Postoperative Pain
Conditions
Keywords
Augmentation mammoplasty, Breast augmentation, Postoperative pain, Analgesia
Brief summary
A history and physical focused on clinical sequelae of breast implant rupture was completed by patients to assess long-term clinical sequelae of SKY0402 and its relation to the silicon shell.
Detailed description
This was an observational, multicenter study conducted to investigate the long term follow-up of subjects who had been exposed to study drug (either SKY0402, bupivacaine HCl, or both) in prior SKY0402 breast augmentation studies. Specifically, the protocol was designed to elicit any changes in the response of the silicone shell of the implant after exposure to study drug.
Interventions
DRUGQuestionnaire and Physical Exam
A 10-question survey and a six-item physical exam were completed.
Sponsors
Pacira Pharmaceuticals, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participated in either Pacira SKY0402-C-210 or Pacira SIMPLE Breast Augmentation 315 and received a dose of SKY0402, bupivacaine HCl, or both * Able and willing to comply with all study visits and procedures. * Able to speak, read, and understand the language of the informed consent, and any other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to study assessments. * Able and willing to provide written informed consent
Exclusion criteria
* Did not receive study drug in either Pacira SKY0402-C-210 or SIMPLE Breast Augmentation 315. * Has a clinically significant systemic or psychiatric disease that may pose a significant safety risk or diminish a subject's ability to undergo all study procedures and assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Breast Implant Rupture | 12 to 24 months post surgery | Breast implant rupture and integrity were assessed by reviewing the results of history and physical focused on clinical sequelae of augmentation mammoplasty |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine and Low Dose SKY0402 Single dose of study drug was injected locally into the breast pockets | 17 |
| Bupivacaine and High Dose SKY0402 Single dose of study drug was injected locally into the breast pockets | 14 |
| Bupivacaine Single dose of study drug was injected locally into the breast pockets | 32 |
| High Dose SKY0402 Single dose of study drug was injected locally into the breast pockets | 31 |
| Total | 94 |
Baseline characteristics
| Characteristic | Total | Bupivacaine and Low Dose SKY0402 | Bupivacaine and High Dose SKY0402 | Bupivacaine | High Dose SKY0402 |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 94 Participants | 17 Participants | 14 Participants | 32 Participants | 31 Participants |
| Age Continuous | 32 years STANDARD_DEVIATION 7.2 | 32 years STANDARD_DEVIATION 7.2 | 29 years STANDARD_DEVIATION 6.3 | 31 years STANDARD_DEVIATION 7.1 | 33 years STANDARD_DEVIATION 7.6 |
| Region of Enrollment United States | 94 participants | 17 participants | 14 participants | 32 participants | 31 participants |
| Sex: Female, Male Female | 94 Participants | 17 Participants | 14 Participants | 32 Participants | 31 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 14 | 0 / 32 | 0 / 31 |
| serious Total, serious adverse events | 0 / 17 | 0 / 14 | 0 / 32 | 0 / 31 |
Outcome results
Primary
Number of Subjects With Breast Implant Rupture
Breast implant rupture and integrity were assessed by reviewing the results of history and physical focused on clinical sequelae of augmentation mammoplasty
Time frame: 12 to 24 months post surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bupivacaine and Low Dose SKY0402 | Number of Subjects With Breast Implant Rupture | 0 participants |
| Bupivacaine and High Dose SKY0402 | Number of Subjects With Breast Implant Rupture | 0 participants |
| Bupivacaine | Number of Subjects With Breast Implant Rupture | 0 participants |
| High Dose SKY0402 | Number of Subjects With Breast Implant Rupture | 0 participants |