Clinical trial NCT02223364: Peripheral Nerve Blocks vs Periarticular Local Anesthetic Injection for Total Knee Arthroplasty (TKA)
Official title: Prospective, Randomized, Controlled Trial Comparing Continuous Femoral and Single Injection Sciatic Peripheral Nerve Blocks vs Periarticular Injection With Ropivacaine or Liposomal Bupivacaine (Exparel) on Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-08-22
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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)

Primary outcomes:
measure: Maximum Pain Post-Operative Day (POD) 1 (Morning)
timeFrame: Post-Operative Day 1, approximately 6 am to 12:00 pm
Secondary outcomes:
measure: Average Pain Post-Postanesthesia Care Unit (PACU)
timeFrame: Post-operative Day 0, approximately 12 pm to 12 am
measure: Maximum Pain Post-PACU
timeFrame: Post-operative Day 0, approximately 12 pm to 12 am
measure: Average Pain POD 1 (24 Hours)
timeFrame: POD 1, approximately 12 am to 12 am next day
measure: Maximum Pain POD 1 (24 Hours)
timeFrame: POD 1, approximately 12 am to 12 am next day
measure: Average Pain POD 2 (24 Hours)
timeFrame: POD 2, approximately 12 am to 12 am next day
measure: Maximum Pain POD 2 (24 Hours)
timeFrame: POD 2, approximately 12 am to 12 am next day
measure: Preoperative Daily Opioid Use
timeFrame: baseline
measure: Intraoperative Opioid Use
timeFrame: During the procedure, approximately 2 hours after start of the procedure
measure: PACU Opioid Use
timeFrame: Approximately 2 hours after entry in PACU
measure: POD 0 Post-PACU Opioid Use
timeFrame: POD 0, approximately 12 pm to 12 am
measure: POD 1 Opioid Use
timeFrame: POD 1, approximately 12 am to 12 am next day
measure: POD 2 Opioid Use
timeFrame: POD 2, approximately 12 am to 12 am next day
measure: Hospital Length of Stay
timeFrame: Approximately 3 days
measure: Balance Testing on Operative Leg Using Unipedal Stance Time
timeFrame: baseline, approximately 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sandra Kopp, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amundson AW, Johnson RL, Abdel MP, Mantilla CB, Panchamia JK, Taunton MJ, Kralovec ME, Hebl JR, Schroeder DR, Pagnano MW, Kopp SL. A Three-arm Randomized Clinical Trial Comparing Continuous Femoral Plus Single-injection Sciatic Peripheral Nerve Blocks versus Periarticular Injection with Ropivacaine or Liposomal Bupivacaine for Patients Undergoing Total Knee Arthroplasty. Anesthesiology. 2017 Jun;126(6):1139-1150. doi: 10.1097/ALN.0000000000001586.