Femoral Nerve Block Compared to Exparel in Total Knee Replacement
This trial is active, not recruiting.
|Treatments||exparel, femoral nerve block bupivacaine, toradol, morphine sulfate|
|Sponsor||The New England Baptist Hospital|
|Start date||January 2014|
|End date||February 2017|
|Trial size||312 participants|
|Trial identifier||NCT02473198, 463360|
The main objective of the study is to determine if intrarticular injection with liposomal bupivicaine (Exparel) provides better postoperative pain relief and functional outcome following total knee replacement (TKR) than the current standard New England Baptist Hospital regimen of femoral nerve block combined with intraarticular injection of a standard bupivicaine solution.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Pain Relief measured by VAS Questionnaire
time frame: One Year
Functional Ability measured by the KSS Questionnaire Score
time frame: One Year
Male or female participants from 18 years up to 73 years old.
Inclusion Criteria: • Patients between the ages of 18 - 73 who are undergoing primary, unilateral, Total Knee Replacement at the New England Baptist Hospital in Boston, Massachusetts are eligible to participate. Exclusion Criteria: - Patients with Revision or Complex Total Knee Replacements and are under the age of 18, or over the age of 73 will be excluded. - Patients with an ASA 4 level will be excluded. - Patients with a Body Mass Index of less than 20, and over 40, will be excluded. - Patients taking preoperative narcotics, patients with extreme sensitivity or allergy to narcotics or local anesthetics, and patients using opioid medications for at least 3 months leading up to surgery, will also be excluded.
|Official title||A Prospective Randomized Trial Comparing Femoral Nerve Black to Intraoperative Local Anesthetic Injection of Liposomal Bupivacaine (Exparel) in Total Knee Replacement|
|Principal investigator||Carl Talmo, MD|
|Description||A prospective, single blind study comparing femoral nerve blockade and intraarticular posterior capsular injection to interarticular injection of bupivicaine and liposomal bupivicaine (Exparel) alone.|
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