Clinical Trials

Study Title |

A Multicenter Study to Evaluate the Pharmacokinetics (PK) and Safety of EXPAREL for Postsurgical Analgesia in Pediatric Subjects Aged 6 to Less Than 17 Years

Primary Objective |

To evaluate the PK of EXPAREL® (bupivacaine liposome injectable suspension) in pediatric subjects aged 6 to less than 17 years undergoing various types of surgeries.

Study Summary

Study Status: Startup

NCT Number: NCT03682302

Study Nickname: PLAY

Enrollment goal

goal

90

Intervention(s)

intervention

EXPAREL, Bupivacaine HCl

Phase

phase

3

Condition

condition

Postsurgical pain management

Target Number of Sites: 28

Key Participation Criteria

Gender

gender

Both

Age

6<17years

Time Commitment

time

30 days

Procedures included

procedure

Cardiac or Spine

Inclusion Criteria:

  • Subjects whose parent(s) or guardian(s) has/have signed and dated the informed consent form (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 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
  • 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

Exclusion Criteria:

  • 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 (eg, excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course

Where to participate

Coordinates

Riley Hospital for Children at Indiana University Health

705 Riley hospital drive, suite 2820, Indianapolis, IN 46204

  • Site Coordinator

    Alicia Limbach | 317-948-0695

  • Site Coordinator

    Mary Heskett

  • Principal Investigator

    Nicole Horn, MD

Nicklaus Children's Hospital

3100 S.W. 62nd Ave, Miami, FL 33155

  • Principal Investigator

    Christopher Tirotta, MD

Children's Hospital of Wisconsin

9000 W. Wisconsin Ave, MS 792, Milwaukee, WI 53226

  • Principal Investigator

    Roger Fons, MD

University of Oklahoma Health Sciences Center Dept. of Anesthesiology

920 SL Young Blvd, Suite 1140, Oklahoma City, OK 73110

  • Principal Investigator

    Alberto De Armendi, MD

University of Minnesota Masonic Children's Hospital

2450 Riverside Ave, Minneapolis, MN 55454

  • Principal Investigator

    Kumar Belani, MD

OrthoCarolina

4601 Park Rd, Charlotte, NC 28209

  • Principal Investigator

    Michael Paloski, MD

Nemours Children's Hospital

13535 Nemours Parkway, Orlando, FL 32827

  • Site Coordinator

    Virginia (Ginny) Rizzo

  • Principal Investigator

    Lisgelia Santana-Rojas, MD

Shriners Hospitals for Children, Northern California

2425 Stockton Blvd, Sacramento, CA 95817 

  • Site Coordinator

    Lynda Painting

  • Principal Investigator

    Sundeep Tumber, MD

Children's Hospital of Philadelphia

3401 Civic Center Blvd, Philadelphia, PA 19104

  • Site Coordinator

    Theodora (Thea) Goebel

Stanford University

300 Pasteur Drive, Stanford, CA 94305

  • Site Coordinator

    Yan He | 650-724-2320

  • Principal Investigator

    Gregory Hammer, MD

Wake Forest Baptist Health

1 Medical Center Blvd., Winston-Salem, NC 27157

  • Site Coordinator

    Regina Curry

Southwest Scoliosis Institute

1600 Coit Road, Suite 104, Plano, TX 75075

  • Principal Investigator

    Ionnis Avramis, MD

Children's National

111 Michigan Ave NW, Washington, DC 20010

  • Principal Investigator

    Sophie Pestieau, MD

Children's Hospital Colorado

13123 East 16th Avenue, BOX 090, Aurora, CO 80045

  • Principal Investigator

    Richard Ing, MD

McGovern Medical School at UTHealth

6431 Fannin Street, Houston, TX 77030

Oregon Health & Science University

3181 SW Sam Jackson Park Road, Portland, OR 97239

  • Principal Investigator

    Weronika Crescini, MD

Cleveland Clinic

9500 Euclid Ave, Mail Code A41, Cleveland, OH 44195

  • Site Coordinator

    Brittany Hudson | 216-444-8230

    Principal Investigator

    Robert Tracy Ballock, MD (Spine)

  • Principal Investigator

    Surendrasingh Chhabada, MD (Cardiac)

Nemours / Alfred I. DuPont Hospital for Children

1600 Rockland Road, Wilmington, DE 19803

  • Principal Investigator

    Suken Shah, MD

Duke University Medical Center

2301 Erwin Rd, Durham, NC 27710

  • Principal Investigator

    Brad Taicher, MD

Shriner’s Hospital

2211 N Oak Park Ave, Chicago, IL 60707

  • Principal Investigator

    Michal Szczodry, MD

Closest Location to Participate

Riley Hospital for Children at Indiana University Health
705 Riley hospital drive, suite 2820, Indianapolis, IN 46204
  • Site Coordinator

    Alicia Limbach | 317-948-0695

  • Site Coordinator

    Mary Heskett

  • Principal Investigator

    Nicole Horn, MD

Recruiting

Nicklaus Children's Hospital
3100 S.W. 62nd Ave, Miami, FL 33155
  • Principal Investigator

    Christopher Tirotta, MD

Recruiting

Children's Hospital of Wisconsin
9000 W. Wisconsin Ave, MS 792, Milwaukee, WI 53226
  • Principal Investigator

    Roger Fons, MD

Not Yet Recruiting

University of Oklahoma Health Sciences Center Dept. of Anesthesiology
920 SL Young Blvd, Suite 1140, Oklahoma City, OK 73110
  • Principal Investigator

    Alberto De Armendi, MD

Recruiting

University of Minnesota Masonic Children's Hospital
2450 Riverside Ave, Minneapolis, MN 55454
  • Principal Investigator

    Kumar Belani, MD

Not Yet Recruiting

OrthoCarolina
4601 Park Rd, Charlotte, NC 28209
  • Principal Investigator

    Michael Paloski, MD

Not Yet Recruiting

Nemours Children's Hospital
13535 Nemours Parkway, Orlando, FL 32827
  • Site Coordinator

    Virginia (Ginny) Rizzo

  • Principal Investigator

    Lisgelia Santana-Rojas, MD

Not Yet Recruiting

Shriners Hospitals for Children, Northern California
2425 Stockton Blvd, Sacramento, CA 95817 
  • Site Coordinator

    Lynda Painting

  • Principal Investigator

    Sundeep Tumber, MD

Recruiting

Children's Hospital of Philadelphia
3401 Civic Center Blvd, Philadelphia, PA 19104
  • Site Coordinator

    Theodora (Thea) Goebel

Recruiting

Stanford University
300 Pasteur Drive, Stanford, CA 94305
  • Site Coordinator

    Yan He | 650-724-2320

  • Principal Investigator

    Gregory Hammer, MD

Recruiting

Wake Forest Baptist Health
1 Medical Center Blvd., Winston-Salem, NC 27157
  • Site Coordinator

    Regina Curry

Recruiting

Southwest Scoliosis Institute
1600 Coit Road, Suite 104, Plano, TX 75075
  • Principal Investigator

    Ionnis Avramis, MD

Not Yet Recruiting

Children's National
111 Michigan Ave NW, Washington, DC 20010
  • Principal Investigator

    Sophie Pestieau, MD

Not Yet Recruiting

Children's Hospital Colorado
13123 East 16th Avenue, BOX 090, Aurora, CO 80045
  • Principal Investigator

    Richard Ing, MD

Not Yet Recruiting

McGovern Medical School at UTHealth
6431 Fannin Street, Houston, TX 77030

Recruiting

Oregon Health & Science University
3181 SW Sam Jackson Park Road, Portland, OR 97239
  • Principal Investigator

    Weronika Crescini, MD

Not Yet Recruiting

Cleveland Clinic
9500 Euclid Ave, Mail Code A41, Cleveland, OH 44195
  • Site Coordinator

    Brittany Hudson | 216-444-8230

    Principal Investigator

    Robert Tracy Ballock, MD (Spine)

  • Principal Investigator

    Surendrasingh Chhabada, MD (Cardiac)

Recruiting

Nemours / Alfred I. DuPont Hospital for Children
1600 Rockland Road, Wilmington, DE 19803
  • Principal Investigator

    Suken Shah, MD

Not Yet Recruiting

Duke University Medical Center
2301 Erwin Rd, Durham, NC 27710
  • Principal Investigator

    Brad Taicher, MD

Recruiting

Shriner’s Hospital
2211 N Oak Park Ave, Chicago, IL 60707
  • Principal Investigator

    Michal Szczodry, MD

Recruiting

If you have any questions for clinical trials, please contact clinicaltrials@pacira.com.