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Completed

NCT Number: NCT02223364

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

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.

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Key information

Conditions

Total Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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)

Treatment and study plan

Peripheral nerve blocks with Bupivacaine

Drug

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.

Other names: Marcaine, Sensorcaine

Intra articular injection with Ropivacaine

Drug

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.

Other names: Naropin

Intra articular injection with liposomal bupivacaine

Drug

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.

Other names: Exparel

Primary outcomes

  1. Maximum Pain Post-Operative Day (POD) 1 (Morning)

    Time frame: Post-Operative Day 1, approximately 6 am to 12:00 pm

    Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.

Secondary outcomes

  1. Average Pain Post-Postanesthesia Care Unit (PACU)

    Time frame: Post-operative Day 0, approximately 12 pm to 12 am

    Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.

  2. Maximum Pain Post-PACU

    Time frame: Post-operative Day 0, approximately 12 pm to 12 am

    Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.

  3. Average Pain POD 1 (24 Hours)

    Time frame: POD 1, approximately 12 am to 12 am next day

    Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.

  4. Maximum Pain POD 1 (24 Hours)

    Time frame: POD 1, approximately 12 am to 12 am next day

    Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.

  5. Average Pain POD 2 (24 Hours)

    Time frame: POD 2, approximately 12 am to 12 am next day

    Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.

  6. Maximum Pain POD 2 (24 Hours)

    Time frame: POD 2, approximately 12 am to 12 am next day

    Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.

  7. Preoperative Daily Opioid Use

    Time frame: baseline

    Opioid consumption will be documented in the patient electronic medical record by the nursing staff caring for the patient.

  8. Intraoperative Opioid Use

    Time frame: During the procedure, approximately 2 hours after start of the procedure

    Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.

  9. PACU Opioid Use

    Time frame: Approximately 2 hours after entry in PACU

    Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.

  10. POD 0 Post-PACU Opioid Use

    Time frame: POD 0, approximately 12 pm to 12 am

    Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.

  11. POD 1 Opioid Use

    Time frame: POD 1, approximately 12 am to 12 am next day

    Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.

  12. POD 2 Opioid Use

    Time frame: POD 2, approximately 12 am to 12 am next day

    Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.

  13. Hospital Length of Stay

    Time frame: Approximately 3 days

    The hospital length of stay was measured from the date of admittance until the date of discharge.

  14. Balance Testing on Operative Leg Using Unipedal Stance Time

    Time frame: baseline, approximately 12 weeks

    In order to measure clinical balance, unipedal stance time (UST) was collected as an indicator of balance and fall risk. Timing (in seconds) began upon withdrawal of support and continued until the uplifted foot returned to the floor, the subject required support, or if the subject reached a time limit of 30 seconds. The best performance of three repetitions was recorded for analysis. Normative values for the UST are available. A UST threshold of 30 seconds yields a sensitivity of 95% and a specificity of 58% in identifying those with a history of falls. The first five seconds of unipedal stance is indicative of dynamic balance; inability to maintain unipedal stance for five seconds is a significant predictor of injurious falls.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 22, 2014
Registry last updated
Aug 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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