Trial Outcomes & Findings for Liposome Bupivacaine Interscalene Total Shoulder (NCT NCT03587636)

NCT ID: NCT03587636

Last Updated: 2022-05-02

Results Overview

total amount of opioid use from after surgery through 72 hours. Opioids normalized to morphine equivalents

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 77 participants
• Primary outcome timeframe: From end of surgery through 72 hours after end of surgery
• Results posted on: 2022-05-02

Participant Flow

Recruitment ceased after 70 patients completed the study per protocol

Participant milestones

Measure	Bupivacaine Interscalene Block 20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance. Bupivacaine: interscalene block with bupivacaine	Liposome Bupivacaine Interscalene Block 10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance liposome bupivacaine: interscalene block with liposomal bupivacaine plus bupivacaine
Overall Study STARTED	39	38
Overall Study COMPLETED	37	33
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Measure	Bupivacaine Interscalene Block 20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance. Bupivacaine: interscalene block with bupivacaine	Liposome Bupivacaine Interscalene Block 10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance liposome bupivacaine: interscalene block with liposomal bupivacaine plus bupivacaine
Overall Study Lost to Follow-up	2	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Bupivacaine Interscalene Block n=38 Participants 20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance. Bupivacaine: interscalene block with bupivacaine	Liposome Bupivacaine Interscalene Block n=37 Participants 10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance liposome bupivacaine: interscalene block with liposomal bupivacaine plus bupivacaine	Total n=75 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=38 Participants	0 Participants n=37 Participants	0 Participants n=75 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=38 Participants	14 Participants n=37 Participants	29 Participants n=75 Participants
Age, Categorical >=65 years	23 Participants n=38 Participants	23 Participants n=37 Participants	46 Participants n=75 Participants
Sex: Female, Male Female	22 Participants n=38 Participants	15 Participants n=37 Participants	37 Participants n=75 Participants
Sex: Female, Male Male	16 Participants n=38 Participants	22 Participants n=37 Participants	38 Participants n=75 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: From end of surgery through 72 hours after end of surgery

total amount of opioid use from after surgery through 72 hours. Opioids normalized to morphine equivalents

Outcome measures

Measure	Bupivacaine Interscalene Block n=37 Participants 20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance. Bupivacaine: interscalene block with bupivacaine	Liposome Bupivacaine Interscalene Block n=33 Participants 10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance liposome bupivacaine: interscalene block with liposomal bupivacaine plus bupivacaine
Total Opioid Use	22.5 mg (morphine equivalent) Interval 7.5 to 96.0	30.0 mg (morphine equivalent) Interval 5.6 to 45.0

SECONDARY outcome

Timeframe: time from end of surgery through 72 hours after end of surgery

Sum total of maximal pain scores through 72 horus after surgery. Pain scores reported on a numerical rating scale from 0-10. 10 is worse and 0 is best

Outcome measures

Measure	Bupivacaine Interscalene Block n=37 Participants 20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance. Bupivacaine: interscalene block with bupivacaine	Liposome Bupivacaine Interscalene Block n=33 Participants 10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance liposome bupivacaine: interscalene block with liposomal bupivacaine plus bupivacaine
Total Maximum Pain Scores f	4.0 score on a scale Interval 2.0 to 6.0	3.0 score on a scale Interval 1.0 to 5.5

Adverse Events

Bupivacaine Interscalene Block

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Liposome Bupivacaine Interscalene Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bupivacaine Interscalene Block n=37 participants at risk 20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance. Bupivacaine: interscalene block with bupivacaine	Liposome Bupivacaine Interscalene Block n=33 participants at risk 10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance liposome bupivacaine: interscalene block with liposomal bupivacaine plus bupivacaine
Ear and labyrinth disorders Fall weeks after surgery	5.4% 2/37 • Number of events 2 • 72 hours	0.00% 0/33 • 72 hours
Ear and labyrinth disorders Balance Issues weeks after surgery	2.7% 1/37 • Number of events 1 • 72 hours	0.00% 0/33 • 72 hours
Nervous system disorders Numbness/ swelling	2.7% 1/37 • Number of events 1 • 72 hours	0.00% 0/33 • 72 hours
Blood and lymphatic system disorders Bruising/ swelling	5.4% 2/37 • Number of events 2 • 72 hours	0.00% 0/33 • 72 hours
Infections and infestations Appendicitis several weeks after surgery	2.7% 1/37 • Number of events 1 • 72 hours	0.00% 0/33 • 72 hours

Additional Information

James Flaherty

University of Minnesota

Phone: 612-625-7675

Email: jflahert@umn.edu

Results disclosure agreements

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