Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-09-30

Brief Summary

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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®).

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Detailed Description

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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 the use of regional anesthesia for THA has led to decreased hospital length of stay, improved patient comfort, and enhanced patient satisfaction that is efficacious and cost-effective. This investigation compared multimodal total joint arthroplasty pathways with continuous lumbar plexus blockade versus two different periarticular injection mixtures to potentially determine an ideal perioperative analgesia pathway for THA.

Patients undergoing elective, unilateral primary total hip arthroplasty within a clinical pathway utilizing preemptive low-dose opioid and non-opioid medications for multimodal analgesia were randomized to one of three different intervention groups after informed consent was obtained: posterior lumbar plexus block (PNB), periarticular infiltration (PAI) with ropivacaine, ketorolac, and epinephrine, and PAI with liposomal bupivacaine, ketorolac, and epinephrine. The investigators hypothesized differences in the analgesia outcomes between the three intervention groups would provide for an evidenced-based clinical pathway to emerge as a result of this study.

Conditions

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Total Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PNB Bupivacaine

Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.

Group Type ACTIVE_COMPARATOR

PNB Bupivacaine

Intervention Type DRUG

Infusion

Epinephrine

Intervention Type DRUG

Injection, weight-based dosage of 100 mcg - 300 mcg

PAI Ropivacaine

Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.

Group Type ACTIVE_COMPARATOR

PAI Ropivacaine

Intervention Type DRUG

Injection

Epinephrine

Intervention Type DRUG

Injection, weight-based dosage of 100 mcg - 300 mcg

Ketorolac

Intervention Type DRUG

Injection, 30 mg

PAI liposomal bupivacaine

Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.

Group Type ACTIVE_COMPARATOR

PAI liposomal bupivacaine

Intervention Type DRUG

Injection

Epinephrine

Intervention Type DRUG

Injection, weight-based dosage of 100 mcg - 300 mcg

Ketorolac

Intervention Type DRUG

Injection, 30 mg

Interventions

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PNB Bupivacaine

Infusion

Intervention Type DRUG

PAI Ropivacaine

Injection

Intervention Type DRUG

PAI liposomal bupivacaine

Injection

Intervention Type DRUG

Epinephrine

Injection, weight-based dosage of 100 mcg - 300 mcg

Intervention Type DRUG

Ketorolac

Injection, 30 mg

Intervention Type DRUG

Other Intervention Names

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Marcaine Naropin Exparel Acuvail Acular

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes