Autologous Blood Transfusion After Local Infiltration

NCT ID: NCT01576263

Last Updated: 2015-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Total Hip Arthroplasty Total Knee Arthroplasty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Total knee arthroplasty

25 consecutive patients diagnosed for total knee arthroplasty.

Autologous blood transfusion with ropivacaine

Intervention Type DRUG

Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg

Total hip arthroplasty

27 patients diagnosed for total hip arthroplasty.

Autologous blood transfusion with ropivacaine

Intervention Type DRUG

Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg.

Interventions

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Autologous blood transfusion with ropivacaine

Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg

Intervention Type DRUG

Autologous blood transfusion with ropivacaine

Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg.

Intervention Type DRUG

Other Intervention Names

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No other names. No other names.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northern Orthopaedic Division, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ole Simonsen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Northern Orthopaedic Department, Aalborg University Hospital, Denmark

Sten Rasmussen, M.D.

Role: STUDY_CHAIR

Northern Orthopaedic Division, Aalborg University Hospital, Denmark

Bjarne B. Dencker, M.D.

Role: STUDY_CHAIR

Department of Anaesthesiology, Aalborg University Hospital, Denmark

Torben Breindahl, M.D.

Role: STUDY_CHAIR

Department of Clinical Biochemistry, Vendsyssel Hospital, Aarhus University, Denmark

Locations

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Vendsyssel Hospital, Frederikshavn, Aalborg Hospital, Aarhus University

Aalborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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N-20090061

Identifier Type: -

Identifier Source: org_study_id

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