Spinale anesthesie versus algemene anesthesie voor THA, TKA en UKA (RCT SAGA)
Gerandomiseerde studie over spinale anesthesie vs. algemene anesthesie (SAGA) over herstel na totale heup-, totale knie- en unicompartimentele knieartroplastiek
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Hvidovre, Denemarken, 2650
- Christian Bredgaard Jensen
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Vejle, Denemarken, 7100
- Vejle Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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) |
plain or heavy Bupivacaine hydrochloride 10 mg (2 mL) injected in the spinal canal
Andere namen:
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Experimenteel: 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) |
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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Ability to be mobilsed safely within 6 hours of surgery
Tijdsspanne: within 6 hours postoperatively.
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5-meter walking test where a physiotherapist evaluates whether the participant can be safely mobilized within 6 hours of surgery. |
within 6 hours postoperatively.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Fulfilment of discharge criteria
Tijdsspanne: 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.
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Dichotomous (Yes or No) |
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.
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Pain score
Tijdsspanne: 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.
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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.
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Opioid use in Morphine Milligram Equivilents within the first 6 hours of surgery
Tijdsspanne: On the day of surgery: Within the first 6 hours after surgery.
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Cumulated opioid use in Morphine Milligram Equivalents. |
On the day of surgery: Within the first 6 hours after surgery.
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Nausea Score
Tijdsspanne: 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.
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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.
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Vital signs - systolic blood pressure
Tijdsspanne: 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.
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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.
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Vital signs - diastolic blood pressure
Tijdsspanne: 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.
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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.
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Quality of Recovery-15 score
Tijdsspanne: 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.
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Four hours postoperatively on the day of surgery and at 10:00 on the following |
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.
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Anders Troelsen, MD, DMSc, Hvidovre University Hospital
Studie record data
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Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2022-501221-21-00
Plan Individuele Deelnemersgegevens (IPD)
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