MammoplastyPhase 4NCT01582490
Study of EXPAREL in Patients Undergoing Breast Augmentation
A Phase 4 study testing Instillation - EXPAREL and Infiltration - EXPAREL in people with Mammoplasty and Postoperative Pain, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Mammoplasty, Postoperative Pain
- What is being tested?
- Instillation - EXPAREL and Infiltration - EXPAREL
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Nov 2012
- Phase
- Phase 4
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, 18-75 years of age inclusive.
- American Society of Anesthesiologists (ASA) physical status 1-3.
- Undergoing bilateral augmentation mammoplasty without any concurrent surgical procedure(s).
- Physically and mentally able to participate in the study and complete all study assessments.
- Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the study components.
Who cannot join
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
- Any subject whose anatomy or surgical procedure might, in the opinion of the Investigator, preclude the potential successful local administration of EXPAREL.
- Subjects currently pregnant or who may become pregnant during the course of the study.
- Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.
- Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Steward St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135
About this study
Official title: Evaluation of the Safety and Efficacy of EXPAREL® (Bupivacaine Liposome Injectable Suspension) When Administered Via Infiltration Versus Instillation in Subjects Undergoing Bilateral Augmentation Mammoplasty
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).
Read the detailed description
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.
- Conditions
- Mammoplasty, Postoperative Pain
- Being tested
- Instillation - EXPAREL, Infiltration - EXPAREL
- Keywords
- Mammoplasty, 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.
Instillation - EXPARELDrug
Also called bupivacaine liposomal injectable suspension
Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.
Infiltration - EXPARELDrug
Also called bupivacaine liposomal injectable suspension
IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Instillation - EXPAREL |
| 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. Receives: Drug: Infiltration - EXPAREL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days
Secondary outcomes (7)
Total Postsurgical Opioid Consumption in the Surgical Center
Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group.
Measured: 10 days
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.
Measured: 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.
Measured: 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,
Measured: At the time of hospital discharge
Incidence of Opioid-Related Adverse Events
The incidence of adverse events that were assessed as opioid-related
Measured: 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."
Measured: 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."
Measured: Day 10 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2012
- Study completionNov 2012
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.
- Other trials for MammoplastyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Del Vecchio, MD, Principal investigator, Steward Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582490
- Sponsor's protocol ID
- MA402S23B901
- Status last verified
- May 2014
- First submitted
- 19 Apr 2012
- Last updated
- 2 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of EXPAREL® (Bupivacaine Liposome Injectable Suspension) When Administered Via Infiltration Versus Instillation in Subjects Undergoing Bilateral Augmentation Mammoplasty
- ClinicalTrials.gov ID
- NCT01582490
- Acronym / sponsor ID
- MA402S23B901
- Conditions
- Mammoplasty, Postoperative Pain
- Keywords
- Mammoplasty, Postoperative pain, Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Posted 2 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infiltration - EXPAREL | Active comparator | Drug: Instillation - EXPARELGroup 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 | Drug: Infiltration - EXPARELGroup 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female, 18-75 years of age inclusive.
- American Society of Anesthesiologists (ASA) physical status 1-3.
- Undergoing bilateral augmentation mammoplasty without any concurrent surgical procedure(s).
- Physically and mentally able to participate in the study and complete all study assessments.
- Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the study components.
Key exclusion criteria (5 listed)
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
- Any subject whose anatomy or surgical procedure might, in the opinion of the Investigator, preclude the potential successful local administration of EXPAREL.
- Subjects currently pregnant or who may become pregnant during the course of the study.
- Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.
- Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
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 |
|---|---|---|
| Instillation - EXPARELAlso: bupivacaine liposomal injectable suspensionIntravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed. | Drug | Infiltration - EXPAREL |
| Infiltration - EXPARELAlso: bupivacaine liposomal injectable suspensionIV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed. | Drug | Instillation - EXPAREL |
Primary outcome
Duration of Analgesia
Time frame: 10 days
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.
7 secondary outcomes
Total Postsurgical Opioid Consumption in the Surgical Center
Time frame: 10 days
Pain Intensity Assessment Upon Waking in the PACU
Time frame: Upon waking in the PACO post surgery
Pain Intensity Assessment at the Time of Hospital Discharge
Time frame: At the time of hospital discharge
Time to Hospital Discharge Being Written
Time frame: At the time of hospital discharge
Incidence of Opioid-Related Adverse Events
Time frame: Through 10 Days Post Surgery
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge
Time frame: At the time of hospital discharge
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10
Time frame: Day 10 after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Daniel Del Vecchio, MD principal investigator
Steward Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Instillation - EXPAREL and Infiltration - EXPAREL in people with Mammoplasty and Postoperative Pain, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
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 5 inclusion and 5 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 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2014). 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?
Duration of Analgesia (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2014.