Trial Outcomes & Findings for Liposomal Bupivacaine Interscalene Blocks for Rotator Cuff Repair (NCT NCT03587584)

Results Overview

Total amount of opioid medications used during surgery. Opioids normalized to total morphine equivalents.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

through end of surgery

Results posted on

2022-07-27

Participant milestones
Measure	Liposomal Bupivacaine These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental	Bupivacaine These patients receive an interscalene block with bupivacaine. Bupivacaine: Active Comparator
Overall Study STARTED	37	42
Overall Study COMPLETED	33	33
Overall Study NOT COMPLETED	4	9

Reasons for withdrawal
Measure	Liposomal Bupivacaine These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental	Bupivacaine These patients receive an interscalene block with bupivacaine. Bupivacaine: Active Comparator
Overall Study SOC deviations	4	6
Overall Study Incomplete data	0	3

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Liposomal Bupivacaine n=37 Participants These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental	Bupivacaine n=42 Participants These patients receive an interscalene block with bupivacaine. Bupivacaine: Active Comparator	Total n=79 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=37 Participants	0 Participants n=42 Participants	0 Participants n=79 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=37 Participants	36 Participants n=42 Participants	66 Participants n=79 Participants
Age, Categorical >=65 years	7 Participants n=37 Participants	6 Participants n=42 Participants	13 Participants n=79 Participants
Sex: Female, Male Female	22 Participants n=37 Participants	26 Participants n=42 Participants	48 Participants n=79 Participants
Sex: Female, Male Male	15 Participants n=37 Participants	16 Participants n=42 Participants	31 Participants n=79 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

Timeframe: through end of surgery

Total amount of opioid medications used during surgery. Opioids normalized to total morphine equivalents.

Outcome measures
Measure	Liposomal Bupivacaine n=33 Participants These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental	Bupivacaine n=33 Participants These patients receive an interscalene block with bupivacaine. Bupivacaine: Active Comparator
Total Intraoperative Opioids Used Intraoperative Fentanyl (mg)	.1 mg Interval 0.1 to 0.1	.1 mg Interval 0.05 to 0.1
Total Intraoperative Opioids Used Intraoperative MME (mg)	30 mg Interval 30.0 to 30.0	30 mg Interval 15.0 to 30.0
Total Intraoperative Opioids Used Intraoperative hydromorphone (mg)	0 mg Interval 0.0 to 0.0	0 mg Interval 0.0 to 0.0
Total Intraoperative Opioids Used Intraoperative ketamine	0 mg Interval 0.0 to 0.0	0 mg Interval 0.0 to 0.0
Total Intraoperative Opioids Used Intraoperative ketorolac (mg)	0 mg Interval 0.0 to 30.0	0 mg Interval 0.0 to 30.0

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Liposomal Bupivacaine n=33 participants at risk These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental	Bupivacaine n=33 participants at risk These patients receive an interscalene block with bupivacaine. Bupivacaine: Active Comparator
Gastrointestinal disorders Nausea	15.2% 5/33 • Number of events 5 • 72 hours	12.1% 4/33 • Number of events 4 • 72 hours
Gastrointestinal disorders Vomiting	3.0% 1/33 • Number of events 1 • 72 hours	6.1% 2/33 • Number of events 2 • 72 hours

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