Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty
|ClinicalTrials.gov Identifier: NCT02658149|
Recruitment Status : Completed
First Posted : January 18, 2016
Results First Posted : April 9, 2018
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Arthroplasty||Drug: Ropivacaine with NaCl Drug: Epinephrine Drug: Morphine Drug: Ketorolac Tromethamine Drug: Ropivacaine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Psoas Compartment Block Versus Periarticular Local Anesthetic Infiltration for Pain Management for Total Hip Arthroplasty: A Prospective, Randomized Study|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||May 11, 2017|
|Actual Study Completion Date :||June 2, 2017|
Experimental: 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).
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
Other Name: Naropin with NaCl
Active Comparator: 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.
0.15 mg Epinephrine are injected as part of the drug "cocktail"
Other Name: adrenaline
4 mg Morphine are injected as part of the drug "cocktail"
Drug: Ketorolac Tromethamine
30 mg morphine are injected as part of the drug "cocktail"
Other Name: Toradol
30 mL 0.5% Ropivicaine are injected as part of the drug "cocktail"
Other Name: Naropin
- Pain Score at 3 Hours [ Time Frame: 3 hours postoperative ]Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
- 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
- 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
- Opioid Usage In-hospital at 24 Hours [ Time Frame: 24 hours postoperatively ]Total amount of opioids used per patient (measured with Morphine Equivalent Units)
- Opioid Usage In-hospital at 48 Hours [ Time Frame: 48 hours postoperatively ]Total amount of opioids used per patient (measured with Morphine Equivalent Units)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658149
|United States, Michigan|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||James Verner, MD||William Beaumont Health|