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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
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:
The patient will be blinded to the study group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score at 3 Hours | Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain | 3 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pain Score at 24-48 Hours | Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Verner, MD | William Beaumont Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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" |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score at 3 Hours | Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain | Posted | Mean | Standard Deviation | units on a scale | 3 hours postoperative |
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged transient numbness | Nervous system disorders | Non-systematic Assessment |
Limitations of this study include single surgeon and single institution data, which affects generalizability of results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Verner | Beaumont Health | 1(248)551-9722 | jverner1@aol.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 6, 2016 | Feb 15, 2018 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2016 | Feb 15, 2018 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| D009020 | Morphine |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Epinephrine | Drug | 0.15 mg Epinephrine are injected as part of the drug "cocktail" |
|
|
| 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" |
|
|
| Ropivacaine | Drug | 30 mL 0.5% Ropivicaine are injected as part of the drug "cocktail" |
|
|
| measured once during time froma 24-48 hours postoperative |
| Opioid Usage In-hospital at 24 Hours | Total amount of opioids used per patient (measured with Morphine Equivalent Units) | 24 hours postoperatively |
| Opioid Usage In-hospital at 48 Hours | Total amount of opioids used per patient (measured with Morphine Equivalent Units) | 48 hours postoperatively |
| BG001 |
| 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" |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Preoperative Pain Score | Visual Analog Pain Score; 0=no pain, 10=maximum pain | Mean | Standard Deviation | units on a scale |
|
|
|
|
| Secondary | Pain Score at 3-24 Hours | Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain | Posted | Mean | Standard Deviation | units on a scale | 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 | Posted | Mean | Standard Deviation | units on a scale | 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) | Posted | Mean | Standard Deviation | Morphine Equivalent Units (Oral) | 24 hours postoperatively |
|
|
|
|
| Secondary | Opioid Usage In-hospital at 48 Hours | Total amount of opioids used per patient (measured with Morphine Equivalent Units) | Posted | Mean | Standard Deviation | Morphine Equivalent Units (Oral) | 48 hours postoperatively |
|
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 5 |
| 49 |
| EG001 | 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" | 0 | 50 | 0 | 50 | 1 | 50 |
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| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |