NCT03682302

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_3

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

April 2, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2019

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 6, 2021

Completed
Last Updated

January 6, 2021

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

September 20, 2018

Results QC Date

October 30, 2020

Last Update Submit

December 10, 2020

Conditions

Postoperative Pain Management

Keywords

Pediatric

Outcome Measures

Primary Outcomes (6)

  • Area Under the Plasma Concentration-versus-time Curve (AUC) 0 to Infinity

    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)

    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)

    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)

    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)

    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

    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)

Study Arms (4)

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.

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.

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.

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.

Drug: Exparel

Interventions

ExparelDRUG

EXPAREL 4mg/kg (maximum 266 mg)

Also known as: Liposomal bupivacaine
Group 1: 12 to less than 17 years, undergoing spine surgery, EXPARELGroup 2: 6 to less than 12 years, undergoing cardiac surgery, EXPARELGroup 2: 6 to less than 12 years, undergoing spine surgery, EXPAREL
0.5% Bupivacaine HClDRUG

Bupivacaine HCl 2mg/kg

Also known as: Bupivacaine
Group 1: 12 to less than 17 years, undergoing spine surgery, bupivacine

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Loma Linda University

Loma Linda, California, 92354, United States

Location

Shriners Hospitals for Children, Northern California

Sacramento, California, 95817, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Nemours / Alfred I. DuPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

Shriners Hospitals for Children-Chicago

Chicago, Illinois, 60707, United States

Location

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46204, United States

Location

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55454, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73110, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

McGovern Medical School at UTHealth

Houston, Texas, 77030, United States

Location

Southwest Scoliosis Institute

Plano, Texas, 75075, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • 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.

    PMID: 34534923DERIVED

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Pacira Medical Information
Organization
Pacira Pharmaceuticals
MedInfo@pacira.com
1-855-793-9727

Study Officials

  • Igor Grachev, MD, PhD

    Pacira Pharmaceuticals, Inc

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2018

First Posted

September 24, 2018

Study Start

April 2, 2019

Primary Completion

August 30, 2019

Study Completion

September 24, 2019

Last Updated

January 6, 2021

Results First Posted

January 6, 2021

Record last verified: 2020-12

Locations

US(17)