Postoperative Pain ManagementPhase 3PLAYNCT03682302
Multicenter Study for Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL
A Phase 3 study testing Exparel and 0.5% Bupivacaine HCl in people with Postoperative Pain Management, run by Pacira Pharmaceuticals, Inc at 17 sites in United States.
Trial summary
Primary Objective: To evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects aged 6 to less than 17 years undergoing various types of surgeries. Secondary Objective: To evaluate the safety of EXPAREL in pediatric subjects aged 6 to less than 17 years undergoing various types of surgeries. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Postoperative Pain Management
- What is being tested?
- Exparel and 0.5% Bupivacaine HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 17 sitesUnited States
- Study dates
- 2 Apr 2019to 24 Sep 2019
- Phase
- Phase 3
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects whose parent(s) or guardian(s) has/have signed and dated the ICF for the subject to participate in the study, and subjects who have provided written assent to participate in the study (if capable).
- American Society of Anesthesiologists (ASA) Class 1-3.
- Male or female subjects 6 to less than 17 years of age on the day of surgery.
- Body mass index (BMI) at screening within the 5th to 95th percentile for age and sex (see Appendix 5).
- A negative pregnancy test for female subjects of childbearing potential must be available prior to the start of surgery. The pregnancy test must be conducted in the preoperative holding area according to the study site's standard of care.
- Subjects and their parent(s)/guardian(s) must be able to speak, read, and understand the language of the ICF and any instruments used for collecting subject-reported outcomes to enable accurate and appropriate responses to study assessments, and provide informed consent/assent.
- Subjects must be able to adhere to the study visit schedule and complete all study assessments.
Who cannot join
- Currently pregnant, breastfeeding, or planning to become pregnant during the study or within 1 month after study drug administration.
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics or to opioid medication.
- Contraindication to bupivacaine HCl or other amide-type local anesthetics or to opioid medication.
- Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug administration.
- Subjects with coagulopathies or immunodeficiency disorders.
- History of, suspected, or known addiction to or abuse of drugs or alcohol within the past 2 years.
Show all 10Show fewer
- Clinically significant medical or psychiatric disease that, in the opinion of the investigator, indicates an increased vulnerability to study drugs and/or procedures.
- Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
- In addition, the subject will be ineligible to receive study drug if he or she meets the following criterion during surgery:
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Shriners Hospitals for Children-Chicago
Chicago, Illinois, 60707
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
McGovern Medical School at UTHealth
Houston, Texas, 77030
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46204
Loma Linda University
Loma Linda, California, 92354
Nicklaus Children's Hospital
Miami, Florida, 33155
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55454
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73110
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Southwest Scoliosis Institute
Plano, Texas, 75075
Shriners Hospitals for Children, Northern California
Sacramento, California, 95817
Stanford University
Stanford, California, 94305
Nemours / Alfred I. DuPont Hospital for Children
Wilmington, Delaware, 19803
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: A Multicenter Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postsurgical Analgesia in Pediatric Subjects Aged 6 to Less Than 17 Years
Primary Objective: To evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects aged 6 to less than 17 years undergoing various types of surgeries.
Secondary Objective: To evaluate the safety of EXPAREL in pediatric subjects aged 6 to less than 17 years undergoing various types of surgeries.
Read the detailed description
This is a Phase 3, two-part, multi-center, open-label study designed to evaluate the PK and safety profile of EXPAREL in pediatric subjects aged 6 to less than 17 years when administered intraoperatively at the end of surgery via local infiltration. 90 pediatric subjects undergoing spine and/or cardiac surgeries are planned for enrollment.
Part 1 is a multicenter, randomized, open-label study in subjects aged 6 to less than 17 years undergoing spine or cardiac surgeries. There will be 2 treatment groups: Group 1 will include subjects aged 12 to less than 17 years, while Group 2 will include subjects aged 6 to less than 12 years
Part 2 is a multicenter, randomized, open-label, safety study in subjects aged 6 to less than 17 years undergoing spine or cardiac surgeries. There will be 2 treatment groups: Group 1 will include subjects aged 12 to less than 17 years, while Group 2 will include subjects aged 6 to less than 12 years.
Subjects will be screened within 30 days prior to study drug administration. During the screening visit, 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 spinal or cardiac surgeries per the institution's standard of care. On Day 1, eligible subjects will receive the study drug intraoperatively at the end of surgery via local infiltration into the surgical site. Dosing of EXPAREL will be based on body weight, with a starting dose of 4 mg/kg (maximum 266 mg).
There is no required length of stay in the hospital; subjects may be discharged based on the medical judgment of the treating physician.
A follow-up phone call will be scheduled for all subjects on Day 7. A final follow-up visit will be made on Day 30 to all subjects who would have received the study drug.
- Conditions
- Postoperative Pain Management
- Being tested
- Exparel, 0.5% Bupivacaine HCl
- Keywords
- Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
Also called Liposomal bupivacaine
EXPAREL 4mg/kg (maximum 266 mg)
0.5% Bupivacaine HClDrug
Also called Bupivacaine
Bupivacaine HCl 2mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 12 to less than 17 years, undergoing spine surgery, EXPAREL | Experimental | Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery. Receives: Drug: Exparel |
| Group 1: 12 to less than 17 years, undergoing spine surgery, bupivacine | Active comparator | Single dose of bupivacaine hydrochloride (HCl) 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery. Receives: Drug: 0.5% Bupivacaine HCl |
| Group 2: 6 to less than 12 years, undergoing spine surgery, EXPAREL | Experimental | Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery. Receives: Drug: Exparel |
| Group 2: 6 to less than 12 years, undergoing cardiac surgery, EXPAREL | Experimental | Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery. Receives: Drug: Exparel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-versus-time Curve (AUC) 0 to Infinity
Measured: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)
Maximum Plasma Concentration (Cmax)
Measured: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)
The Apparent Terminal Elimination Half-life (t1/2el)
Measured: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)
Apparent Clearance (CL/F)
Measured: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)
Apparent Volume of Distribution (Vd/F)
Measured: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)
Area Under the Plasma Concentration-versus-time Curve (AUC) 0 to Tlast
Measured: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start2 Apr 2019
- Primary completion30 Aug 2019
- Study completion24 Sep 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Igor Grachev, MD, PhD, Study director, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682302
- Sponsor's protocol ID
- 402-C-319
- Acronym
- PLAY
- Status last verified
- Dec 2020
- First submitted
- 20 Sep 2018
- Last updated
- 6 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Tirotta CF, de Armendi AJ, Horn ND, Hammer GB, Szczodry M, Matuszczak M, Wang NQ, Scranton R, Ballock RT. A multicenter study to evaluate the pharmacokinetics and safety of liposomal bupivacaine for postsurgical analgesia in pediatric patients aged 6 to less than 17 years (PLAY). J Clin Anesth. 2021 Dec;75:110503. doi: 10.1016/j.jclinane.2021.110503. Epub 2021 Sep 14.
PubMed 34534923
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postsurgical Analgesia in Pediatric Subjects Aged 6 to Less Than 17 Years
- ClinicalTrials.gov ID
- NCT03682302
- Acronym / sponsor ID
- PLAY / 402-C-319
- Conditions
- Postoperative Pain Management
- Keywords
- Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Posted 6 Jan 2021
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 evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects aged 6 to less than 17 years undergoing various types of surgeries.
Secondary Objective: To evaluate the safety of EXPAREL in pediatric subjects aged 6 to less than 17 years undergoing various types of surgeries.
Detailed description
This is a Phase 3, two-part, multi-center, open-label study designed to evaluate the PK and safety profile of EXPAREL in pediatric subjects aged 6 to less than 17 years when administered intraoperatively at the end of surgery via local infiltration. 90 pediatric subjects undergoing spine and/or cardiac surgeries are planned for enrollment.
Part 1 is a multicenter, randomized, open-label study in subjects aged 6 to less than 17 years undergoing spine or cardiac surgeries. There will be 2 treatment groups: Group 1 will include subjects aged 12 to less than 17 years, while Group 2 will include subjects aged 6 to less than 12 years
Part 2 is a multicenter, randomized, open-label, safety study in subjects aged 6 to less than 17 years undergoing spine or cardiac surgeries. There will be 2 treatment groups: Group 1 will include subjects aged 12 to less than 17 years, while Group 2 will include subjects aged 6 to less than 12 years.
Subjects will be screened within 30 days prior to study drug administration. During the screening visit, 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 spinal or cardiac surgeries per the institution's standard of care. On Day 1, eligible subjects will receive the study drug intraoperatively at the end of surgery via local infiltration into the surgical site. Dosing of EXPAREL will be based on body weight, with a starting dose of 4 mg/kg (maximum 266 mg).
There is no required length of stay in the hospital; subjects may be discharged based on the medical judgment of the treating physician.
A follow-up phone call will be scheduled for all subjects on Day 7. A final follow-up visit will be made on Day 30 to all subjects who would have received the study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: 12 to less than 17 years, undergoing spine surgery, EXPAREL | Experimental | Drug: ExparelSingle dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery. |
| Group 1: 12 to less than 17 years, undergoing spine surgery, bupivacine | Active comparator | Drug: 0.5% Bupivacaine HClSingle dose of bupivacaine hydrochloride (HCl) 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery. |
| Group 2: 6 to less than 12 years, undergoing spine surgery, EXPAREL | Experimental | Drug: ExparelSingle dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery. |
| Group 2: 6 to less than 12 years, undergoing cardiac surgery, EXPAREL | Experimental | Drug: ExparelSingle dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Subjects whose parent(s) or guardian(s) has/have signed and dated the ICF for the subject to participate in the study, and subjects who have provided written assent to participate in the study (if capable).
- American Society of Anesthesiologists (ASA) Class 1-3.
- Male or female subjects 6 to less than 17 years of age on the day of surgery.
- Body mass index (BMI) at screening within the 5th to 95th percentile for age and sex (see Appendix 5).
- A negative pregnancy test for female subjects of childbearing potential must be available prior to the start of surgery. The pregnancy test must be conducted in the preoperative holding area according to the study site's standard of care.
Key exclusion criteria (10 listed)
- Currently pregnant, breastfeeding, or planning to become pregnant during the study or within 1 month after study drug administration.
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics or to opioid medication.
- Contraindication to bupivacaine HCl or other amide-type local anesthetics or to opioid medication.
- Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug administration.
- Subjects with coagulopathies or immunodeficiency disorders.
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: Liposomal bupivacaineEXPAREL 4mg/kg (maximum 266 mg) | Drug | Group 1: 12 to less than 17 years, undergoing spine surgery, EXPAREL, Group 2: 6 to less than 12 years, undergoing cardiac surgery, EXPAREL, Group 2: 6 to less than 12 years, undergoing spine surgery, EXPAREL |
| 0.5% Bupivacaine HClAlso: BupivacaineBupivacaine HCl 2mg/kg | Drug | Group 1: 12 to less than 17 years, undergoing spine surgery, bupivacine |
Primary outcome
Area Under the Plasma Concentration-versus-time Curve (AUC) 0 to Infinity
Time frame: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)
Maximum Plasma Concentration (Cmax)
Time frame: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)
The Apparent Terminal Elimination Half-life (t1/2el)
Time frame: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)
Apparent Clearance (CL/F)
Time frame: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)
Apparent Volume of Distribution (Vd/F)
Time frame: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)
Area Under the Plasma Concentration-versus-time Curve (AUC) 0 to Tlast
Time frame: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34534923Tirotta CF, de Armendi AJ, Horn ND, Hammer GB, Szczodry M, Matuszczak M, Wang NQ, Scranton R, Ballock RT. A multicenter study to evaluate the pharmacokinetics and safety of liposomal bupivacaine for postsurgical analgesia in pediatric patients aged 6 to less than 17 years (PLAY). J Clin Anesth. 2021 Dec;75:110503. doi: 10.1016/j.jclinane.2021.110503. Epub 2021 Sep 14.
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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.
Igor Grachev, MD, PhD study director
Pacira Pharmaceuticals, Inc
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exparel and 0.5% Bupivacaine HCl in people with Postoperative Pain Management, run by Pacira Pharmaceuticals, Inc at 17 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 7 inclusion and 10 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 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 6 Jan 2021). 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?
Area Under the Plasma Concentration-versus-time Curve (AUC) 0 to Infinity (time frame: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03682302, which also lists 1 linked publication.
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 Jan 2021.