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

Sponsor

Anders Troelsen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05706844

Collaborator

Vejle Hospital (Other)

222

Enrollment

Locations

Arms

12.9

Anticipated Duration (Months)

111

Patients Per Site

8.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Hip Osteoarthritis, Knee	Drug: Spinal anesthesia Drug: General anaesthesia	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

222 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Each of the three arthroplasty procedures are investigated in a 2-arm randomised trial: Total hip arthroplasty - either spinal anaesthesia or general anaesthesia. Total knee arthroplasty - either spinal anaesthesia or general anaesthesia. Unicompartmental knee arthroplasty - either spinal anaesthesia or general anaesthesia.Each of the three arthroplasty procedures are investigated in a 2-arm randomised trial:Total hip arthroplasty - either spinal anaesthesia or general anaesthesia. Total knee arthroplasty - either spinal anaesthesia or general anaesthesia. Unicompartmental knee arthroplasty - either spinal anaesthesia or general anaesthesia.

Masking:

Single (Outcomes Assessor)

Masking Description:

Physcians and nurses in the surgical department are not able to be blinded. But outcome assesors (ie. physiotherapists, research personel) are not aware of the treatment allocation.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
Dizziness 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.
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.
Quality of Recovery-15 score [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 postoperative days, as long as admitted, participants will answer the QoR-15 questionnaire regarding postoperative and postanaesthetic recovery.
Vital signs - systolic blood pressure [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).
Vital signs - diastolic blood pressure [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.