Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty

NCT02658149 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2015-422
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis; Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Pain Score at 3 Hours

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

  3 hours postoperative

Secondary Outcomes (4)

• Pain Score at 3-24 Hours

  measured once during time frame 3 hours-24 hours postoperative

• Pain Score at 24-48 Hours

  measured once during time froma 24-48 hours postoperative

• Opioid Usage In-hospital at 24 Hours

  24 hours postoperatively

• Opioid Usage In-hospital at 48 Hours

  48 hours postoperatively

Study Arms (2)

Psoas Compartment Block

EXPERIMENTAL

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

Periarticular Local Anesthetic

ACTIVE COMPARATOR

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

Ropivacaine with NaCl DRUG

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

Psoas Compartment Block

Epinephrine DRUG

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

Also known as: adrenaline

Periarticular Local Anesthetic

Morphine DRUG

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

Periarticular Local Anesthetic

Ketorolac Tromethamine DRUG

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

Also known as: Toradol

Periarticular Local Anesthetic

Ropivacaine DRUG

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

Also known as: Naropin

Periarticular Local Anesthetic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Ropivacaine; Epinephrine; Morphine; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring

Limitations and Caveats

Limitations of this study include single surgeon and single institution data, which affects generalizability of results.

Results Point of Contact

• Title: Dr. James Verner
• Organization: Beaumont Health

jverner1@aol.com

1(248)551-9722

Study Officials

• James Verner, MD

  William Beaumont Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 18, 2016
• Study Start: May 1, 2016
• Primary Completion: May 11, 2017
• Study Completion: June 2, 2017
• Last Updated: May 9, 2018
• Results First Posted: April 9, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)