Overview

Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular

Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
0
Participant gender:
All
Summary
Total hip arthroplasty is a one of the most commonly performed surgical procedures with increasing numbers anticipated over the next several decades. The purpose of this study was to find a better way to make patients comfortable after their hip surgery. Three different ways of providing pain relief were compared, a peripheral nerve block in the lower back outside of the spinal space (using bupivacaine, a numbing medicine), or injections around the hip joint with one of two different medicines, either Ropivacaine or Liposomal Bupivacaine (Exparel®).
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Mayo Clinic
Treatments:
Bupivacaine
Epinephrine
Ketorolac
Ropivacaine
Criteria
Inclusion Criteria:

1. Adult patients with an American Society of Anesthesiologists (ASA) physiological
status I-III

2. Patients presenting for unilateral primary total hip arthroplasty

3. 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 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, tramadol,
ondansetron, droperidol, dexamethasone, celecoxib and OxyContin

5. Major systemic medical problems such as:

1. severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2

2. cardiovascular disorders defined as Congestive Heart Failure (CHF) New York Heart
Association (NYHA) class III-IV

3. severe hepatic disorder defined as current or past diagnosis of acute/subacute
necrosis of 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 hip 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 breastfeeding (women of child-bearing potential will require a negative
pregnancy test)