Liposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA)

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03913091
• Collaborator: (none)
• Enrollment: 184
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.7
• Patients Per Site Per Month: 8.1

Study Details

Study Description

Brief Summary

This is a phase IV , randomized, single-blind, single-center study comparing patient related outcomes such as postoperative pain and opioid usage for patients who receive ISB 's containing liposomal bupivacaine (Exparel®) plus 0.5% bupivacaine HCL versus 0.5% bupivacaine HCL undergoing total shoulder arthroplasty. The objective of this study is to compare opioid utilization and pain management of patients who receive Exparel in an ISB vs standard 0.5% bupivacaine HCL during the initial 72 --- hour post --- operative period. Additionally, to understand the duration of block after addition of Exparel® to bupivacaine in an Interscalene block after TSA.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Pain	Drug: Liposomal Bupivacaine; Drug: 0.5% Bupivacaine HCL	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 184 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Liposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA)
• Actual Study Start Date: Mar 1, 2019
• Actual Primary Completion Date: Jan 19, 2021
• Actual Study Completion Date: Jan 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 20 mL 0.5% Bupivacaine HCL	Drug: 0.5% Bupivacaine HCL; 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
Experimental: Interscalene nerve block with Liposomal + Bupivacaine 0.5% Administered in an Interscalene block for TSA	Drug: Liposomal Bupivacaine; Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL; Other Names: Exparel

Outcome Measures

Primary Outcome Measures

1. Opioid Utilization [24-72 hour, Post-Operative Period]

   Measure in morphine milligram equivalents [MME]

Secondary Outcome Measures

1. Opioid Utilization [Day 4-7, Post-Operative Period]

   Measure in morphine milligram equivalents [MME]

2. Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale [Day 1-7, Post-Operative Period]

   PROMIS Pain Intensity surveys are made up of three pain intensity questions, on a scale of 1-5. = No pain = Mild = Moderate = Severe = Very Severe

3. T-Scores, PROMIS Pain Intensity Scale [Day 1-7, Post-Operative Period]

   PROMIS Pain Intensity surveys are made up of three pain questions, which generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients undergoing total shoulder arthroplasty;

• Patients who consent to be randomized.

Exclusion Criteria:

• Patients younger than 18 and older than 75;

• Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;

• Patients who are allergic to oxycodone;

• Patients who are unable to speak English;

• Patients with diagnosed or self---reported cognitive dysfunction;

• Patients with a history of neurologic disorder that can interfere with pain sensation;

• Patients with a history of drug or recorded alcohol abuse;

• Patients who are unable to understand or follow instructions;

• Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;

• Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;

• Patients with BMI over 40;

• Any patient that the investigators feel cannot comply with all study related procedures;

• NYU Langone Health students, residents, faculty or staff members

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Uchenna Umeh, MD, New York Langone Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 17, 2019

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03913091
• Other Study ID Numbers: 18-01183
• First Posted: Apr 12, 2019
• Last Update Posted: Feb 1, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by NYU Langone Health: Total Shoulder Arthroplasty (TSA); Interscalene Nerve Block (ISB)
• Additional relevant MeSH terms: Shoulder Pain; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	20 mL 0.5% Bupivacaine HCL	Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%
Arm/Group Description	0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)	Administered in an Interscalene block for TSA Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
Period Title: Overall Study
STARTED	92	92
COMPLETED	72	78
NOT COMPLETED	20	14

Baseline Characteristics

Arm/Group Title	20 mL 0.5% Bupivacaine HCL	Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%	Total
Arm/Group Description	0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)	Administered in an Interscalene block for TSA Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL	Total of all reporting groups
Overall Participants	72	78	150
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.39 (8.77)	68.87 (8.83)	67.63 (8.8)
Sex: Female, Male (Count of Participants)
Female	30 41.7%	39 50%	69 46%
Male	42 58.3%	39 50%	81 54%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 9.7%	9 11.5%	16 10.7%
Not Hispanic or Latino	65 90.3%	69 88.5%	134 89.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	7 9.7%	9 11.5%	16 10.7%
White	60 83.3%	61 78.2%	121 80.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	5 6.9%	8 10.3%	13 8.7%
Region of Enrollment (participants) [Number]
United States	72 100%	78 100%	150 100%

Outcome Measures

1. Primary Outcome

Title	Opioid Utilization
Description	Measure in morphine milligram equivalents [MME]
Time Frame	24-72 hour, Post-Operative Period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	20 mL 0.5% Bupivacaine HCL	Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%
Arm/Group Description	0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)	Administered in an Interscalene block for TSA Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
Measure Participants	72	78
Mean (Standard Deviation) [Morphine Milligram Equivalents (MME)]	54.79 (15.26)	30.38 (11.62)

2. Secondary Outcome

Title	Opioid Utilization
Description	Measure in morphine milligram equivalents [MME]
Time Frame	Day 4-7, Post-Operative Period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	20 mL 0.5% Bupivacaine HCL	Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%
Arm/Group Description	0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)	Administered in an Interscalene block for TSA Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
Measure Participants	72	78
Mean (Standard Deviation) [Morphine Milligram Equivalents (MME)]	36.44 (11.13)	18.73 (7.55)

3. Secondary Outcome

Title	Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale
Description	PROMIS Pain Intensity surveys are made up of three pain intensity questions, on a scale of 1-5. = No pain = Mild = Moderate = Severe = Very Severe
Time Frame	Day 1-7, Post-Operative Period

Outcome Measure Data

Analysis Population Description

The sample size is slightly smaller because this data was not collected at the beginning of the study.

Arm/Group Title	20 mL 0.5% Bupivacaine HCL	Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%
Arm/Group Description	0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)	Administered in an Interscalene block for TSA Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
Measure Participants	67	72
"In the past 7 days, how intense was your pain at its worst?"	3.7 (1.16)	3.07 (1.02)
"In the past 7 days, how intense was your average pain?"	2.81 (1.2)	2.39 (1)
"What is your level of pain right now?"	2.22 (1.16)	1.83 (1.02)

4. Secondary Outcome

Title	T-Scores, PROMIS Pain Intensity Scale
Description	PROMIS Pain Intensity surveys are made up of three pain questions, which generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population.
Time Frame	Day 1-7, Post-Operative Period

Outcome Measure Data

Analysis Population Description

The sample size is slightly smaller because this data was not collected at the beginning of the study.

Arm/Group Title	20 mL 0.5% Bupivacaine HCL	Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%
Arm/Group Description	0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)	Administered in an Interscalene block for TSA Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
Measure Participants	67	72
Mean (Standard Deviation) [T-Score]	46.48 (7.6)	50.8 (7.4)

Adverse Events

Time Frame	1 month
Arm/Group Title	20 mL 0.5% Bupivacaine HCL		Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%
Arm/Group Description	0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)		Administered in an Interscalene block for TSA Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
All Cause Mortality
	20 mL 0.5% Bupivacaine HCL		Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/78 (0%)
Serious Adverse Events
	20 mL 0.5% Bupivacaine HCL		Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/78 (0%)
Other (Not Including Serious) Adverse Events
	20 mL 0.5% Bupivacaine HCL		Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/72 (2.8%)		5/78 (6.4%)
Gastrointestinal disorders
ER visit due to bowel obstruction from opioids	1/72 (1.4%)		0/78 (0%)
Musculoskeletal and connective tissue disorders
Stress Fracture During Physical Therapy	0/72 (0%)		1/78 (1.3%)
Swelling on wrist/fingers 3 weeks post-op	0/72 (0%)		1/78 (1.3%)
Shoulder dislocation, required additional meds	0/72 (0%)		1/78 (1.3%)
Respiratory, thoracic and mediastinal disorders
Elevated hemi diaphragm from prolonged phrenic nerve block	0/72 (0%)		1/78 (1.3%)
Surgical and medical procedures
Revision surgery required 1 week post-op	1/72 (1.4%)		0/78 (0%)
Intra-op fracture	0/72 (0%)		1/78 (1.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.