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Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT02658149
Recruitment Status : Completed
First Posted : January 18, 2016
Results First Posted : April 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
James Verner, William Beaumont Hospitals

Study Description
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Brief Summary:
The primary objective of this study is to examine whether there is a difference in the level of resting pain following total hip arthroplasty with an anterior approach with use of a psoas compartment block versus a local periarticular anesthetic infiltration

Condition or disease Intervention/treatment Phase
Osteoarthritis Arthroplasty Drug: Ropivacaine with NaCl Drug: Epinephrine Drug: Morphine Drug: Ketorolac Tromethamine Drug: Ropivacaine Phase 4

Detailed Description:

A single-center, prospective, randomized clinical trial with a total of 100 patients. One orthopaedic adult reconstruction surgeon at Beaumont Hospital Royal Oak (JJV) will perform all surgeries. After the patient has consented they will be randomized to one of the following two groups:

  1. Psoas compartment block (n=50)
  2. Periarticular local anesthetic infiltration (n=50),

The patient will be blinded to the study group.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Psoas Compartment Block Versus Periarticular Local Anesthetic Infiltration for Pain Management for Total Hip Arthroplasty: A Prospective, Randomized Study
Study Start Date : May 2016
Actual Primary Completion Date : May 11, 2017
Actual Study Completion Date : June 2, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Psoas Compartment Block
After exposure anesthetic (Ropivacaine with NaCl) is introduced directly into the iliopsoas muscle, where it then spreads to the lumbar plexus (the nerves responsible for sensation around the surgical site).
 Drug: Ropivacaine with NaCl
50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment
Other Name: Naropin with NaCl
Active Comparator: Periarticular Local Anesthetic
An anesthetic "cocktail" of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues.
 Drug: Epinephrine
0.15 mg Epinephrine are injected as part of the drug "cocktail"
Other Name: adrenaline

Drug: Morphine
4 mg Morphine are injected as part of the drug "cocktail"

Drug: Ketorolac Tromethamine
30 mg morphine are injected as part of the drug "cocktail"
Other Name: Toradol

Drug: Ropivacaine
30 mL 0.5% Ropivicaine are injected as part of the drug "cocktail"
Other Name: Naropin


Outcome Measures
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Primary Outcome Measures :
  1. Pain Score at 3 Hours [ Time Frame: 3 hours postoperative ]
    Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain


Secondary Outcome Measures :
  1. Pain Score at 3-24 Hours [ Time Frame: measured once during time frame 3 hours-24 hours postoperative ]
    Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain

  2. Pain Score at 24-48 Hours [ Time Frame: measured once during time froma 24-48 hours postoperative ]
    Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain

  3. Opioid Usage In-hospital at 24 Hours [ Time Frame: 24 hours postoperatively ]
    Total amount of opioids used per patient (measured with Morphine Equivalent Units)

  4. Opioid Usage In-hospital at 48 Hours [ Time Frame: 48 hours postoperatively ]
    Total amount of opioids used per patient (measured with Morphine Equivalent Units)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing unilateral primary total hip arthroplasty by Dr. James Verner at Beaumont Hospital Royal Oak
  • Have a diagnosis of primary osteoarthritis (i.e. degenerative joint disease)
  • Surgical approach is anterior

Exclusion Criteria:

  • Minors (age less than 18 years)
  • Pregnant (surgically sterile, post-menopausal, or negative blood test)
  • Previous ipsilateral hip surgery
  • Lumbar instrumentation
  • Acute trauma
  • Rheumatoid arthritis
  • Avascular necrosis
  • Hip dysplasia
  • Known sensitivity, allergy, or contraindication to anesthetics being used in the study
  • Narcotic sensitivity
  • History of over 6 months of opioid dependency prior to surgery (excluding tramadol)
  • Peripheral neuropathy
  • Mental/cognitive impairment that would interfere with the patient's self-assessments of function, pain, or quality of life
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658149


Locations
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United States, Michigan
Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
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Principal Investigator: James Verner, MD William Beaumont Health
  Study Documents (Full-Text)

Documents provided by James Verner, William Beaumont Hospitals:
Informed Consent Form  [PDF] January 6, 2016
Study Protocol and Statistical Analysis Plan  [PDF] October 24, 2016

More Information
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Responsible Party: James Verner, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT02658149    
Other Study ID Numbers: 2015-422
First Posted: January 18, 2016    Key Record Dates
Results First Posted: April 9, 2018
Last Update Posted: May 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ketorolac
Ketorolac Tromethamine
Epinephrine
Morphine
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics