Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02658149
• Other study ID #: 2015-422
• Status: Completed
• Phase: Phase 4
• Start date: May 2016
• Est. completion date: June 2, 2017

Study information

• Verified date: April 2018
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2, 2017
• Est. primary completion date: May 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty
• Osteoarthritis

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
• Epinephrine
0.15 mg Epinephrine are injected as part of the drug "cocktail"
• Morphine
4 mg Morphine are injected as part of the drug "cocktail"
• Ketorolac Tromethamine
30 mg morphine are injected as part of the drug "cocktail"
• Ropivacaine
30 mL 0.5% Ropivicaine are injected as part of the drug "cocktail"

Locations

Country	Name	City	State
United States	Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score at 3 Hours	Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain	3 hours postoperative
Secondary	Pain Score at 3-24 Hours	Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain	measured once during time frame 3 hours-24 hours postoperative
Secondary	Pain Score at 24-48 Hours	Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain	measured once during time froma 24-48 hours postoperative
Secondary	Opioid Usage In-hospital at 24 Hours	Total amount of opioids used per patient (measured with Morphine Equivalent Units)	24 hours postoperatively
Secondary	Opioid Usage In-hospital at 48 Hours	Total amount of opioids used per patient (measured with Morphine Equivalent Units)	48 hours postoperatively