Peripheral Nerve Blocks vs Periarticular Local Anesthetic Injection for TKA

Overview

About this study

The purpose of this study is to evaluate the hypothesis that the investigators current total joint regional anesthesia pathway of continuous femoral nerve block plus single-injection sciatic block with multimodal analgesia (MC1156-462rev0114) is more effective than two other pathways utilizing periarticular local anesthesia injections for numeric rating score (NRS) of pain with movement after total knee arthroplasty (TKA) on postoperative day 1 morning. The periarticular injections include one consisting of ropivacaine and the other consisting of liposomal bupivacaine (Exparel).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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
  5. Patients 18 years of age and older

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 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 CHF 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, 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, MN
  10. Pregnancy or breast feeding (women of child-bearing potential, must have a negative pregnancy test)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Sandra Kopp, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

International patient clinical studies questions