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Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks - NCT00923598-44195(Clinical Trial 298466)



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City:  Cleveland
State:  
OH
Zip Code: 44195
Conditions: Total Knee Arthroplasty - Knee Pain
Purpose: This is a randomized, observer-masked, controlled study. Subjects will be patients undergoing bilateral total knee arthroplasty (TKA). One side (left or right) will be randomized to one of two treatment groups: a postoperative ropivacaine concentration of 0.1% or 0.4%. The contralateral side will receive the other possible ropivacaine concentration of 0.1% or 0.4%. The basal rate and patient-controlled bolus volume will depend upon the treatment group, but the total dose of local anesthetic is the same for each. For the duration of the study, all patients will receive the current usual and customary analgesics for bilateral TKA patients. All patients will receive a ropivacaine perineural infusions initiated in the operating room and continued until at least the afternoon of postoperative day (POD) 2, as well as oral acetaminophen, a sustained-release oral opioid; and celecoxib. Rescue opioid and route of administration will be determined by pain severity using a Numeric Rating Scale of 0-10, with 0 equal to no pain and 10 being the worst imaginable pain.
Study summary: The investigators propose to test the null hypothesis that differing concentrations of ropivacaine (0.1% vs. 0.4%) at an equal total dose has no impact on quadriceps muscle strength during a continuous femoral nerve block following total knee arthroplasty (TKA). These results will help define the optimal concentration of local anesthetic used for continuous peripheral nerve blocks.
Criteria: Inclusion Criteria: - Primary, bilateral TKA - Age 18 years or older - Postoperative analgesic pain includes bilateral continuous femoral nerve blocks Exclusion Criteria: - Chronic, high-dose opioid use - History of opioid abuse - Any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles - Pregnancy - Incarceration
Study is available at: The Cleveland Clinic, Main Campus
Cleveland, OH 44195
United States

Primary Contact:
Daniel I Sessler, M.D.
Email: sessled@ccf.org
Phone: 216-444-4900

Secondary Contact:
Daniel I Sessler, M.D.
Email: sessled@ccf.org
Phone: 216-444-4900
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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