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CompletedNCT02658149Updated May 9, 2018Results posted

Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty

A Phase 4 interventional study of Ropivacaine with NaCl and Epinephrine in Osteoarthritis and Arthroplasty, sponsored by William Beaumont Hospitals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-09.

Sponsored by William Beaumont Hospitals · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Osteoarthritis
  • Arthroplasty

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03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 100 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

William Beaumont Hospitals is the lead sponsor of 111 studies on the registry; none are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 30 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

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).

    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.

    Drug: Epinephrine · Drug: Morphine · Drug: Ketorolac Tromethamine · Drug: Ropivacaine

Interventions

  • DrugRopivacaine with NaCl

    50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment

    Also known as: Naropin with NaCl

  • DrugEpinephrine

    0.15 mg Epinephrine are injected as part of the drug "cocktail"

    Also known as: adrenaline

  • DrugMorphine

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

  • DrugKetorolac Tromethamine

    30 mg morphine are injected as part of the drug "cocktail"

    Also known as: Toradol

  • DrugRopivacaine

    30 mL 0.5% Ropivicaine are injected as part of the drug "cocktail"

    Also known as: Naropin

06

What researchers measure

Primary outcomes

  1. Pain Score at 3 Hours

    Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain

    Time frame: 3 hours postoperative

Secondary outcomes

  1. Pain Score at 3-24 Hours

    Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain

    Time frame: measured once during time frame 3 hours-24 hours postoperative

  2. Pain Score at 24-48 Hours

    Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain

    Time frame: measured once during time froma 24-48 hours postoperative

  3. Opioid Usage In-hospital at 24 Hours

    Total amount of opioids used per patient (measured with Morphine Equivalent Units)

    Time frame: 24 hours postoperatively

  4. Opioid Usage In-hospital at 48 Hours

    Total amount of opioids used per patient (measured with Morphine Equivalent Units)

    Time frame: 48 hours postoperatively

07

Results

Posted Apr 9, 2018
Limitations and caveats
Limitations of this study include single surgeon and single institution data, which affects generalizability of results.

Participant flow

Participant flow — Overall Study
MilestonePsoas Compartment BlockPeriarticular Local Anesthetic
Started5050
Completed4950
Not completed10
Withdrew: Physician decision10

Outcome measures

PrimaryPain Score at 3 Hours

Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain

Time frame:
3 hours postoperative
Reported as:
Mean · units on a scale
Pain Score at 3 Hours
units on a scalePsoas Compartment BlockPeriarticular Local Anesthetic
Pain Score at 3 Hours4.0 ± 2.22.9 ± 2.2
Statistical analysis
  • Psoas Compartment Block vs Periarticular Local Anesthetic · Wilcoxon (Mann-Whitney) · p = 0.036
SecondaryPain Score at 3-24 Hours

Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain

Time frame:
measured once during time frame 3 hours-24 hours postoperative
Reported as:
Mean · units on a scale
Pain Score at 3-24 Hours
units on a scalePsoas Compartment BlockPeriarticular Local Anesthetic
Pain Score at 3-24 Hours1.9 ± 1.71.3 ± 1.4
Statistical analysis
  • Psoas Compartment Block vs Periarticular Local Anesthetic · Wilcoxon (Mann-Whitney) · p = 0.204
SecondaryPain Score at 24-48 Hours

Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain

Time frame:
measured once during time froma 24-48 hours postoperative
Reported as:
Mean · units on a scale
Pain Score at 24-48 Hours
units on a scalePsoas Compartment BlockPeriarticular Local Anesthetic
Pain Score at 24-48 Hours1.9 ± 1.71.7 ± 1.7
Statistical analysis
  • Psoas Compartment Block vs Periarticular Local Anesthetic · Wilcoxon (Mann-Whitney) · p = 1.0
SecondaryOpioid Usage In-hospital at 24 Hours

Total amount of opioids used per patient (measured with Morphine Equivalent Units)

Time frame:
24 hours postoperatively
Reported as:
Mean · Morphine Equivalent Units (Oral)
Opioid Usage In-hospital at 24 Hours
Morphine Equivalent Units (Oral)Psoas Compartment BlockPeriarticular Local Anesthetic
Opioid Usage In-hospital at 24 Hours19.5 ± 12.816.7 ± 13.6
Statistical analysis
  • Psoas Compartment Block vs Periarticular Local Anesthetic · t-test, 2 sided · p = 0.741
SecondaryOpioid Usage In-hospital at 48 Hours

Total amount of opioids used per patient (measured with Morphine Equivalent Units)

Time frame:
48 hours postoperatively
Reported as:
Mean · Morphine Equivalent Units (Oral)
Opioid Usage In-hospital at 48 Hours
Morphine Equivalent Units (Oral)Psoas Compartment BlockPeriarticular Local Anesthetic
Opioid Usage In-hospital at 48 Hours22.3 ± 16.820.8 ± 16.4
Statistical analysis
  • Psoas Compartment Block vs Periarticular Local Anesthetic · t-test, 2 sided · p = 1.0

Adverse events

Collected over 3 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Psoas Compartment Block0/49 (0%)0/49 (0%)5/49 (10.2%)
Periarticular Local Anesthetic0/50 (0%)0/50 (0%)1/50 (2%)
Most frequent other events
Most frequent other events
EventPsoas Compartment BlockPeriarticular Local Anesthetic
Prolonged transient numbnessNervous system disorders5/491/50

Baseline characteristics

Age, Continuous
Age, Continuous(years)Psoas Compartment BlockPeriarticular Local AnestheticTotal
Mean65 ± 868 ± 867 ± 8
Sex: Female, Male
Sex: Female, Male(Participants)Psoas Compartment BlockPeriarticular Local AnestheticTotal
Female262248
Male232851
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Psoas Compartment BlockPeriarticular Local AnestheticTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American246
White474693
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)Psoas Compartment BlockPeriarticular Local AnestheticTotal
United States495099
Preoperative Pain Score
Preoperative Pain Score(units on a scale)Psoas Compartment BlockPeriarticular Local AnestheticTotal
Mean3.4 ± 2.52.5 ± 2.62.9 ± 2.6
08

Study locations

1 site
  • Beaumont Hospital
    Royal Oak, Michigan 48073, United States
09

References and documents

Study documents

  • Informed consent form · Jan 6, 2016
  • Protocol and statistical analysis plan · Oct 24, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02658149
Lead sponsor
William Beaumont Hospitals
Responsible party
James Verner (MD, William Beaumont Hospitals) — Principal investigator
First posted
Jan 18, 2016
Start date
May 2016
Primary completion
May 11, 2017
Completion
Jun 2, 2017
Results posted
Apr 9, 2018
Last update
May 9, 2018

Study contacts

James Verner, MD
principal investigator · William Beaumont Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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