PainPhase 4NCT02353754
Evaluation of the Safety and Efficacy of EXPAREL When Administered Into the TAP in Subjects Undergoing Cesarean Section
A Phase 4 study testing Intrathecal morphine injection and EXPAREL in people with Pain, run by Pacira Pharmaceuticals, Inc at 5 sites in United States.
Trial summary
This is a Phase 4, multicenter, open-label study evaluating EXPAREL infiltration into the transversus abdominis plane (TAP) after bupivacaine hydrochloride (HCl) spinal anesthesia in subjects undergoing elective Cesarean section (C-section). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- Intrathecal morphine injection and EXPAREL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2015to Jul 2015
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females ≥18 years of age at screening.
- Scheduled to undergo elective C-section (single or multiple births).
- American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
- Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
Who cannot join
- History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids.
- Contraindication to bupivacaine, morphine, ketorolac, ibuprofen, or acetaminophen.
- Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
- Use of any of the following medications within the times specified before surgery: long-acting opioid medication, non-steroidal anti-inflammatory drugs (NSAIDs), or aspirin (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication or acetaminophen within 24 hours.
- Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, she must be on a stable dose for at least 1 month prior to study drug administration.
- Clinically significant medical or psychiatric disease that, in the opinion of the Investigator, would constitute a contraindication to participation in the study or cause inability to comply with the study requirements.
Show all 12Show fewer
- History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medication(s), or alcohol within the past 2 years.
- Received an investigational drug within 30 days prior to study drug administration, and/or has planned administration of another investigational product or procedure while participating in this study.
- Previous participating in an EXPAREL study.
- The subject will be withdrawn from the study if she meets the following criteria:
- Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
- Her baby's 5-minute Apgar score is ≤7.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Ohio State University, Wexner Medical Center
Columbus, Ohio, 43210
University Of Minnesota
Minneapolis, Minnesota, 55455
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
Tradition Medical Center
Port Saint Lucie, Florida, 34987
Montefiore
The Bronx, New York, 10467
About this study
Official title: A Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the Transversus Abdominis Plane (TAP) After Bupivacaine Spinal Anesthesia in Subjects Undergoing Elective Cesarean Section
This is a Phase 4, multicenter, open-label study evaluating EXPAREL infiltration into the transversus abdominis plane (TAP) after bupivacaine hydrochloride (HCl) spinal anesthesia in subjects undergoing elective Cesarean section (C-section).
Read the detailed description
There will be two groups of subjects with approximately 40 subjects per group. Prior to the C-section, all subjects will receive single-shot spinal anesthesia (1.5 mL bupivacaine HCl 0.75% with dextrose 8.25%). Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Subjects in Group 2 (EXPAREL/TAP) will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).
- Conditions
- Pain
- Being tested
- Intrathecal morphine injection, EXPAREL
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal morphine injectionDrug
Also called Duramorph
0.2 mg
EXPARELDrug
Also called Bupivacaine liposome injectable suspension
266 mg
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Receives: Drug: Intrathecal morphine injection |
| EXPAREL/TAP | Experimental | Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen). Receives: Drug: EXPAREL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Postsurgical Narcotic Consumption in Morphine Equivalents
Outcome measure data refer to 7 participants who received rescue medication
Measured: Through 72 hours postdose
Secondary outcomes (2)
Total Postsurgical Narcotic Consumption in Morphine Equivalents
Outcome measure data refer to 6 participants who received rescue medication
Measured: Through 24 hours
Total Postsurgical Narcotic Consumption in Morphine Equivalents
Outcome measure data refer to 7 participants who received rescue medication
Measured: Through 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2015
- Study completionJul 2015
Why it stopped: Slow enrollment. None of the subjects received EXPAREL.
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 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erol Onel, MD, Study director, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353754
- Sponsor's protocol ID
- 402-C-402
- Status last verified
- Mar 2021
- First submitted
- 28 Jan 2015
- Last updated
- 26 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 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the Transversus Abdominis Plane (TAP) After Bupivacaine Spinal Anesthesia in Subjects Undergoing Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT02353754
- Acronym / sponsor ID
- 402-C-402
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment. None of the subjects received EXPAREL.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Posted 28 Jun 2016
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, multicenter, open-label study evaluating EXPAREL infiltration into the transversus abdominis plane (TAP) after bupivacaine hydrochloride (HCl) spinal anesthesia in subjects undergoing elective Cesarean section (C-section).
Detailed description
There will be two groups of subjects with approximately 40 subjects per group. Prior to the C-section, all subjects will receive single-shot spinal anesthesia (1.5 mL bupivacaine HCl 0.75% with dextrose 8.25%). Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Subjects in Group 2 (EXPAREL/TAP) will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: Intrathecal morphine injectionSubjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. |
| EXPAREL/TAP | Experimental | Drug: EXPARELSubjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Females ≥18 years of age at screening.
- Scheduled to undergo elective C-section (single or multiple births).
- American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
- Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
Key exclusion criteria (12 listed)
- History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids.
- Contraindication to bupivacaine, morphine, ketorolac, ibuprofen, or acetaminophen.
- Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
- Use of any of the following medications within the times specified before surgery: long-acting opioid medication, non-steroidal anti-inflammatory drugs (NSAIDs), or aspirin (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication or acetaminophen within 24 hours.
- Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, she must be on a stable dose for at least 1 month prior to study drug administration.
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 |
|---|---|---|
| Intrathecal morphine injectionAlso: Duramorph0.2 mg | Drug | Standard of Care |
| EXPARELAlso: Bupivacaine liposome injectable suspension266 mg | Drug | EXPAREL/TAP |
Primary outcome
Total Postsurgical Narcotic Consumption in Morphine Equivalents
Time frame: Through 72 hours postdose
Outcome measure data refer to 7 participants who received rescue medication
2 secondary outcomes
Total Postsurgical Narcotic Consumption in Morphine Equivalents
Time frame: Through 24 hours
Total Postsurgical Narcotic Consumption in Morphine Equivalents
Time frame: Through 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 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.
Erol Onel, MD study director
Pacira Pharmaceuticals, Inc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intrathecal morphine injection and EXPAREL in people with Pain, run by Pacira Pharmaceuticals, Inc at 5 sites 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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 26 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 5 sites 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 28 Jun 2016). 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?
Total Postsurgical Narcotic Consumption in Morphine Equivalents (time frame: Through 72 hours postdose). 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 26 Mar 2021.