Trial Outcomes & Findings for Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty (NCT NCT02658149)
NCT ID: NCT02658149
Last Updated: 2018-05-09
Results Overview
Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
3 hours postoperative
Results posted on
2018-05-09
Participant Flow
Participant milestones
| Measure |
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
|
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"
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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
|
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"
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty
Baseline characteristics by cohort
| Measure |
Psoas Compartment Block
n=49 Participants
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
|
Periarticular Local Anesthetic
n=50 Participants
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"
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 8 • n=5 Participants
|
68 years
STANDARD_DEVIATION 8 • n=7 Participants
|
67 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Preoperative Pain Score
|
3.4 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 hours postoperativeVisual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Outcome measures
| Measure |
Psoas Compartment Block
n=49 Participants
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
|
Periarticular Local Anesthetic
n=50 Participants
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"
|
|---|---|---|
|
Pain Score at 3 Hours
|
4.0 units on a scale
Standard Deviation 2.2
|
2.9 units on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: measured once during time frame 3 hours-24 hours postoperativeVisual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Outcome measures
| Measure |
Psoas Compartment Block
n=49 Participants
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
|
Periarticular Local Anesthetic
n=50 Participants
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"
|
|---|---|---|
|
Pain Score at 3-24 Hours
|
1.9 units on a scale
Standard Deviation 1.7
|
1.3 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: measured once during time froma 24-48 hours postoperativeVisual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Outcome measures
| Measure |
Psoas Compartment Block
n=49 Participants
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
|
Periarticular Local Anesthetic
n=50 Participants
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"
|
|---|---|---|
|
Pain Score at 24-48 Hours
|
1.9 units on a scale
Standard Deviation 1.7
|
1.7 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 24 hours postoperativelyTotal amount of opioids used per patient (measured with Morphine Equivalent Units)
Outcome measures
| Measure |
Psoas Compartment Block
n=49 Participants
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
|
Periarticular Local Anesthetic
n=50 Participants
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"
|
|---|---|---|
|
Opioid Usage In-hospital at 24 Hours
|
19.5 Morphine Equivalent Units (Oral)
Standard Deviation 12.8
|
16.7 Morphine Equivalent Units (Oral)
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: 48 hours postoperativelyTotal amount of opioids used per patient (measured with Morphine Equivalent Units)
Outcome measures
| Measure |
Psoas Compartment Block
n=49 Participants
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
|
Periarticular Local Anesthetic
n=50 Participants
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"
|
|---|---|---|
|
Opioid Usage In-hospital at 48 Hours
|
22.3 Morphine Equivalent Units (Oral)
Standard Deviation 16.8
|
20.8 Morphine Equivalent Units (Oral)
Standard Deviation 16.4
|
Adverse Events
Psoas Compartment Block
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Periarticular Local Anesthetic
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Psoas Compartment Block
n=49 participants at risk
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
|
Periarticular Local Anesthetic
n=50 participants at risk
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"
|
|---|---|---|
|
Nervous system disorders
Prolonged transient numbness
|
10.2%
5/49 • Number of events 5 • 3 weeks
|
2.0%
1/50 • Number of events 1 • 3 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place