Autologous Blood Transfusion After Local Infiltration

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576263
• Other study ID #: N-20090061
• Status: Completed
• Phase: Phase 2
• First received: April 3, 2012
• Last updated: April 9, 2015
• Start date: March 2010
• Est. completion date: June 2010

Study information

• Verified date: April 2015
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Total Hip Arthroplasty
• Total Knee Arthroplasty

Intervention

Drug:
• Autologous blood transfusion with ropivacaine
Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg
• Autologous blood transfusion with ropivacaine
Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg.

Locations

Country	Name	City	State
Denmark	Vendsyssel Hospital, Frederikshavn, Aalborg Hospital, Aarhus University	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentrations of ropivacaine in serum	Concentrations of ropivacaine in serum before and after autologous blood transfusion will be analyzed.	6 hours	Yes
Secondary	Analysis of ECG and pulse rate	ECG, pulse rate and blood pressure will be analyzed in proportion to concentrations of serum before and after autologous blood transfusion	6 hours	Yes