Peripheral Nerve Blocks vs Periarticular Local Anesthetic Injection for Total Knee Arthroplasty (TKA)

Completed · Phase 4

Conditions studied: Total Knee Arthroplasty

In brief

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.

Key facts

Study ID

NCT02223364

Run by

Mayo Clinic

People needed

165

Starts

2014-07-01

Expected to finish

2016-07-01

Last updated by the study team

2017-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.