Autologous Blood Transfusion After Local Infiltration

Completed

• Conditions: Total Hip Arthroplasty; Total Knee Arthroplasty
• Interventions: Drug: Autologous blood transfusion with ropivacaine

• Registration Number: NCT01576263
• Lead Sponsor: Northern Orthopaedic Division, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2010-04
• Study Completion: 2010-06
• Study First Submitted: 2012-04-03
• Study First Submitted QC: 2012-04-11
• Study First Posted: 2012-04-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total knee arthroplasty	Autologous blood transfusion with ropivacaine	25 consecutive patients diagnosed for total knee arthroplasty.
Total hip arthroplasty	Autologous blood transfusion with ropivacaine	27 patients diagnosed for total hip arthroplasty.

Primary Outcome Measures

Name	Time	Method
Concentrations of ropivacaine in serum	6 hours	Concentrations of ropivacaine in serum before and after autologous blood transfusion will be analyzed.

Secondary Outcome Measures

Name	Time	Method
Analysis of ECG and pulse rate	6 hours	ECG, pulse rate and blood pressure will be analyzed in proportion to concentrations of serum before and after autologous blood transfusion

Trial Locations

Locations (1)

Vendsyssel Hospital, Frederikshavn, Aalborg Hospital, Aarhus University; 🇩🇰 Aalborg, Denmark