Trial Outcomes & Findings for Exparel for Total Shoulder Arthroplasty (NCT NCT04364867)

NCT ID: NCT04364867

Last Updated: 2024-11-26

Results Overview

Worst pain score (0 \[none\] to 10 \[worst possible\]) in the 24 hours after surgery

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 102 participants
• Primary outcome timeframe: 24 hours after surgery
• Results posted on: 2024-11-26

Participant Flow

Participant milestones

Measure	Exparel Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine Exparel: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine	Pain Pump Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out. Pain Pump: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.
Overall Study STARTED	51	51
Overall Study COMPLETED	19	35
Overall Study NOT COMPLETED	32	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exparel for Total Shoulder Arthroplasty

Baseline characteristics by cohort

Measure	Exparel n=19 Participants Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine Exparel: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine	Pain Pump n=35 Participants Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out. Pain Pump: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.	Total n=54 Participants Total of all reporting groups
Age, Continuous	66.5 Years STANDARD_DEVIATION 6.96 • n=5 Participants	67.15 Years STANDARD_DEVIATION 7.17 • n=7 Participants	66.68 Years STANDARD_DEVIATION 6.96 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	19 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Race · Caucasian	18 Participants n=5 Participants	33 Participants n=7 Participants	51 Participants n=5 Participants
Race/Ethnicity, Customized Race · African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	35 participants n=7 Participants	54 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours after surgery

Worst pain score (0 [none] to 10 [worst possible]) in the 24 hours after surgery

Outcome measures

Measure	Exparel n=19 Participants Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine Exparel: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine	Pain Pump n=35 Participants Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out. Pain Pump: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.
Pain Score in the 24 Hours After Surgery	0.76 score on a scale Standard Deviation 0.97	3.37 score on a scale Standard Deviation 2.86

SECONDARY outcome

Timeframe: 48 hours

Worst pain score (0 [none] to 10 [worst possible]) in the 48 hours after surgery

Outcome measures

Measure	Exparel n=19 Participants Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine Exparel: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine	Pain Pump n=35 Participants Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out. Pain Pump: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.
Pain Score in the 48 Hours After Surgery	2.53 score on a scale Standard Deviation 1.42	4.70 score on a scale Standard Deviation 3.23

SECONDARY outcome

Timeframe: 24 hours

Cumulative Morphine Milligram Equivalents consumed at 24 hours

Outcome measures

Measure	Exparel n=19 Participants Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine Exparel: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine	Pain Pump n=35 Participants Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out. Pain Pump: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.
Cumulative Morphine Milligram Equivalents at 24 Hours	4.58 Morphine Milligram Equivalents (MME) Standard Deviation 6.53	3.57 Morphine Milligram Equivalents (MME) Standard Deviation 3.84

SECONDARY outcome

Timeframe: 48 hours

Cumulative Morphine Milligram Equivalents consumed at 48 hours

Outcome measures

Measure	Exparel n=19 Participants Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine Exparel: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine	Pain Pump n=35 Participants Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out. Pain Pump: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.
Cumulative Morphine Milligram Equivalents at 48 Hours	4.58 Morphine Milligram Equivalents (MME) Standard Deviation 0.88	4.19 Morphine Milligram Equivalents (MME) Standard Deviation 0.72

SECONDARY outcome

Timeframe: 72hours

Cumulative Morphine Milligram Equivalents consumed at 72 hours

Outcome measures

Measure	Exparel n=19 Participants Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine Exparel: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine	Pain Pump n=35 Participants Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out. Pain Pump: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.
Cumulative Morphine Milligram Equivalents at 72 Hours	4.58 Morphine Milligram Equivalents (MME) Standard Deviation 00.88	4.31 Morphine Milligram Equivalents (MME) Standard Deviation 0.65

SECONDARY outcome

Timeframe: 72 hours

Worst pain score (0 [none] to 10 [worst possible]) in the 72 hours after surgery

Outcome measures

Measure	Exparel n=19 Participants Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine Exparel: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine	Pain Pump n=35 Participants Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out. Pain Pump: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.
Pain Score in the 72 Hours After Surgery	2.94 score on a scale Standard Deviation 2.73	3.69 score on a scale Standard Deviation 2.93

Adverse Events

Exparel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pain Pump

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Exparel n=19 participants at risk Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine Exparel: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine	Pain Pump n=35 participants at risk Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out. Pain Pump: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.
Product Issues Catheter Dislodgement	0.00% 0/19 • 90 days Dislodgment of pain pump catheter	5.7% 2/35 • Number of events 2 • 90 days Dislodgment of pain pump catheter

Other adverse events

Adverse event data not reported

Additional Information

Ryan Krupp MD

Orthopedic Institute, Norton Healthcare

Phone: 502-394-6341

Email: Ryan.Krupp@nortonhealthcare.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place