Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty

NCT ID: NCT02658149

Last Updated: 2018-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-06-02

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.

Conditions

Osteoarthritis; Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Ropivacaine with NaCl

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Epinephrine

Intervention Type: DRUG

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

Morphine

Intervention Type: DRUG

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

Ketorolac Tromethamine

Intervention Type: DRUG

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

Ropivacaine

Intervention Type: DRUG

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

Interventions

Ropivacaine with NaCl

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

Intervention Type: DRUG

Epinephrine

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

Intervention Type: DRUG

Morphine

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

Intervention Type: DRUG

Ketorolac Tromethamine

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

Intervention Type: DRUG

Ropivacaine

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

Intervention Type: DRUG

Other Intervention Names

Naropin with NaCl; adrenaline; Toradol; Naropin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

James Verner

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Verner, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Health

Locations

Beaumont Hospital

Royal Oak, Michigan, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015-422

Identifier Type: -

Identifier Source: org_study_id