Postoperative PainNCT01076686
Observational Study to Assess Long-Term Follow-Up of Breast Augmentation Subjects
An observational study of Postoperative Pain, run by Pacira Pharmaceuticals, Inc.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Mar 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients who had been exposed to study drug and had undergone breast augmentation.
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: An Observational Study to Assess the Long-Term Follow-Up of Subjects Who Had Participated in SKY0402 Breast Augmentation Studies
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Questionnaire and Physical Exam
- Keywords
- Augmentation mammoplasty, Breast augmentation, Postoperative pain, Analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamDrug
A 10-question survey and a six-item physical exam were completed.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine and low dose SKY0402 | Not described Receives: Drug: Questionnaire and Physical Exam | |
| Bupivacaine and high dose SKY0402 | Not described Receives: Drug: Questionnaire and Physical Exam | |
| Bupivacaine | Not described Receives: Drug: Questionnaire and Physical Exam | |
| High dose SKY0402 | Not described Receives: Drug: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 to 24 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076686
- Sponsor's protocol ID
- SKY0402-C-318
- Status last verified
- Dec 2011
- First submitted
- 25 Feb 2010
- Last updated
- 14 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Minkowitz HS, Onel E, Patronella CK, Smoot JD. A two-year observational study assessing the safety of DepoFoam bupivacaine after augmentation mammaplasty. Aesthet Surg J. 2012 Feb;32(2):186-93. doi: 10.1177/1090820X11434524. Epub 2012 Jan 11.
PubMed 22238339
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Assess the Long-Term Follow-Up of Subjects Who Had Participated in SKY0402 Breast Augmentation Studies
- ClinicalTrials.gov ID
- NCT01076686
- Acronym / sponsor ID
- SKY0402-C-318
- Conditions
- Postoperative Pain
- Keywords
- Augmentation mammoplasty, Breast augmentation, Postoperative pain, Analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 26 Feb 2010 (estimated)
- Results
- Posted 14 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine and low dose SKY0402 | – | Drug: Questionnaire and Physical Exam |
| Bupivacaine and high dose SKY0402 | – | Drug: Questionnaire and Physical Exam |
| Bupivacaine | – | Drug: Questionnaire and Physical Exam |
| High dose SKY0402 | – | Drug: Questionnaire and Physical Exam |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who had been exposed to study drug and had undergone breast augmentation.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and Physical ExamA 10-question survey and a six-item physical exam were completed. | Drug | Bupivacaine, Bupivacaine and high dose SKY0402, Bupivacaine and low dose SKY0402, High dose SKY0402 |
Primary outcome
Number of Subjects With Breast Implant Rupture
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22238339Minkowitz HS, Onel E, Patronella CK, Smoot JD. A two-year observational study assessing the safety of DepoFoam bupivacaine after augmentation mammaplasty. Aesthet Surg J. 2012 Feb;32(2):186-93. doi: 10.1177/1090820X11434524. Epub 2012 Jan 11.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Pacira Pharmaceuticals, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Breast Implant Rupture (time frame: 12 to 24 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01076686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2012.