Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized prospective outcomes study comparing two groups of patients. One group will receive liposomal bupivacaine plus bupivacaine and the other will receive bupivacaine alone in interscalene blocks when undergoing total shoulder arthroplasty. The purpose of the study is to determine if LB plus bupivacaine provides superior pain control compared to bupivacaine alone when injected in an interscalene block for patients undergoing total shoulder arthroplasty surgery.
Liposomal bupivacaine (LB) is a long acting local anesthetic. It is liposome encapsulated bupivacaine which allows for prolonged release of bupivacaine over a 72-hour period. Bupivacaine is a medium acting local anesthetic which provides between 6 and 24 hours of analgesia when used in a peripheral nerve block. Both medications are standard of care for use in interscalene blocks here at the U of MN.
LB has not been adequately studied in peripheral nerve blocks and has yet to be studied for use in interscalene blocks for Total Shoulder Arthroplasty (TSA) patients. It has been studied in Rotator Cuff Repairs (RCR) surgery and showed superior analgesia compared to bupivacaine.
The purpose of the study is to determine if LB plus bupivacaine provides superior pain control compared to bupivacaine alone when injected in an interscalene block for patients undergoing total shoulder arthroplasty surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposome bupivacaine interscalene block | Experimental | 10 mL of liposome bupivacaine and 10 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance |
|
| bupivacaine interscalene block | Active Comparator | 20 mL of 0.5% bupivacaine will be injected at the interscalene brachial plexus under ultrasound guidance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liposome bupivacaine | Drug | interscalene block with liposomal bupivacaine plus bupivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Use | total amount of opioid use from after surgery through 72 hours. Opioids normalized to morphine equivalents | From end of surgery through 72 hours after end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total Maximum Pain Scores f | 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 | time from end of surgery through 72 hours after end of surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James Flaherty, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
Not provided
Recruitment ceased after 70 patients completed the study per protocol
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Total of 75 included here due to dropouts along the way
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Liposome Bupivacaine Interscalene Block |
| 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 | Total Opioid Use | total amount of opioid use from after surgery through 72 hours. Opioids normalized to morphine equivalents | Posted | Median | Inter-Quartile Range | mg (morphine equivalent) | From end of surgery through 72 hours after end of surgery |
|
72 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall weeks after surgery | Ear and labyrinth disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Flaherty | University of Minnesota | 612-625-7675 | jflahert@umn.edu |
Not provided
| 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 | Jun 3, 2020 | Mar 21, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 26, 2020 | Mar 21, 2022 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bupivacaine | Drug | interscalene block with bupivacaine |
|
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 |
| 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 |
|
|
|
| Secondary | Total Maximum Pain Scores f | 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 | Posted | Median | Inter-Quartile Range | score on a scale | time from end of surgery through 72 hours after end of surgery |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 7 |
| 37 |
| EG001 | 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 | 0 | 33 | 0 | 33 | 0 | 33 |
| Balance Issues weeks after surgery | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Numbness/ swelling | Nervous system disorders | Non-systematic Assessment |
|
| Bruising/ swelling | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Appendicitis several weeks after surgery | Infections and infestations | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D000588 |
| Amines |