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Clinical Trials/NCT01576263
NCT01576263
Completed
Not Applicable

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

Northern Orthopaedic Division, Denmark1 site in 1 country52 target enrollmentMarch 2010

Overview

Phase
Not Applicable
Intervention
Autologous blood transfusion with ropivacaine
Conditions
Total Hip Arthroplasty
Sponsor
Northern Orthopaedic Division, Denmark
Enrollment
52
Locations
1
Primary Endpoint
Concentrations of ropivacaine in serum
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
June 2010
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Northern Orthopaedic Division, Denmark
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Total knee arthroplasty

25 consecutive patients diagnosed for total knee arthroplasty.

Intervention: Autologous blood transfusion with ropivacaine

Total hip arthroplasty

27 patients diagnosed for total hip arthroplasty.

Intervention: Autologous blood transfusion with ropivacaine

Outcomes

Primary Outcomes

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

  • Analysis of ECG and pulse rate(6 hours)

Study Sites (1)

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