Status:
COMPLETED
Peripheral Nerve Blocks vs Periarticular Local Anesthetic Injection for Total Knee Arthroplasty (TKA)
Lead Sponsor:
Mayo Clinic
Conditions:
Total Knee Arthroplasty
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to find a better way to make patients comfortable after their knee surgery. The investigators compared three ways of providing pain relief, either by use of a nerve block ...
Eligibility Criteria
Inclusion
- Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
- Patients presenting for unilateral primary total knee replacement.
- No focal neurologic deficit of the surgical lower extremity.
- Cognitively intact with the ability to sign informed consent
Exclusion
- Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
- History of long term use of daily opioids (\>1 months) with oral morphine equivalent (OME) \>5mg/day.
- Body mass index (BMI) \> 40 kg/m2
- Allergies to medications used in this study such as: fentanyl, hydromorphone, ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, OxyContin, tramadol, ondansetron, droperidol, or dexamethasone, celecoxib
- Major systemic medical problems such as:
- Severe renal disorder defined as glomerular filtration rate (GFR) \<50 units/m2
- Cardiovascular disorders defined as congestive heart failure (CHF) New York Heart Association (NYHA) class III-IV
- Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), fatty liver, chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver.
- Impaired cognitive function or inability to understand the study protocol
- Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy in the operative extremity, coagulopathy \[platelets \< 100,000, International Normalized Ratio (INR) \>1.5\], refusal, etc.).
- Previous contralateral knee replacement managed with regional or periarticular injection
- Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota
- Pregnancy or breast feeding (women of child-bearing potential, must have a negative pregnancy test)
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT02223364
Start Date
July 1 2014
End Date
July 1 2016
Last Update
August 31 2017
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905