Autologous Blood Transfusion After Local Infiltration
1 other identifier
observational
52
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 3, 2012
CompletedFirst Posted
Study publicly available on registry
April 12, 2012
CompletedApril 10, 2015
April 1, 2015
1 month
April 3, 2012
April 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Concentrations of ropivacaine in serum
Concentrations of ropivacaine in serum before and after autologous blood transfusion will be analyzed.
6 hours
Secondary Outcomes (1)
Analysis of ECG and pulse rate
6 hours
Study Arms (2)
Total knee arthroplasty
25 consecutive patients diagnosed for total knee arthroplasty.
Total hip arthroplasty
27 patients diagnosed for total hip arthroplasty.
Interventions
Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg
Eligibility Criteria
Primary care clinic.
You may qualify if:
- Clinical diagnosis for hip arthroplasty
- Clinical diagnosis for knee arthroplasty
You may not qualify if:
- Patients \< 18 years
- Lack of informed consent
- Inability to read/understand Danish
- Bilateral diagnosis
- Cancer diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vendsyssel Hospital, Frederikshavn, Aalborg Hospital, Aarhus University
Aalborg, Denmark
Biospecimen
Venous blood to collect an analysis of total ropivacaine concentrations.
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ole Simonsen, M.D.
Northern Orthopaedic Department, Aalborg University Hospital, Denmark
- STUDY CHAIR
Sten Rasmussen, M.D.
Northern Orthopaedic Division, Aalborg University Hospital, Denmark
- STUDY CHAIR
Bjarne B. Dencker, M.D.
Department of Anaesthesiology, Aalborg University Hospital, Denmark
- STUDY CHAIR
Torben Breindahl, M.D.
Department of Clinical Biochemistry, Vendsyssel Hospital, Aarhus University, Denmark
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2012
First Posted
April 12, 2012
Study Start
March 1, 2010
Primary Completion
April 1, 2010
Study Completion
June 1, 2010
Last Updated
April 10, 2015
Record last verified: 2015-04