Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty

• 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: William Beaumont Hospitals
• Information provided by (Responsible Party): James Verner, William Beaumont Hospitals

Tracking Information

• First Submitted Date: January 14, 2016
• First Posted Date: January 18, 2016
• Results First Submitted Date: February 16, 2018
• Results First Posted Date: April 9, 2018
• Last Update Posted Date: May 9, 2018
• Study Start Date: May 2016
• Actual Primary Completion Date: May 11, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: January 15, 2016): Pain Score [ Time Frame: 3 hours postoperatively ]

Current Secondary Outcome Measures (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 (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: Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Osteoarthritis
• Arthroplasty

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 15, 2016): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2, 2017
• Actual Primary Completion Date: May 11, 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02658149
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: James Verner, William Beaumont Hospitals
• Study Sponsor: William Beaumont Hospitals
• Collaborators: Not Provided

Investigators

• Principal Investigator: James Verner, MD; William Beaumont Health

• PRS Account: William Beaumont Hospitals
• Verification Date: April 2018