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This is a phase IV , randomized, single-blind, single-center study comparing patient related outcomes such as postoperative pain and opioid usage for patients who receive ISB 's containing liposomal bupivacaine (Exparel®) plus 0.5% bupivacaine HCL versus 0.5% bupivacaine HCL undergoing total shoulder arthroplasty. The objective of this study is to compare opioid utilization and pain management of patients who receive Exparel in an ISB vs standard 0.5% bupivacaine HCL during the initial 72 --- hour post --- operative period. Additionally, to understand the duration of block after addition of Exparel® to bupivacaine in an Interscalene block after TSA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 mL 0.5% Bupivacaine HCL | Experimental |
| |
| Interscalene nerve block with Liposomal + Bupivacaine 0.5% | Experimental | Administered in an Interscalene block for TSA |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Bupivacaine | Drug | Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL |
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| Measure | Description | Time Frame |
|---|---|---|
| Opioid Utilization | Measure in morphine milligram equivalents [MME] | 24-72 hour, Post-Operative Period |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Utilization | Measure in morphine milligram equivalents [MME] | Day 4-7, Post-Operative Period |
| Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uchenna Umeh, MD | New York Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Data will be available to achieve aims in the approved proposal.
Immediately following publication. No end date
Requests should be directed to uchenna.umeh@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Access will be given to researchers who provide a methodologically sound proposal and investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
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| ID | Title | Description |
|---|---|---|
| FG000 | 20 mL 0.5% Bupivacaine HCL | 0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) |
| FG001 | Interscalene Nerve Block With Liposomal + Bupivacaine 0.5% | Administered in an Interscalene block for TSA Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jul 17, 2019 |
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| 0.5% Bupivacaine HCL | Drug | 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) |
|
PROMIS Pain Intensity surveys are made up of three pain intensity questions, on a scale of 1-5.
| Day 1-7, Post-Operative Period |
| T-Scores, PROMIS Pain Intensity Scale | PROMIS Pain Intensity surveys are made up of three pain questions, which generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. | Day 1-7, Post-Operative Period |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 20 mL 0.5% Bupivacaine HCL | 0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) |
| BG001 | Interscalene Nerve Block With Liposomal + Bupivacaine 0.5% | Administered in an Interscalene block for TSA Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Opioid Utilization | Measure in morphine milligram equivalents [MME] | Posted | Mean | Standard Deviation | Morphine Milligram Equivalents (MME) | 24-72 hour, Post-Operative Period |
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| Secondary | Opioid Utilization | Measure in morphine milligram equivalents [MME] | Posted | Mean | Standard Deviation | Morphine Milligram Equivalents (MME) | Day 4-7, Post-Operative Period |
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| Secondary | Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale | PROMIS Pain Intensity surveys are made up of three pain intensity questions, on a scale of 1-5.
| The sample size is slightly smaller because this data was not collected at the beginning of the study. | Posted | Mean | Standard Deviation | score on a scale | Day 1-7, Post-Operative Period |
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| Secondary | T-Scores, PROMIS Pain Intensity Scale | PROMIS Pain Intensity surveys are made up of three pain questions, which generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. | The sample size is slightly smaller because this data was not collected at the beginning of the study. | Posted | Mean | Standard Deviation | T-Score | Day 1-7, Post-Operative Period |
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1 month
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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 | 20 mL 0.5% Bupivacaine HCL | 0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) | 0 | 72 | 0 | 72 | 2 | 72 |
| EG001 | Interscalene Nerve Block With Liposomal + Bupivacaine 0.5% | Administered in an Interscalene block for TSA Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL | 0 | 78 | 0 | 78 | 5 | 78 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stress Fracture During Physical Therapy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| ER visit due to bowel obstruction from opioids | Gastrointestinal disorders | Non-systematic Assessment |
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| Swelling on wrist/fingers 3 weeks post-op | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Revision surgery required 1 week post-op | Surgical and medical procedures | Non-systematic Assessment |
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| Elevated hemi diaphragm from prolonged phrenic nerve block | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Shoulder dislocation, required additional meds | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Intra-op fracture | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Uchenna O. Umeh, MD | NYU Langone Health | (212) 598-6085 | Uchenna.Umeh@nyulangone.org |
| Jan 3, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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