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Completed

NCT Number: NCT02658149

Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty

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

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Key information

Conditions

Osteoarthritis Arthritis Arthroplasty Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

About this study

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:

  • Psoas compartment block (n=50)
  • Periarticular local anesthetic infiltration (n=50),

The patient will be blinded to the study group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Naropin with NaCl

Epinephrine

Drug

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

Other names: adrenaline

Morphine

Drug

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

Ketorolac Tromethamine

Drug

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

Other names: Toradol

Ropivacaine

Drug

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

Other names: Naropin

Primary outcomes

  1. Pain Score at 3 Hours

    Time frame: 3 hours postoperative

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

Secondary outcomes

  1. 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

  2. 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

  3. Opioid Usage In-hospital at 24 Hours

    Time frame: 24 hours postoperatively

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

  4. Opioid Usage In-hospital at 48 Hours

    Time frame: 48 hours postoperatively

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

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 18, 2016
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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