NCT01576263|Completed
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Sponsor study identifier
observational
52
1 country
1
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2010
Actual (reported)Study Completion
June 2010
Actual (reported)Total knee and hip arthroplasty for osteoarthritis is performed on still broader indications even in elderly patients with previous or current medical conditions. Especially comorbidity like cardiovascular diseases and conditions with increased risk of bleeding or previous thrombo-embolic events are major challenges. To facilitate safe use of ropivacaine as an analgesic, information on the concentrations levels after autologous blood transfusion following local infiltration analgesia is very crucial. However, very limited data are available. To verify the safety of autologous blood transfusion, ropivacaine concentrations were studied in 52 patients undergoing either total knee arthroplasty or total hip arthroplasty.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
April 2010
Actual (reported)June 2010
Actual (reported)April 3, 2012
Actual (reported)April 12, 2012
Actual (reported)Concentrations of ropivacaine in serum
Concentrations of ropivacaine in serum before and after autologous blood transfusion will be analyzed.
6 hours
Analysis of ECG and pulse rate
6 hours
25 consecutive patients diagnosed for total knee arthroplasty.
27 patients diagnosed for total hip arthroplasty.
Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg
Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg.
Primary care clinic.
Vendsyssel Hospital, Frederikshavn, Aalborg Hospital, Aarhus University
Aalborg, Denmark
Venous blood to collect an analysis of total ropivacaine concentrations.
Ole Simonsen, M.D.
Northern Orthopaedic Department, Aalborg University Hospital, Denmark
Sten Rasmussen, M.D.
Northern Orthopaedic Division, Aalborg University Hospital, Denmark
Bjarne B. Dencker, M.D.
Department of Anaesthesiology, Aalborg University Hospital, Denmark
Torben Breindahl, M.D.
Department of Clinical Biochemistry, Vendsyssel Hospital, Aarhus University, Denmark
52 participants (actual enrollment reported by the registry).
First Submitted
April 3, 2012
First Posted
April 12, 2012
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
HAKA: Routine Follow-Up at 1 Year After Hip- or Knee Arthroplasty: Wasting Resources or Appropriate Healthcare?
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Primary Completion
April 2010
Actual (reported)Study Completion
June 2010
Actual (reported)Last Updated
April 10, 2015
Record last verified: 2015-04
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Source: ClinicalTrials.gov.
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