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
• Sponsor: William Beaumont Hospitals
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Psoas Compartment Block	Periarticular Local Anesthetic
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

Baseline Characteristics

Arm/Group Title		Psoas Compartment Block	Periarticular Local Anesthetic	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Pain Score at 3 Hours
Description	Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Time Frame	3 hours postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psoas Compartment Block	Periarticular Local Anesthetic
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)

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
Description	Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Time Frame	measured once during time frame 3 hours-24 hours postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psoas Compartment Block	Periarticular Local Anesthetic
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)

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
Description	Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Time Frame	measured once during time froma 24-48 hours postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psoas Compartment Block	Periarticular Local Anesthetic
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)

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
Description	Total amount of opioids used per patient (measured with Morphine Equivalent Units)
Time Frame	24 hours postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psoas Compartment Block	Periarticular Local Anesthetic
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)

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
Description	Total amount of opioids used per patient (measured with Morphine Equivalent Units)
Time Frame	48 hours postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psoas Compartment Block	Periarticular Local Anesthetic
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)

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]

Adverse Events

Time Frame	3 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Psoas Compartment Block		Periarticular Local Anesthetic
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%)
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%)
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 and Caveats

Limitations of this study include single surgeon and single institution data, which affects generalizability of results.

More Information

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

• Name/Title: Dr. James Verner
• Organization: Beaumont Health
• Phone: 1(248)551-9722
• EMail: jverner1@aol.com

• 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