Arthroplasty, Osteoarthritis
Conditions
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.
Interventions
DRUGRopivacaine with NaCl
50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment
DRUGEpinephrine
0.15 mg Epinephrine are injected as part of the drug cocktail
DRUGMorphine
4 mg Morphine are injected as part of the drug cocktail
DRUGKetorolac Tromethamine
30 mg morphine are injected as part of the drug cocktail
DRUGRopivacaine
30 mL 0.5% Ropivicaine are injected as part of the drug cocktail
Sponsors
Corewell Health East
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score at 3 Hours | 3 hours postoperative | Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score at 3-24 Hours | measured once during time frame 3 hours-24 hours postoperative | Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain |
| Pain Score at 24-48 Hours | measured once during time froma 24-48 hours postoperative | Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain |
| Opioid Usage In-hospital at 24 Hours | 24 hours postoperatively | Total amount of opioids used per patient (measured with Morphine Equivalent Units) |
| Opioid Usage In-hospital at 48 Hours | 48 hours postoperatively | Total amount of opioids used per patient (measured with Morphine Equivalent Units) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
Ropivacaine with NaCl: 50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment | 49 |
| 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.
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 | 50 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Psoas Compartment Block | Periarticular Local Anesthetic | Total |
|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 8 | 68 years STANDARD_DEVIATION 8 | 67 years STANDARD_DEVIATION 8 |
| Preoperative Pain Score | 3.4 units on a scale STANDARD_DEVIATION 2.5 | 2.5 units on a scale STANDARD_DEVIATION 2.6 | 2.9 units on a scale STANDARD_DEVIATION 2.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 47 Participants | 46 Participants | 93 Participants |
| Region of Enrollment United States | 49 Participants | 50 Participants | 99 Participants |
| Sex: Female, Male Female | 26 Participants | 22 Participants | 48 Participants |
| Sex: Female, Male Male | 23 Participants | 28 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 50 |
| other Total, other adverse events | 5 / 49 | 1 / 50 |
| serious Total, serious adverse events | 0 / 49 | 0 / 50 |
Outcome results
Primary
Pain Score at 3 Hours
Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Time frame: 3 hours postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psoas Compartment Block | Pain Score at 3 Hours | 4.0 units on a scale | Standard Deviation 2.2 |
| Periarticular Local Anesthetic | Pain Score at 3 Hours | 2.9 units on a scale | Standard Deviation 2.2 |
p-value: 0.036Wilcoxon (Mann-Whitney)
Secondary
Opioid Usage In-hospital at 24 Hours
Total amount of opioids used per patient (measured with Morphine Equivalent Units)
Time frame: 24 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psoas Compartment Block | Opioid Usage In-hospital at 24 Hours | 19.5 Morphine Equivalent Units (Oral) | Standard Deviation 12.8 |
| Periarticular Local Anesthetic | Opioid Usage In-hospital at 24 Hours | 16.7 Morphine Equivalent Units (Oral) | Standard Deviation 13.6 |
p-value: 0.741t-test, 2 sided
Secondary
Opioid Usage In-hospital at 48 Hours
Total amount of opioids used per patient (measured with Morphine Equivalent Units)
Time frame: 48 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psoas Compartment Block | Opioid Usage In-hospital at 48 Hours | 22.3 Morphine Equivalent Units (Oral) | Standard Deviation 16.8 |
| Periarticular Local Anesthetic | Opioid Usage In-hospital at 48 Hours | 20.8 Morphine Equivalent Units (Oral) | Standard Deviation 16.4 |
p-value: 1t-test, 2 sided
Secondary
Pain Score at 24-48 Hours
Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Time frame: measured once during time froma 24-48 hours postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psoas Compartment Block | Pain Score at 24-48 Hours | 1.9 units on a scale | Standard Deviation 1.7 |
| Periarticular Local Anesthetic | Pain Score at 24-48 Hours | 1.7 units on a scale | Standard Deviation 1.7 |
p-value: 1Wilcoxon (Mann-Whitney)
Secondary
Pain Score at 3-24 Hours
Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Time frame: measured once during time frame 3 hours-24 hours postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psoas Compartment Block | Pain Score at 3-24 Hours | 1.9 units on a scale | Standard Deviation 1.7 |
| Periarticular Local Anesthetic | Pain Score at 3-24 Hours | 1.3 units on a scale | Standard Deviation 1.4 |
p-value: 0.204Wilcoxon (Mann-Whitney)