Peripheral Nerve Blocks vs Periarticular Local Anesthetic Injection for Total Knee Arthroplasty (TKA)
Condition: Total Knee Arthroplasty
Intervention: Peripheral nerve blocks with Bupivacaine; Intra articular injection with Ropivacaine; Intra articular injection with liposomal bupivacaine
Intervention description: Subjects received Bupivacaine 0.5% preoperatively, then Bupivacaine 0.2% upon post anesthesia care unit (PACU) arrival via femoral nerve block, then Bupivacaine 0.25% via single-injection sciatic nerve.; Subjects received an intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Ropivacaine dose depended upon body weight: 50-74.9 kg: 200 mg, 75-99.9 kg: 300 mg, 100-125 kg: 400 mg.; Subjects received an intra articular injection with liposomal bupivacaine, a total volume of 120 mL injected in the periarticular structures by the surgeon. Patients weighing 50-125 kg received 266mg of Liposomal Bupivacaine.
Intervention MeSH terms: Bupivacaine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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 at the femoral and sciatic nerve areas, or with actual injections in the
      surgical joint area with one of two different medicines, either ropivacaine or liposomal
      bupivacaine (Exparel®). The hypothesis was that the nerve block at the femoral and sciatic
      nerve areas would result in lower pain scores and opioid consumption than either of the two
      injections in the surgical joint area.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patients with an American Society of Anesthesiologists (ASA) physiological
             status I-III

          2. Patients presenting for unilateral primary total knee replacement.

          3. No focal neurologic deficit of the surgical lower extremity.

          4. Cognitively intact with the ability to sign informed consent

        Exclusion Criteria:

          1. Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome

          2. History of long term use of daily opioids (>1 months) with oral morphine equivalent
             (OME) >5mg/day.

          3. Body mass index (BMI) > 40 kg/m2

          4. Allergies to medications used in this study such as: fentanyl, hydromorphone,
             ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, OxyContin,
             tramadol, ondansetron, droperidol, or dexamethasone, celecoxib

          5. 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.

          6. Impaired cognitive function or inability to understand the study protocol

          7. 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.).

          8. Previous contralateral knee replacement managed with regional or periarticular
             injection

          9. Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota

         10. Pregnancy or breast feeding (women of child-bearing potential, must have a negative
             pregnancy test)