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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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11 January 2021 |
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Main ID: |
EUCTR2016-002035-15-FI |
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Date of registration:
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12/05/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Outcome after total knee endoprosthesis under general or regional anesthesia, a randomized study
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Scientific title:
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Outcome after total knee arthroplasty under general or spinal anesthesia, a randomized study - Outcome after total knee arthroplasty under general or spinal anesthesia |
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Date of first enrolment:
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20/05/2016 |
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Target sample size:
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400 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002035-15 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Other medical treatment spinal vs general anaesthesia, Other surgical treatment: surgical tourniquet
Number of treatment arms in the trial: 4
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Finland
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Contacts
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Name:
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University Clinic
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Address:
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Sairaalakatu 1 (PO BOX 900)
00029
Vantaa
Finland |
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Telephone:
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+35894711 |
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Email:
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Affiliation:
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Helsinki University Central Hospital/ Peijas Hospital |
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Name:
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University Clinic
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Address:
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Sairaalakatu 1 (PO BOX 900)
00029
Vantaa
Finland |
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Telephone:
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+35894711 |
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Email:
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Affiliation:
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Helsinki University Central Hospital/ Peijas Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Inclusion: Informed consent, patients of 18-75-years, body mass index not more than 40kg/m2, ASA classification I-III
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
Exclusion criteria:
Patients with no long term strong opioid use, no contraindications for medications or anaesthesia used
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
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Patients undego total knee arthroplasty operation in general or spinal anaesthesia because of osteoarthritis, rheumatoid arthritis or other degenerative condition of the knee
MedDRA version: 19.0
Level: LLT
Classification code 10031174
Term: Osteoarthrosis
System Organ Class: 100000004859
MedDRA version: 19.0
Level: LLT
Classification code 10031158
Term: Osteo arthritis knees
System Organ Class: 100000004859
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Intervention(s)
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Trade Name: Bicain spinal
Pharmaceutical Form: Solution for injection
INN or Proposed INN: bupivacaine hydrochloride
Other descriptive name: BUPIVACAINE HYDROCHLORIDE
Trade Name: Propolipid
Pharmaceutical Form: Solution for injection
INN or Proposed INN: propofol
Other descriptive name: PROPOFOL
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Primary Outcome(s)
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Main Objective: The aim is to evaluate the best possible anaesthesia in association to total knee arthroplasty
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Timepoint(s) of evaluation of this end point: 24 hours
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Primary end point(s): Primary end point is acute pain (the amount of pain medication used within 24 hours after operation and pain by NRS.
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Secondary Objective: The aims are to find the patients at risk for complications e.g. chronic pain, as well as to find the best protocol for patient flow at the operational unit
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 24 hours to 12 months
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Secondary end point(s): Secondary end points: vomiting, nausea (NRS 1-10), chronic pain (BPI-SF), chronic pain risk index, knee function (OKS), quality of life (15D), patient satisfaction, complications, lenght of stay at the hospital, times at the operation unit
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 11/05/2016
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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