Status:
COMPLETED
Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular
Lead Sponsor:
Mayo Clinic
Conditions:
Total Hip Arthroplasty
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
Total hip arthroplasty is associated with moderate to severe postoperative pain and an ideal clinical pathway for pain management has yet to be established. Multimodal pain management incorporating th...
Eligibility Criteria
Inclusion
- Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
- Patients presenting for unilateral primary total hip arthroplasty
- Patients 18 years of age and older
Exclusion
- 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, tramadol, ondansetron, droperidol, dexamethasone, celecoxib and OxyContin
- 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 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
- 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 hip replacement managed with regional or periarticular injection
- Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota
- Pregnancy or breastfeeding (women of child-bearing potential will require a negative pregnancy test)
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT02242201
Start Date
September 1 2014
End Date
September 1 2016
Last Update
April 19 2018
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905