A Phase 4 interventional study of EXPAREL in Hernia, sponsored by Pacira Pharmaceuticals, Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-03-08.
Sponsored by Pacira Pharmaceuticals, Inc · Phase 4, Interventional, and Treatment
Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the Transversus Abdominis Plane (TAP).
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.
257 studies on the registry are indexed under Hernia; 37 are open to participants now.
This study's enrollment of 13 is below the median of 80 across 167 interventional studies indexed under Hernia.
Browse Hernia studies →Pacira Pharmaceuticals, Inc is the lead sponsor of 102 studies on the registry; 3 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 17 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
undiluted EXPAREL 266 mg
Drug: EXPAREL
single dose 266 mg of undiluted EXPAREL
Also known as: bupivacaine liposome injectable suspension
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)
Time frame: 10 days
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.
Time frame: 30 days
Recruitment occurred between 20 July 2012 and 27 November 2012 at one site in the USA.
| Milestone | EXPAREL |
|---|---|
| Started | 13 |
| Completed | 13 |
| Not completed | 0 |
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)
| mg (morphine equivalents) | EXPAREL |
|---|---|
| Overall Postsurgical Analgesic Use | 9.7 ± 17.41 |
Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL.
| AEs | EXPAREL |
|---|---|
| Postsurgical AEs and SAEs Through Day 30. | 0 |
Collected over Through Day 30. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EXPAREL | — | 0/13 (0%) | 0/13 (0%) |
| Age, Categorical(Participants) | EXPAREL |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 13 |
| >=65 years | 0 |
| Age, Continuous(years) | EXPAREL |
|---|---|
| Mean | 45.7 ± 12.72 |
| Sex: Female, Male(Participants) | EXPAREL |
|---|---|
| Female | 3 |
| Male | 10 |
| Region of Enrollment(participants) | EXPAREL |
|---|---|
| United States | 13 |
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Liposomal Bupivacaine