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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

Tracking Information
First Submitted Date  ICMJE January 14, 2016
First Posted Date  ICMJE January 18, 2016
Results First Submitted Date  ICMJE February 16, 2018
Results First Posted Date  ICMJE April 9, 2018
Last Update Posted Date May 9, 2018
Study Start Date  ICMJE May 2016
Actual Primary Completion Date May 11, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
Pain Score at 3 Hours [ Time Frame: 3 hours postoperative ]
Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2016)
Pain Score [ Time Frame: 3 hours postoperatively ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
  • 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
  • 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
  • Opioid Usage In-hospital at 24 Hours [ Time Frame: 24 hours postoperatively ]
    Total amount of opioids used per patient (measured with Morphine Equivalent Units)
  • Opioid Usage In-hospital at 48 Hours [ Time Frame: 48 hours postoperatively ]
    Total amount of opioids used per patient (measured with Morphine Equivalent Units)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2016)
Opioid usage in-hospital [ Time Frame: 24 hours and 24-48 hours postoperatively ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty
Official Title  ICMJE Psoas Compartment Block Versus Periarticular Local Anesthetic Infiltration for Pain Management for Total Hip Arthroplasty: A Prospective, Randomized Study
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Arthroplasty
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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).
    Intervention: Drug: Ropivacaine 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.
    Interventions:
    • Drug: Epinephrine
    • Drug: Morphine
    • Drug: Ketorolac Tromethamine
    • Drug: Ropivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2, 2017
Actual Primary Completion Date May 11, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02658149
Other Study ID Numbers  ICMJE 2015-422
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party James Verner, William Beaumont Hospitals
Study Sponsor  ICMJE William Beaumont Hospitals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Verner, MD William Beaumont Health
PRS Account William Beaumont Hospitals
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP