Autologous Blood Transfusion After Local Infiltration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01576263
First received: April 3, 2012
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Total Hip Arthroplasty
Total Knee Arthroplasty
Drug: Autologous blood transfusion with ropivacaine
Drug: Autologous blood transfusion with ropivacaine
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Autologous Blood Transfusion After Local Infiltration Analgesia With Ropivacaine in Total Knee and Hip Arthroplasty

Resource links provided by NLM:


Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • Concentrations of ropivacaine in serum [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
    Concentrations of ropivacaine in serum before and after autologous blood transfusion will be analyzed.


Secondary Outcome Measures:
  • Analysis of ECG and pulse rate [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
    ECG, pulse rate and blood pressure will be analyzed in proportion to concentrations of serum before and after autologous blood transfusion


Biospecimen Retention:   Samples Without DNA

Venous blood to collect an analysis of total ropivacaine concentrations.


Enrollment: 52
Study Start Date: March 2010
Study Completion Date: June 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Total knee arthroplasty
25 consecutive patients diagnosed for total knee arthroplasty.
Drug: Autologous blood transfusion with ropivacaine
Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg
Other Name: No other names.
Total hip arthroplasty
27 patients diagnosed for total hip arthroplasty.
Drug: Autologous blood transfusion with ropivacaine
Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg.
Other Name: No other names.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576263

Locations
Denmark
Vendsyssel Hospital, Frederikshavn, Aalborg Hospital, Aarhus University
Aalborg, Denmark
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Investigators
Principal Investigator: Ole Simonsen, M.D. Northern Orthopaedic Department, Aalborg University Hospital, Denmark
Study Chair: Sten Rasmussen, M.D. Northern Orthopaedic Division, Aalborg University Hospital, Denmark
Study Chair: Bjarne B. Dencker, M.D. Department of Anaesthesiology, Aalborg University Hospital, Denmark
Study Chair: Torben Breindahl, M.D. Department of Clinical Biochemistry, Vendsyssel Hospital, Aarhus University, Denmark
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01576263     History of Changes
Other Study ID Numbers: N-20090061
Study First Received: April 3, 2012
Last Updated: March 28, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
Anaesthesia
Infiltration
Blood transfusion
Autologous
Arthroplasty
Replacement
Ropivacaine

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014