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OpenTrials
Completed

NCT Number: NCT01576263

Autologous Blood Transfusion After Local Infiltration

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.

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Key information

Conditions

Total Hip Arthroplasty Total Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vendsyssel Hospital, Frederikshavn, Aalborg Hospital, Aarhus University

Aalborg, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous blood transfusion with ropivacaine

Drug

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

Other names: No other names.

Primary outcomes

  1. Concentrations of ropivacaine in serum

    Time frame: 6 hours

    Concentrations of ropivacaine in serum before and after autologous blood transfusion will be analyzed.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 12, 2012
Registry last updated
Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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