Postoperative Pain ManagementPhase 1NCT03428984
Study in Adult Subjects Undergoing Posterolateral Thoracotomy
A Phase 1 study testing EXPAREL in people with Postoperative Pain Management, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
Trial summary
Primary Objective: To characterize the pharmacokinetic (PK) profile of EXPAREL when administered as a posterior intercostal nerve block. Secondary Objective: To assess the safety and tolerability of EXPAREL in this surgical model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain Management
- What is being tested?
- EXPAREL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2018to 28 Sep 2018
- Phase
- Phase 1
- 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
- Males or females ≥18 years of age.
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
- Scheduled to undergo chest surgery using either minimally invasive (VATS or robotic-assisted surgery) or open techniques (posterolateral, lateral, or anterior thoracotomy or requiring insertion of an inter-rib spreader/retractor) for a primary thoracic non-infectious indication under general anesthesia.
- Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
Who cannot join
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration. Female subjects must be surgically sterile, at least 2 years menopausal, or using an acceptable method of birth control. If of childbearing potential, the subject must have a documented negative pregnancy test within 24 hours before surgery.
- Prior ipsilateral thoracotomy (the likely presence of adhesions will limit ability to perform a precise block guided by thoracoscopy). Note: previous VATS or robotic surgery is permissible.
- Any planned pleurodesis as part of the surgical procedure.
- Redo ipsilateral thoracotomy
- Received bupivacaine or any other local anesthetic within 7 days of screening.
- Body weight < 50 kilograms (110 pounds) or a body mass index ≥ 35 kg/m2.
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- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics or opioids.
- Previous participation in a liposome bupivacaine study.
- History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.
- Significant medical conditions (including widely disseminated metastatic disease) or laboratory results that, in the opinion of the investigator, indicate an increased vulnerability to study drugs and procedures.
- History of coronary or vascular stent placed within the past 3 months (may be extended to 1 year if medically indicated per physician discretion).
- Have been treated for a deep vein thrombosis, pulmonary embolism, myocardial infarction, or ischemic stroke within the past 6 months (may be extended to 1 year if medically indicated per physician discretion).
- Severely impaired renal or hepatic function (eg, serum creatinine level > 2 mg/dL [176.8 μmol/L], blood urea nitrogen level >50 mg/dL [17.9 mmol/L], serum aspartate aminotransferase [AST] level >3 times the upper limit of normal [ULN], or serum alanine aminotransferase [ALT] level > 3 times ULN).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study to Evaluate the Safety and Pharmacokinetics of EXPAREL When Administered for Postsurgical Analgesia in Subjects Undergoing Posterolateral Thoracotomy
Primary Objective: To characterize the pharmacokinetic (PK) profile of EXPAREL when administered as a posterior intercostal nerve block.
Secondary Objective: To assess the safety and tolerability of EXPAREL in this surgical model.
Read the detailed description
This is a Phase 1, single-center, open-label study designed to evaluate the safety and PK profile of EXPAREL when administered as a posterior intercostal nerve block. Twenty-four adult subjects undergoing thoracotomy are planned for enrollment.
Subjects will be screened within 30 days prior to study drug administration. During the screening visit, which must take place at least 1 day prior to surgery, subjects will be assessed for past or present neurologic, cardiac, and general medical conditions that, in the opinion of the investigator, would preclude them from study participation.
Subjects will undergo their pre-planned thoracotomy procedure per the institution's standard of care. Prior to wound closure, subjects will be given either 40 mL of study drug (20 mL EXPAREL expanded with 20 mL normal saline) or 30 mL of study drug (20 mL EXPAREL expanded with 10 mL normal saline). Subjects will remain in the hospital for a minimum of 48 hours for pharmacokinetic testing and evaluation of safety.
On Day 14, the subject will complete the study via phone call in order to collect safety data.
- Conditions
- Postoperative Pain Management
- Being tested
- EXPAREL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPARELDrug
EXAPREL 266 mg in 20 mL
| Study group | Role | What they receive |
|---|---|---|
| EXPAREL 20 + 20 | Experimental | 20 mL EXPAREL with 20 mL normal saline Receives: Drug: EXPAREL |
| EXPAREL 20 + 10 | Experimental | 20 mL EXPAREL with 10 mL normal saline Receives: Drug: EXPAREL |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of EXPAREL concentration
Area under the concentration curve for EXPAREL
Measured: 0-72 hours
Secondary outcomes (1)
Incidence of treatment-emergent adverse events
Incidence to treatment-emergent adverse events through 14 days
Measured: 0-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start3 May 2018
- Primary completion28 Sep 2018
- Study completion28 Sep 2018
Why it stopped: Slow study enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ManagementStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Rice, MD, Principal investigator, MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428984
- Sponsor's protocol ID
- 402-C-118
- Status last verified
- Feb 2019
- First submitted
- 5 Feb 2018
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Safety and Pharmacokinetics of EXPAREL When Administered for Postsurgical Analgesia in Subjects Undergoing Posterolateral Thoracotomy
- ClinicalTrials.gov ID
- NCT03428984
- Acronym / sponsor ID
- 402-C-118
- Conditions
- Postoperative Pain Management
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow study enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 3 May 2018 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 12 Feb 2018 (actual)
- 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.
Primary Objective: To characterize the pharmacokinetic (PK) profile of EXPAREL when administered as a posterior intercostal nerve block.
Secondary Objective: To assess the safety and tolerability of EXPAREL in this surgical model.
Detailed description
This is a Phase 1, single-center, open-label study designed to evaluate the safety and PK profile of EXPAREL when administered as a posterior intercostal nerve block. Twenty-four adult subjects undergoing thoracotomy are planned for enrollment.
Subjects will be screened within 30 days prior to study drug administration. During the screening visit, which must take place at least 1 day prior to surgery, subjects will be assessed for past or present neurologic, cardiac, and general medical conditions that, in the opinion of the investigator, would preclude them from study participation.
Subjects will undergo their pre-planned thoracotomy procedure per the institution's standard of care. Prior to wound closure, subjects will be given either 40 mL of study drug (20 mL EXPAREL expanded with 20 mL normal saline) or 30 mL of study drug (20 mL EXPAREL expanded with 10 mL normal saline). Subjects will remain in the hospital for a minimum of 48 hours for pharmacokinetic testing and evaluation of safety.
On Day 14, the subject will complete the study via phone call in order to collect safety data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPAREL 20 + 20 | Experimental | Drug: EXPAREL20 mL EXPAREL with 20 mL normal saline |
| EXPAREL 20 + 10 | Experimental | Drug: EXPAREL20 mL EXPAREL with 10 mL normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females ≥18 years of age.
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
- Scheduled to undergo chest surgery using either minimally invasive (VATS or robotic-assisted surgery) or open techniques (posterolateral, lateral, or anterior thoracotomy or requiring insertion of an inter-rib spreader/retractor) for a primary thoracic non-infectious indication under general anesthesia.
- Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
Key exclusion criteria (14 listed)
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration. Female subjects must be surgically sterile, at least 2 years menopausal, or using an acceptable method of birth control. If of childbearing potential, the subject must have a documented negative pregnancy test within 24 hours before surgery.
- Prior ipsilateral thoracotomy (the likely presence of adhesions will limit ability to perform a precise block guided by thoracoscopy). Note: previous VATS or robotic surgery is permissible.
- Any planned pleurodesis as part of the surgical procedure.
- Redo ipsilateral thoracotomy
- Received bupivacaine or any other local anesthetic within 7 days of screening.
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 |
|---|---|---|
| EXPARELEXAPREL 266 mg in 20 mL | Drug | EXPAREL 20 + 10, EXPAREL 20 + 20 |
Primary outcome
AUC of EXPAREL concentration
Time frame: 0-72 hours
Area under the concentration curve for EXPAREL
1 secondary outcome
Incidence of treatment-emergent adverse events
Time frame: 0-14 days
Results and safety
The study was stopped early (reason given: Slow study enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
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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.
David Rice, MD principal investigator
MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EXPAREL in people with Postoperative Pain Management, 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 4 inclusion and 14 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 6 Feb 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: Slow study enrollment). Results are not available in the source record.
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?
AUC of EXPAREL concentration (time frame: 0-72 hours). 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 6 Feb 2019.