT SAGA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05706844
• Other study ID #: 2022-501221-21-00
• Status: Recruiting
• Phase: Phase 4
• Start date: March 6, 2023
• Est. completion date: March 2025

Study information

• Verified date: June 2024
• Source: Hvidovre University Hospital
• Contact: Christian Bredgaard Jensen, MD
• Phone: +4520825950
• Email: christian.bredgaard.jensen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 222
• Est. completion date: March 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Drug:
• Spinal anesthesia
plain or heavy Bupivacaine hydrochloride 10 mg (2 mL) injected in the spinal canal
• 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

Country	Name	City	State
Denmark	Christian Bredgaard Jensen	Hvidovre
Denmark	Vejle Hospital	Vejle

Sponsors (2)

Lead Sponsor	Collaborator
Anders Troelsen	Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.