Autologous Blood Transfusion After Local Infiltration

April 9, 2015 updated by: Northern Orthopaedic Division, Denmark

Autologous Blood Transfusion After Local Infiltration Analgesia With Ropivacaine in Total Knee and Hip Arthroplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Vendsyssel Hospital, Frederikshavn, Aalborg Hospital, Aarhus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic.

Description

Inclusion Criteria:

  • Clinical diagnosis for hip arthroplasty
  • Clinical diagnosis for knee arthroplasty

Exclusion Criteria:

  • Patients < 18 years
  • Lack of informed consent
  • Inability to read/understand Danish
  • Bilateral diagnosis
  • Cancer diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Total knee arthroplasty
25 consecutive patients diagnosed for total knee arthroplasty.
Drug: Autologous blood transfusion with ropivacaine
Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg
Other Names:
  • No other names.
Drug: Autologous blood transfusion with ropivacaine
Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg.
Other Names:
  • No other names.
Total hip arthroplasty
27 patients diagnosed for total hip arthroplasty.
Drug: Autologous blood transfusion with ropivacaine
Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg
Other Names:
  • No other names.
Drug: Autologous blood transfusion with ropivacaine
Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg.
Other Names:
  • No other names.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentrations of ropivacaine in serum
Time Frame: 6 hours
Concentrations of ropivacaine in serum before and after autologous blood transfusion will be analyzed.
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of ECG and pulse rate
Time Frame: 6 hours
ECG, pulse rate and blood pressure will be analyzed in proportion to concentrations of serum before and after autologous blood transfusion
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Orthopaedic Division, Denmark

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

April 3, 2012

First Submitted That Met QC Criteria

April 11, 2012

First Posted (Estimate)

April 12, 2012

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20090061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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