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| Name | Class |
|---|---|
| Pacira Pharmaceuticals, Inc | INDUSTRY |
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To assess the efficacy of interscalene liposomal bupivacaine in controlling postoperative pain scores, oral morphine equivalents and sleep quality after arthroscopic rotator cuff repair surgery as compared to interscalene catheter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal bupivacaine Interscalene Block | Experimental | Interscalene block:
|
|
| Ropivacaine Interscalene Catheter | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Postoperative Pain Scores Over a 96 Hour Timeframe | Visual analog pain scores after operation [0-10, with 10 being the worst pain] | Up to 96 hrs postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Average Postoperative Oral Morphine Equivalents Over a 96 Hour Timeframe | oral morphine equivalents of all opioid-containing medications received | Up to 96 hrs |
| Average Analgesia Satisfaction Over a 96 Hour Timeframe |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Hospital-Highlands | Birmingham | Alabama | 35205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine Block | 10 mL (133 mg) of liposomal bupivacaine mixed with 7 mL (35 mg) bolus of 0.5% bupivacaine Exparel: A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain |
| FG001 | Ropivacaine Interscalene Catheter |
Ropivacaine: A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One patient that was randomized to ropivacaine interscalene catheter arm withdrew from the study prior to intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine Block | 10 mL (133 mg) of liposomal bupivacaine mixed with 7 mL (35 mg) bolus of 0.5% bupivacaine Exparel: A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain |
| BG001 | Ropivacaine Interscalene Catheter |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Average Postoperative Pain Scores Over a 96 Hour Timeframe | Visual analog pain scores after operation [0-10, with 10 being the worst pain] | In the 96 hour timeframe, only 33 of the 35 patients in the Ropivacaine Interscalene Catheter group filled out their surveys. | Posted | Mean | Standard Deviation | score on a scale | Up to 96 hrs postoperative |
|
12 weeks
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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 Block | 10 mL (133 mg) of liposomal bupivacaine mixed with 7 mL (35 mg) bolus of 0.5% bupivacaine Exparel: A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amit Momaya | University of Alabama at Birmingham, Department of Orthopaedics | 205-930-8339 | amomaya@uabmc.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 | Dec 6, 2023 | Apr 8, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Ropivacaine | Drug | A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain |
|
Likert scale of analgesia satisfaction [0-5, with 5 being the most satisfied]
| Up to 96 hrs |
| Percentage of Participants With Analgesia Complications | Complications resulting from the method of analgesia utilized | Up to 96 hrs |
| Average Sleep Quality Over a 96 Hour Timeframe | Scale of sleep quality [0-10, with 10 being the most satisfied] | Up to 96 hrs postoperative |
| Average Hours of Painless Sleep | Hours of sleep uninterrupted by pain [numerical, hours] | Up to 96 hrs postoperative |
Ropivacaine: A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain |
| BG002 | Total | Total of all reporting groups |
| years |
|
| 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 |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Tobacco Use | Number | participants |
|
Ropivacaine: A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
|
|
| Secondary | Average Postoperative Oral Morphine Equivalents Over a 96 Hour Timeframe | oral morphine equivalents of all opioid-containing medications received | In the 96 hour timeframe, only 33 of the 35 patients in the Ropivacaine Interscalene Catheter group filled out their surveys. | Posted | Mean | Standard Deviation | morphine milligram equivalents | Up to 96 hrs |
|
|
|
| Secondary | Average Analgesia Satisfaction Over a 96 Hour Timeframe | Likert scale of analgesia satisfaction [0-5, with 5 being the most satisfied] | In the 96 hour timeframe, only 33 of the 35 patients in the Ropivacaine Interscalene Catheter group filled out their surveys. | Posted | Mean | Standard Deviation | score on a scale | Up to 96 hrs |
|
|
|
| Secondary | Percentage of Participants With Analgesia Complications | Complications resulting from the method of analgesia utilized | In the 96 hour timeframe, only 33 of the 35 patients in the Ropivacaine Interscalene Catheter group filled out their surveys. | Posted | Number | percentage of participants | Up to 96 hrs |
|
|
|
| Secondary | Average Sleep Quality Over a 96 Hour Timeframe | Scale of sleep quality [0-10, with 10 being the most satisfied] | In the 96 hour timeframe, only 33 of the 35 patients in the Ropivacaine Interscalene Catheter group filled out their surveys. | Posted | Mean | Standard Deviation | score on a scale | Up to 96 hrs postoperative |
|
|
|
| Secondary | Average Hours of Painless Sleep | Hours of sleep uninterrupted by pain [numerical, hours] | In the 96 hour timeframe, only 33 of the 35 patients in the Ropivacaine Interscalene Catheter group filled out their surveys. | Posted | Mean | Standard Deviation | hours of uninterrupted sleep (longest) | Up to 96 hrs postoperative |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 8 |
| 28 |
| EG001 | Ropivacaine Interscalene Catheter |
Ropivacaine: A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain | 0 | 33 | 0 | 33 | 12 | 33 |
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| D000588 |
| Amines |