Phase 4 N=165 Randomized Single-blind Treatment

Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular

Total Hip Arthroplasty

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View on ClinicalTrials.gov: NCT02242201 ↗

Enrolled (actual)

165

Serious AEs

0.0%

Results posted

Jan 2018

Primary outcome: Primary: Maximum Postoperative Pain Score — 3.0; 4.0; 3.0 units on a scale — p=0.033

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: PNB Bupivacaine (Drug); PAI Ropivacaine (Drug); PAI liposomal bupivacaine (Drug); Epinephrine (Drug); Ketorolac (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Postoperative Pain Score	3.0; 4.0; 3.0	0.033 sig
SECONDARY Total Opioid Consumption During Hospitalization	15; 15; 15; 10; 10; 10	0.948

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®).

Eligibility Criteria

Inclusion Criteria

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 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, tramadol, ondansetron, droperidol, dexamethasone, celecoxib and OxyContin
Major systemic medical problems such as:
severe renal disorder defined as glomerular filtration rate (GFR) 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)

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Data sourced from ClinicalTrials.gov (NCT02242201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.