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This is a Phase 4, prospective, open-label, non-randomized, sequential study with two treatment groups differing only in the technique used for EXPAREL administration (instillation or infiltration).
Each subject underwent bilateral augmentation mammoplasty and received the same dose of EXPAREL. This primary objective of this study was to assess the efficacy of EXPAREL when administered via infiltration versus instillation as part of bilateral augmentation mammoplasty. The secondary objectives were to further assess other efficacy measures and the safety profile of EXPAREL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infiltration - EXPAREL | Active Comparator | Group 2 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be administered via local infiltration into each surgical site per the surgeon's normal practice at the beginning of surgery. |
|
| Instillation - EXPAREL | Experimental | Group 1 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be instilled into each breast pocket at the beginning of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Instillation - EXPAREL | Drug | Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Analgesia | The primary outcome measure is the duration of analgesia, measured by the time (hours) from the end surgery to the subject's first postsurgical opioid administration. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total Postsurgical Opioid Consumption in the Surgical Center | Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group. | 10 days |
| Pain Intensity Assessment Upon Waking in the PACU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Del Vecchio, MD | Steward Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steward St. Elizabeth's Medical Center | Brighton | Massachusetts | 02135 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Infiltration - EXPAREL | Subjects received EXPAREL 266 mg via infiltration. |
| FG001 | Instillation - EXPAREL | Subjects received EXPAREL 266 mg via instillation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
19 subjects were enrolled, 9 in the Infiltration - EXPAREL group and 10 in the Instillation - EXPAREL group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Infiltration - EXPAREL | Group 2 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be administered via local infiltration into each surgical site per the surgeon's normal practice at the beginning of surgery. Instillation - EXPAREL: Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed. |
| 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 | Duration of Analgesia | The primary outcome measure is the duration of analgesia, measured by the time (hours) from the end surgery to the subject's first postsurgical opioid administration. | Of the 8 subjects in the Infiltration - EXPAREL group (efficacy analysis set), 5 were censored, leaving 3 subjects who were administered an opioid. Of the 9 subjects in the Instillation - EXPAREL group (efficacy analysis set), 7 were censored, leaving 2 subjects who were administered an opioid. | Posted | Number | hours | 10 days |
|
From surgery through Day 10.
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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 | Infiltration - EXPAREL | Subjects received 266 mg EXPAREL via infiltration |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erol Onel, MD | Pacira Pharmaceuticals, Inc. | 858-625-2424 | erol.onel@pacira.com |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
| Infiltration - EXPAREL | Drug | IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed. |
|
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Subject-reported pain assessment upon waking in the PACU on a scale of 0 to 10 where 0 = no pain and 10 = worst possible pain.
| Upon waking in the PACO post surgery |
| Pain Intensity Assessment at the Time of Hospital Discharge | Subject-reported pain assessment at the time of hospital discharge (assessed an average of 3.11 hours after surgery for the Instillation group and 3.20 hours after surgery for the Infiltration group) on a scale from 0 to 10 where 0 = no pain and 10 = worst possible pain. | At the time of hospital discharge |
| Time to Hospital Discharge Being Written | The time (hours) to the hospital discharge being written for subjects in each group, | At the time of hospital discharge |
| Incidence of Opioid-Related Adverse Events | The incidence of adverse events that were assessed as opioid-related | Through 10 Days Post Surgery |
| Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge | Subject-reported satisfaction with postsurgical pain control in the categories of "extremely dissatisfied," "dissatisfied," "neither satisfied nor dissatisfied," "satisfied," and "extremely satisfied." | At the time of hospital discharge |
| Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10 | Subject-reported satisfaction with postsurgical pain control in the categories of "extremely dissatisfied," "dissatisfied," "neither satisfied nor dissatisfied," "satisfied," and "extremely satisfied." | Day 10 after surgery |
| BG001 | Instillation - EXPAREL | Group 1 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be instilled into each breast pocket at the beginning of surgery. Infiltration - EXPAREL: IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| ASA Classification | There were 19 subjects enrolled. 8 subjects in the Infiltration - EXPAREL group were in the safety analysis set. 10 subjects in the Instillation - EXPAREL group were in the safety analysis set. ASA Class 1 is defined as a normal healthy subject; ASA Class 2 is defined as a subject with mild systemic disease. | Number | participants |
|
Subjects received EXPAREL 266 mg via instillation.
|
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| Secondary | Total Postsurgical Opioid Consumption in the Surgical Center | Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group. | There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set. | Posted | Mean | Standard Deviation | mg | 10 days |
|
|
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| Secondary | Pain Intensity Assessment Upon Waking in the PACU | Subject-reported pain assessment upon waking in the PACU on a scale of 0 to 10 where 0 = no pain and 10 = worst possible pain. | There were 9 subjects in the Infiltration - EXPAREL efficacy analysis set and 8 subjects in the Instillation - EXPAREL efficacy analysis set. | Posted | Mean | Standard Deviation | units on a scale | Upon waking in the PACO post surgery |
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|
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| Secondary | Pain Intensity Assessment at the Time of Hospital Discharge | Subject-reported pain assessment at the time of hospital discharge (assessed an average of 3.11 hours after surgery for the Instillation group and 3.20 hours after surgery for the Infiltration group) on a scale from 0 to 10 where 0 = no pain and 10 = worst possible pain. | There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set. | Posted | Mean | Standard Deviation | units on a scale | At the time of hospital discharge |
|
|
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| Secondary | Time to Hospital Discharge Being Written | The time (hours) to the hospital discharge being written for subjects in each group, | There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set. | Posted | Mean | Standard Deviation | hours | At the time of hospital discharge |
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| Secondary | Incidence of Opioid-Related Adverse Events | The incidence of adverse events that were assessed as opioid-related | There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set. | Posted | Number | participants | Through 10 Days Post Surgery |
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|
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| Secondary | Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge | Subject-reported satisfaction with postsurgical pain control in the categories of "extremely dissatisfied," "dissatisfied," "neither satisfied nor dissatisfied," "satisfied," and "extremely satisfied." | There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set. | Posted | Number | participants | At the time of hospital discharge |
|
|
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| Secondary | Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10 | Subject-reported satisfaction with postsurgical pain control in the categories of "extremely dissatisfied," "dissatisfied," "neither satisfied nor dissatisfied," "satisfied," and "extremely satisfied." | There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set. | Posted | Number | participants | Day 10 after surgery |
|
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|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Instillation - EXPAREL | Subjects received 266 mg EXPAREL via instillation | 0 | 10 | 0 | 10 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Neither Satisfied nor Dissatisfied |
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| Satisfied |
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| Extremely Satisfied |
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| Neither Satisfied nor Dissatisfied |
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| Satisfied |
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| Extremely Satisfied |
|