Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty

April 9, 2018 updated by: James Verner, William Beaumont Hospitals

Psoas Compartment Block Versus Periarticular Local Anesthetic Infiltration for Pain Management for Total Hip Arthroplasty: A Prospective, Randomized Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Toradol
Drug: Ropivacaine
30 mL 0.5% Ropivicaine are injected as part of the drug "cocktail"
Other Names:
  • Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score at 3 Hours
Time Frame: 3 hours postoperative
Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
3 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
measured once during time frame 3 hours-24 hours postoperative
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
measured once during time froma 24-48 hours postoperative
Opioid Usage In-hospital at 24 Hours
Time Frame: 24 hours postoperatively
Total amount of opioids used per patient (measured with Morphine Equivalent Units)
24 hours postoperatively
Opioid Usage In-hospital at 48 Hours
Time Frame: 48 hours postoperatively
Total amount of opioids used per patient (measured with Morphine Equivalent Units)
48 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Beaumont Hospitals

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

May 11, 2017

Study Completion (Actual)

June 2, 2017

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

January 15, 2016

First Posted (Estimate)

January 18, 2016

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-422

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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