HerniaPhase 4702NCT01801124
EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair
A Phase 4 study testing EXPAREL in people with Hernia, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
Trial summary
Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the Transversus Abdominis Plane (TAP). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hernia
- What is being tested?
- EXPAREL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, aged 18-75 years inclusive, and ASA physical status 1-3.
- Undergoing open repair of a unilateral abdominal hernia below the level of the umbilicus.
- Abdominal incision length of 3-12 cm.
- Subjects must be physically and mentally able to participate in the study and complete all study assessments.
- Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of the TAP infiltration.
Who cannot join
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
- Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP infiltration.
- Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.
- Any subject, who in the opinion of the Investigator, is on chronic pain medicine.
- Any female subject who is currently pregnant.
- 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.
About this study
Official title: Evaluation of the Safety and Efficacy of EXPAREL® When Infiltrated Into the Transversus Abdominis Plane (TAP) for Prolonged Postoperative Analgesia in Subjects Undergoing Unilateral Abdominal Hernia Repair
Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the Transversus Abdominis Plane (TAP).
Read the detailed description
This is a prospective, open-label, non-randomized study evaluating the effectiveness of abdominal analgesia when using 266 mg EXPAREL to infiltrate into the TAP unilaterally.
- Conditions
- Hernia
- Being tested
- EXPAREL
- Keywords
- analgesia, hernia repair
- Medical subject headings
- Hernia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPARELDrug
Also called bupivacaine liposome injectable suspension
single dose 266 mg of undiluted EXPAREL
| Study group | Role | What they receive |
|---|---|---|
| EXPAREL | Experimental | undiluted EXPAREL 266 mg Receives: Drug: EXPAREL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Postsurgical Analgesic Use
The effectiveness of abdominal analgesia from the infiltration into the TAP as measured by the subject's overall postsurgical analgesic use in morphine equivalents (mg)
Measured: 10 days
Secondary outcomes (1)
Postsurgical AEs and SAEs Through Day 30.
Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 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 HerniaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Kronenfeld, MD, Principal investigator, Maimonides
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801124
- Sponsor's protocol ID
- MA402S23B702
- Acronym
- 702
- Status last verified
- Feb 2021
- First submitted
- 26 Feb 2013
- Last updated
- 8 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of EXPAREL® When Infiltrated Into the Transversus Abdominis Plane (TAP) for Prolonged Postoperative Analgesia in Subjects Undergoing Unilateral Abdominal Hernia Repair
- ClinicalTrials.gov ID
- NCT01801124
- Acronym / sponsor ID
- 702 / MA402S23B702
- Conditions
- Hernia
- Keywords
- analgesia, hernia repair
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Feb 2013 (estimated)
- Results
- Posted 11 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the Transversus Abdominis Plane (TAP).
Detailed description
This is a prospective, open-label, non-randomized study evaluating the effectiveness of abdominal analgesia when using 266 mg EXPAREL to infiltrate into the TAP unilaterally.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXPAREL | Experimental | Drug: EXPARELundiluted EXPAREL 266 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females, aged 18-75 years inclusive, and ASA physical status 1-3.
- Undergoing open repair of a unilateral abdominal hernia below the level of the umbilicus.
- Abdominal incision length of 3-12 cm.
- Subjects must be physically and mentally able to participate in the study and complete all study assessments.
- Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of the TAP infiltration.
Key exclusion criteria (6 listed)
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
- Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP infiltration.
- Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.
- Any subject, who in the opinion of the Investigator, is on chronic pain medicine.
- Any female subject who is currently pregnant.
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 |
|---|---|---|
| EXPARELAlso: bupivacaine liposome injectable suspensionsingle dose 266 mg of undiluted EXPAREL | Drug | EXPAREL |
Primary outcome
Overall Postsurgical Analgesic Use
Time frame: 10 days
The effectiveness of abdominal analgesia from the infiltration into the TAP as measured by the subject's overall postsurgical analgesic use in morphine equivalents (mg)
1 secondary outcome
Postsurgical AEs and SAEs Through Day 30.
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- 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.
Mark Kronenfeld, MD principal investigator
Maimonides
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 in people with Hernia, 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 6 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 8 Mar 2021. 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 11 Sep 2013). 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?
Overall Postsurgical Analgesic Use (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 8 Mar 2021.