| Primary | 1 Hour Pain Assessment Numeric Rating Scale During Rest | Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R) Scale name: Numeric rating scale during rest (NRS-R) The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) | | Posted | | Median | Inter-Quartile Range | units on a scale | | 1 hour post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
|---|
| - OG0005(3 to 6)
- OG0015(3 to 6)
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Kruskal-Wallis | | .87 | | | | | | | | | | | | | | Superiority | | |
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| Primary | 8-12 Hour Pain Assessment Numeric Rating Scale During Rest | Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R) The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) | | Posted | | Median | Inter-Quartile Range | units on a scale | | 8-12 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drug Depofoam bupivacaine will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic bupivacaine HCl: The study drug bupivacaine HCl will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Primary | 24 Hour Pain Assessment Numeric Rating Scale During Rest | Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) | All randomized patients who completed the tools | Posted | | Median | Inter-Quartile Range | units on a scale | | 24 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Primary | 36 Hour Pain Assessment Numeric Rating Scale During Rest | Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) | All randomized patients who completed the tools | Posted | | Median | Inter-Quartile Range | units on a scale | | 36 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Primary | 48 Hour Pain Assessment Numeric Rating Scale During Rest | Pain will be assessed qualitatively through the use of numeric rating scale during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10. | All patients who completed tools | Posted | | Median | Inter-Quartile Range | units on a scale | | 48 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Primary | 60 Hour Pain Assessment Numeric Rating Scale During Rest | Pain will be assessed qualitatively through the use of numeric rating scale during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10. | All patients who completed tools | Posted | | Median | Inter-Quartile Range | units on a scale | | 60 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Primary | 72 Hour Pain Assessment Numeric Rating Scale During Rest | Pain will be assessed qualitatively through the use of numeric rating scale during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10. | | Posted | | Median | Inter-Quartile Range | units on a scale | | 72 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
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| Primary | 84 Hour Pain Assessment Numeric Rating Scale During Rest | Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10. | | Posted | | Median | Inter-Quartile Range | units on a scale | | 84 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Primary | 96 Hour Pain Assessment Numeric Rating Scale During Rest | Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) Range 0-10 | All randomized patients who completed the tools | Posted | | Median | Inter-Quartile Range | units on a scale | | 96 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Primary | 36 Hour Pain Assessment Numeric Rating Scale During Activity | Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A). The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10. | All randomized patients who completed the tools | Posted | | Median | Inter-Quartile Range | units on a scale | | 36 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Primary | 48 Hour Pain Assessment Numeric Rating Scale During Activity | Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A). The higher scores indicate more severe pain during activity (10 meaning the worst pain,0 meaning no pain) The range is 0 to 10. | All randomized patients who completed the tools | Posted | | Median | Inter-Quartile Range | units on a scale | | 48 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Primary | 60 Hour Pain Assessment Numeric Rating Scale During Activity | Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A). The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10. | All randomized patients who completed the tools | Posted | | Median | Inter-Quartile Range | units on a scale | | 60 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Primary | 72 Hour Pain Assessment Numeric Rating Scale During Activity | Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A). The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10. | All randomized patients who completed the tools | Posted | | Median | Inter-Quartile Range | units on a scale | | 72 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Primary | 84 Hour Pain Assessment Numeric Rating Scale During Activity | Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A). The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10. | All randomized patients who completed the tools | Posted | | Median | Inter-Quartile Range | units on a scale | | 84 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Primary | 96 Hour Pain Assessment Numeric Rating Scale During Activity | Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A). The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10. | All randomized patients who completed the tools | Posted | | Median | Inter-Quartile Range | units on a scale | | 96 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Primary | 24 Hour Pain Assessment Brief Pain Inventory | Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain | All patients who used medication | Posted | | Mean | Inter-Quartile Range | units on a scale | | 24 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Primary | 48 Hour Pain Assessment Brief Pain Inventory | Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain | All participants who used medication | Posted | | Mean | Inter-Quartile Range | units on a scale | | 48 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Primary | 72 Hour Pain Assessment Brief Pain Inventory | Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain | All participants who used medication | Posted | | Mean | Inter-Quartile Range | units on a scale | | 72 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Primary | 96 Hour Pain Assessment Brief Pain Inventory | Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain | All participants who used medication | Posted | | Mean | Inter-Quartile Range | units on a scale | | 96 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Primary | 96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction | Pain will be assessed qualitatively through the use of post-operative analgesia patient satisfaction scale (0-5) The higher scores indicate more satisfied patients.( 5 would be very satisfied-less pain, 0 would indicate unsatisfied patients-more pain) | | Posted | | Count of Participants | | Participants | | 96 hours post-operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Secondary | 24 Hour Use of Rescue Analgesic | We will record the amount in milligrams and type of rescue analgesic for each patient. | All patients reporting medication use | Posted | | Mean | Standard Deviation | milligrams | | 24 hours post operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Secondary | 48 Hour Use of Rescue Analgesic | We will record the amount in milligrams and type of rescue analgesic for each patient. | All patients reporting medication use | Posted | | Mean | Standard Deviation | milligrams | | 48 hours post operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Secondary | 72 Hour Use of Rescue Analgesic | We will record the amount in milligrams and type of rescue analgesic for each patient. | All patients reporting medication use | Posted | | Mean | Standard Deviation | milligrams | | 72 hours post operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |
| Secondary | 96 Hour Use of Rescue Analgesic | We will record the amount in milligrams and type of rescue analgesic for each patient. | All patients reporting medication use | Posted | | Mean | Standard Deviation | milligrams | | 96 hours post operatively | | | | ID | Title | Description |
|---|
| OG000 | DepoFoam Bupivacaine | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | | OG001 | Bupivacaine HCl | local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. |
| |