Peripheral Nerve Blocks vs Periarticular Local Anesthetic Injection for TKA
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2014 |
| End Date: | October 2016 |
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
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).
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).
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)
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