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The purpose of this study is to evaluate the movement of the diaphragm after an interscalene block with liposome bupivacaine (LB) compared to interscalene block (IB) with bupivacaine. This study will evaluate if there is a possible prolonged phrenic nerve paralysis when using liposome bupivacaine in an interscalene block, using ultrasound.
This study will be run concurrently with two other studies comparing bupivacaine to Liposomal Bupivacaine in shoulder surgeries. We will use already randomized patients for our randomization process. For this study in particular we will use an ultrasound machine to scan the diaphragm of any patient who had an Interscalene Block for Total Shoulder Arthroplasy or Rotator Cuff Repair. Patients are to be scanned in an upright sitting position and scanned from a low intercostal or subcostal approach using the liver or spleen as an acoustic window. M Mode will be applied and the range of diaphragmatic movement from the resting expiratory position to deep inspiration (sigh test) will be recorded as was the range of diaphragmatic movement from resting expiratory position when quickly inspiring through the nose (sniff test). The blocks will be done regardless of the study as they are standard of care for pain control. The only intervention is ultrasound examination of the patient's diaphragm at baseline, 3 hours post block in recovery room and on post-operative day 1, and basic spirometry to record FEV1 and FVC via a portable spirometer at the same time points. If patients did stay in hospital on postoperative day 2 we would also evaluate their diaphragm function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| liposomal bupivacaine | Experimental | These patients receive an interscalene block with liposomal bupivacaine. |
|
| bupivacaine | Active Comparator | These patients receive an interscalene block with bupivacaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liposomal bupivacaine | Drug | Experimental |
| |
| bupivacaine |
| Measure | Description | Time Frame |
|---|---|---|
| Diaphragm Excursion With Sigh | Evaluation of diaphragm excursion (movement in cm) from rest to sigh in a sitting position. | change from baseline to 24 hours after block |
| Measure | Description | Time Frame |
|---|---|---|
| Diaphragm Excursion With Quick Inspiratory Breath | Evaluation of diaphragm excursion (movement in cm) from rest to a quick inspiratory breath. | change from baseline to 24 hours after block |
| Forced Expiratory Volume in 1 Second (FEV1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason habeck, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine | These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental |
| FG001 | Bupivacaine | These patients receive an interscalene block with bupivacaine. bupivacaine: Active comparator |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine | These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental |
| BG001 | Bupivacaine | These patients receive an interscalene block with bupivacaine. bupivacaine: Active comparator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Diaphragm Excursion With Sigh | Evaluation of diaphragm excursion (movement in cm) from rest to sigh in a sitting position. | Posted | Median | Inter-Quartile Range | cm | change from baseline to 24 hours after block |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liposomal Bupivacaine | These patients receive an interscalene block with liposomal bupivacaine. liposomal bupivacaine: Experimental |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Habeck | University of Minnesota | 612-625-7675 | habe0073@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2019 | Mar 4, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 17, 2019 | Mar 4, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Drug |
Active comparator |
|
Evaluation of FEV1 via spirometry.
| change from baseline to 24 hours after block |
| Forced Vital Capacity (FVC) | Evaluation of FVC via spirometry. | change from baseline to 24 hours after block |
| FEV1/FVC | Evaluation of FEV1/FVC percent via spirometry. | change from baseline to 24 hours after block |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Diaphragm Excursion With Quick Inspiratory Breath | Evaluation of diaphragm excursion (movement in cm) from rest to a quick inspiratory breath. | Posted | Median | Inter-Quartile Range | cm | change from baseline to 24 hours after block |
|
|
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) | Evaluation of FEV1 via spirometry. | Posted | Median | Inter-Quartile Range | liters | change from baseline to 24 hours after block |
|
|
|
| Secondary | Forced Vital Capacity (FVC) | Evaluation of FVC via spirometry. | Posted | Median | Inter-Quartile Range | liters | change from baseline to 24 hours after block |
|
|
|
| Secondary | FEV1/FVC | Evaluation of FEV1/FVC percent via spirometry. | Posted | Median | Inter-Quartile Range | percent | change from baseline to 24 hours after block |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Bupivacaine | These patients receive an interscalene block with bupivacaine. bupivacaine: Active comparator | 0 | 12 | 0 | 12 | 0 | 12 |
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| D000588 |
| Amines |