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Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT02658149
Recruitment Status : Completed
First Posted : January 18, 2016
Results First Posted : April 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
James Verner, William Beaumont Hospitals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Osteoarthritis
Arthroplasty
Interventions Drug: Ropivacaine with NaCl
Drug: Epinephrine
Drug: Morphine
Drug: Ketorolac Tromethamine
Drug: Ropivacaine
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Psoas Compartment Block Periarticular Local Anesthetic
Hide Arm/Group Description

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

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"

Period Title: Overall Study
Started 50 50
Completed 49 50
Not Completed 1 0
Reason Not Completed
Physician Decision             1             0
Arm/Group Title Psoas Compartment Block Periarticular Local Anesthetic Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 49 50 99
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 50 participants 99 participants
65  (8) 68  (8) 67  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 50 participants 99 participants
Female
26
  53.1%
22
  44.0%
48
  48.5%
Male
23
  46.9%
28
  56.0%
51
  51.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 50 participants 99 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   4.1%
4
   8.0%
6
   6.1%
White
47
  95.9%
46
  92.0%
93
  93.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 49 participants 50 participants 99 participants
49
 100.0%
50
 100.0%
99
 100.0%
Preoperative Pain Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 49 participants 50 participants 99 participants
3.4  (2.5) 2.5  (2.6) 2.9  (2.6)
[1]
Measure Description: Visual Analog Pain Score; 0=no pain, 10=maximum pain
1.Primary Outcome
Title Pain Score at 3 Hours
Hide Description Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Time Frame 3 hours postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psoas Compartment Block Periarticular Local Anesthetic
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.0  (2.2) 2.9  (2.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Psoas Compartment Block, Periarticular Local Anesthetic
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Pain Score at 3-24 Hours
Hide Description Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Time Frame measured once during time frame 3 hours-24 hours postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psoas Compartment Block Periarticular Local Anesthetic
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.9  (1.7) 1.3  (1.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Psoas Compartment Block, Periarticular Local Anesthetic
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.204
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Pain Score at 24-48 Hours
Hide Description Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Time Frame measured once during time froma 24-48 hours postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psoas Compartment Block Periarticular Local Anesthetic
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.9  (1.7) 1.7  (1.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Psoas Compartment Block, Periarticular Local Anesthetic
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Opioid Usage In-hospital at 24 Hours
Hide Description Total amount of opioids used per patient (measured with Morphine Equivalent Units)
Time Frame 24 hours postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psoas Compartment Block Periarticular Local Anesthetic
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 49 50
Mean (Standard Deviation)
Unit of Measure: Morphine Equivalent Units (Oral)
19.5  (12.8) 16.7  (13.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Psoas Compartment Block, Periarticular Local Anesthetic
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.741
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Opioid Usage In-hospital at 48 Hours
Hide Description Total amount of opioids used per patient (measured with Morphine Equivalent Units)
Time Frame 48 hours postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psoas Compartment Block Periarticular Local Anesthetic
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 49 50
Mean (Standard Deviation)
Unit of Measure: Morphine Equivalent Units (Oral)
22.3  (16.8) 20.8  (16.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Psoas Compartment Block, Periarticular Local Anesthetic
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 3 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Psoas Compartment Block Periarticular Local Anesthetic
Hide Arm/Group Description

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

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"

All-Cause Mortality
Psoas Compartment Block Periarticular Local Anesthetic
Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)      0/50 (0.00%)    
Hide Serious Adverse Events
Psoas Compartment Block Periarticular Local Anesthetic
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/49 (0.00%)      0/50 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Psoas Compartment Block Periarticular Local Anesthetic
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/49 (10.20%)      1/50 (2.00%)    
Nervous system disorders     
Prolonged transient numbness *  5/49 (10.20%)  5 1/50 (2.00%)  1
*
Indicates events were collected by non-systematic assessment
Limitations of this study include single surgeon and single institution data, which affects generalizability of results.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. James Verner
Organization: Beaumont Health
Phone: 1(248)551-9722
EMail: jverner1@aol.com
Layout table for additonal information
Responsible Party: James Verner, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT02658149    
Other Study ID Numbers: 2015-422
First Submitted: January 14, 2016
First Posted: January 18, 2016
Results First Submitted: February 16, 2018
Results First Posted: April 9, 2018
Last Update Posted: May 9, 2018