PainPhase 4NCT02542956
Comparison of Local Anesthetic Infusion Pump Versus DepoFoam Bupivacaine for Pain Management
A Phase 4 study testing Exparel and Marcaine in people with Pain, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this study is to identify the best pain management for patients undergoing abdominoplasty after massive weight loss or transverse rectus abdominis myocutaneous (TRAM) flap for breast reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Exparel and Marcaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing abdominoplasty or TRAM flap breast reconstruction
Who cannot join
- A medical condition that could interfere with study participation
- Body weight less than 50 kg
- Participating in another study involving an investigational medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Controlled Comparison of Local Anesthetic Infusion Pump Versus DepoFoam Bupivacaine For Pain Management After Abdominoplasty and TRAM Flap Breast Reconstruction.
The purpose of this study is to identify the best pain management for patients undergoing abdominoplasty after massive weight loss or transverse rectus abdominis myocutaneous (TRAM) flap for breast reconstruction. The investigator is conducting this study to compare the effectiveness of a continuous infusion pain pump versus a locally injectable long-acting anesthesia (DepoFoam bupivacaine) versus standard injectable anesthesia (bupivacaine) for post surgical pain control. These drugs and devices are approved by the FDA (Food and Drug Administration) for the purpose of pain control after surgery, and have been used for this purpose before.
Read the detailed description
The purpose of this study is to identify the best pain management for patients undergoing abdominoplasty after massive weight loss or transverse rectus abdominis myocutaneous (TRAM) flap for breast reconstruction. The investigator is conducting this study to compare the effectiveness of a continuous infusion pain pump versus a locally injectable long-acting anesthesia (DepoFoam bupivacaine) versus standard injectable anesthesia (bupivacaine) for post surgical pain control. These drugs and devices are approved by the FDA (Food and Drug Administration) for the purpose of pain control after surgery, and have been used for this purpose before.
- Conditions
- Pain
- Being tested
- Exparel, Marcaine
- Keywords
- Tummy tuck (abdominoplasty), Breast Surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
receive Exparel by injection
MarcaineDrug
receive Marcaine in a pain pump
MarcaineDrug
receive Marcaine by injection
| Study group | Role | What they receive |
|---|---|---|
| Exparel | Active comparator | Injection of Exparel Receives: Drug: Exparel |
| Marcaine | Active comparator | Receive Marcaine in a pain pump or by injection Receives: Drug: Marcaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Pain
Measured: 30 minute to 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donna Tepper M.D, Henry Ford Health System
- Investigators
- Donna Tepper, M.D, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542956
- Sponsor's protocol ID
- SR91333
- Status last verified
- Jan 2022
- First submitted
- 3 Sep 2015
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled Comparison of Local Anesthetic Infusion Pump Versus DepoFoam Bupivacaine For Pain Management After Abdominoplasty and TRAM Flap Breast Reconstruction.
- ClinicalTrials.gov ID
- NCT02542956
- Acronym / sponsor ID
- SR91333
- Conditions
- Pain
- Keywords
- Tummy tuck (abdominoplasty), Breast Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify the best pain management for patients undergoing abdominoplasty after massive weight loss or transverse rectus abdominis myocutaneous (TRAM) flap for breast reconstruction. The investigator is conducting this study to compare the effectiveness of a continuous infusion pain pump versus a locally injectable long-acting anesthesia (DepoFoam bupivacaine) versus standard injectable anesthesia (bupivacaine) for post surgical pain control. These drugs and devices are approved by the FDA (Food and Drug Administration) for the purpose of pain control after surgery, and have been used for this purpose before.
Detailed description
The purpose of this study is to identify the best pain management for patients undergoing abdominoplasty after massive weight loss or transverse rectus abdominis myocutaneous (TRAM) flap for breast reconstruction. The investigator is conducting this study to compare the effectiveness of a continuous infusion pain pump versus a locally injectable long-acting anesthesia (DepoFoam bupivacaine) versus standard injectable anesthesia (bupivacaine) for post surgical pain control. These drugs and devices are approved by the FDA (Food and Drug Administration) for the purpose of pain control after surgery, and have been used for this purpose before.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exparel | Active comparator | Drug: ExparelInjection of Exparel |
| Marcaine | Active comparator | Drug: MarcaineReceive Marcaine in a pain pump or by injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing abdominoplasty or TRAM flap breast reconstruction
Key exclusion criteria (3 listed)
- A medical condition that could interfere with study participation
- Body weight less than 50 kg
- Participating in another study involving an investigational medication
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 |
|---|---|---|
| Exparelreceive Exparel by injection | Drug | Exparel |
| Marcainereceive Marcaine in a pain pump | Drug | Marcaine |
| Marcainereceive Marcaine by injection | Drug | Marcaine |
Primary outcome
Recurrence of Pain
Time frame: 30 minute to 72 hours after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
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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.
Donna Tepper, M.D principal investigator
Henry Ford Health System
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 Exparel and Marcaine in people with Pain, run by Henry Ford Health System 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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 1 Feb 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Recurrence of Pain (time frame: 30 minute to 72 hours after surgery). 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 1 Feb 2022.