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

Primary Purpose

Osteoarthritis, Hip, Osteoarthritis, Knee

Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Spinal anesthesia
General anaesthesia
Sponsored by
Anders Troelsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Hip arthroplasty, Knee arthroplasty, Unicompartmental knee arthroplasty, General anaesthesia, Spinal anaesthesia, Hip osteoarthritis, Knee osteoarthritis, Fast-track surger

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Christian Bredgaard JensenRecruiting
  • Vejle Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Spinal Anaesthesia (SA)

General Anaesthesia (GA)

Arm Description

Patients undergoing total hip, total knee or unicompartmental knee arthroplasty are anaesthetized using: Plain or heavy Bupivacaine hydrochloride 10 mg (2 mL)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Vital signs - systolic blood pressure
Systolic blood pressure (mmHg).
Vital signs - diastolic blood pressure
Diastolic blood pressure (mmHg).

Full Information

First Posted
January 11, 2023
Last Updated
March 27, 2023
Sponsor
Anders Troelsen
Collaborators
Vejle Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05706844
Brief Title
Spinal Anaesthesia vs. General Anaesthesia for THA, TKA and UKA
Acronym
RCT SAGA
Official Title
Randomized Trial on Spinal Anaesthesia vs. General Anaesthesia (SAGA) on Recovery After Total Hip, Total Knee, and Unicompartmental Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anders Troelsen
Collaborators
Vejle Hospital

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip, Osteoarthritis, Knee
Keywords
Hip arthroplasty, Knee arthroplasty, Unicompartmental knee arthroplasty, General anaesthesia, Spinal anaesthesia, Hip osteoarthritis, Knee osteoarthritis, Fast-track surger

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
222 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal Anaesthesia (SA)
Arm Type
Experimental
Arm Description
Patients undergoing total hip, total knee or unicompartmental knee arthroplasty are anaesthetized using: Plain or heavy Bupivacaine hydrochloride 10 mg (2 mL)
Arm Title
General Anaesthesia (GA)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Spinal anesthesia
Other Intervention Name(s)
Spinal anaesthesia
Intervention Description
plain or heavy Bupivacaine hydrochloride 10 mg (2 mL) injected in the spinal canal
Intervention Type
Drug
Intervention Name(s)
General anaesthesia
Intervention Description
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 Outcome Measure Information:
Title
Ability to be mobilsed safely within 6 hours of surgery
Description
5-meter walking test where a physiotherapist evaluates whether the participant can be safely mobilized within 6 hours of surgery.
Time Frame
within 6 hours postoperatively.
Secondary Outcome Measure Information:
Title
Pain score
Description
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.
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.
Title
Dizziness score
Description
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.
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.
Title
Nausea Score
Description
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.
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.
Title
Quality of Recovery-15 score
Description
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.
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.
Title
Vital signs - systolic blood pressure
Description
Systolic blood pressure (mmHg).
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.
Title
Vital signs - diastolic blood pressure
Description
Diastolic blood pressure (mmHg).
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Bredgaard Jensen, MD
Phone
+4520825950
Email
christian.bredgaard.jensen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Anders Troelsen, MD, DMSc
Phone
+4538626774
Email
anders.troelsen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Troelsen, MD, DMSc
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christian Bredgaard Jensen
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Bredgaard H Jensen, MD
Phone
20825950
Email
christian.bredgaard.jensen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Anders Troelsen, MD, DMSc
First Name & Middle Initial & Last Name & Degree
Kirill Gromov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Nicolai Bang Foss, MD, DMSc
Facility Name
Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claus Varnum, MD, PhD
Phone
+4560698804
Email
Claus.Varnum@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Claus Varnum, MD, PhD
First Name & Middle Initial & Last Name & Degree
Lina Pleckaitiene, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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