Trial Outcomes & Findings for Evaluation of Diaphragm Movement After an Interscalene Block (NCT NCT03636542)

NCT ID: NCT03636542

Last Updated: 2022-11-30

Results Overview

Evaluation of diaphragm excursion (movement in cm) from rest to sigh in a sitting position.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 26 participants
• Primary outcome timeframe: change from baseline to 24 hours after block
• Results posted on: 2022-11-30

Participant Flow

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	12	14
Overall Study COMPLETED	10	12
Overall Study NOT COMPLETED	2	2

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 Lost to Follow-up	1	1
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Liposomal Bupivacaine n=10 Participants These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental	Bupivacaine n=12 Participants These patients receive an interscalene block with bupivacaine. bupivacaine: Active comparator	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=12 Participants	0 Participants n=22 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=10 Participants	2 Participants n=12 Participants	6 Participants n=22 Participants
Age, Categorical >=65 years	6 Participants n=10 Participants	10 Participants n=12 Participants	16 Participants n=22 Participants
Sex: Female, Male Female	6 Participants n=10 Participants	9 Participants n=12 Participants	15 Participants n=22 Participants
Sex: Female, Male Male	4 Participants n=10 Participants	3 Participants n=12 Participants	7 Participants n=22 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: change from baseline to 24 hours after block

Evaluation of diaphragm excursion (movement in cm) from rest to sigh in a sitting position.

Outcome measures

Measure	Liposomal Bupivacaine n=12 Participants These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental	Bupivacaine n=10 Participants These patients receive an interscalene block with bupivacaine. bupivacaine: Active comparator
Diaphragm Excursion With Sigh	4.2 cm Interval 1.6 to 5.0	2.9 cm Interval 1.7 to 3.5

SECONDARY outcome

Timeframe: change from baseline to 24 hours after block

Evaluation of diaphragm excursion (movement in cm) from rest to a quick inspiratory breath.

Outcome measures

Measure	Liposomal Bupivacaine n=9 Participants These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental	Bupivacaine n=12 Participants These patients receive an interscalene block with bupivacaine. bupivacaine: Active comparator
Diaphragm Excursion With Quick Inspiratory Breath	1.8 cm Interval 1.3 to 2.9	1.2 cm Interval 0.7 to 2.3

SECONDARY outcome

Timeframe: change from baseline to 24 hours after block

Evaluation of FEV1 via spirometry.

Outcome measures

Measure	Liposomal Bupivacaine n=10 Participants These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental	Bupivacaine n=12 Participants These patients receive an interscalene block with bupivacaine. bupivacaine: Active comparator
Forced Expiratory Volume in 1 Second (FEV1)	2.7 liters Interval 1.9 to 3.2	1.8 liters Interval 1.7 to 2.1

SECONDARY outcome

Timeframe: change from baseline to 24 hours after block

Evaluation of FVC via spirometry.

Outcome measures

Measure	Liposomal Bupivacaine n=10 Participants These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental	Bupivacaine n=12 Participants These patients receive an interscalene block with bupivacaine. bupivacaine: Active comparator
Forced Vital Capacity (FVC)	3.2 liters Interval 2.3 to 3.5	2.0 liters Interval 1.8 to 2.3

SECONDARY outcome

Timeframe: change from baseline to 24 hours after block

Evaluation of FEV1/FVC percent via spirometry.

Outcome measures

Measure	Liposomal Bupivacaine n=10 Participants These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental	Bupivacaine n=12 Participants These patients receive an interscalene block with bupivacaine. bupivacaine: Active comparator
FEV1/FVC	86 percent Interval 86.2 to 97.3	89.5 percent Interval 82.3 to 93.0

Adverse Events

Liposomal Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jason Habeck

University of Minnesota

Phone: 612-625-7675

Email: habe0073@umn.edu

Results disclosure agreements

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