Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery

NCT04685421 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 2020005RI
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the plasma concentration of bupivacaine at various time points after Exparel (bupivacaine liposome injectable suspension, Pacira Pharmaceuticals, Inc., Parsippany, NJ) is injected subcutaneously for median sternotomy incisions in pediatric cardiac surgery patients.

Conditions

Cardiac Conditions

Keywords

pediatric cardiac surgery; median sternotomy incision

Outcome Measures

Primary Outcomes (1)

• Bupivacaine-Exparel levels

  To determine plasma bupivacaine levels after the use of Exparel 1.3% admixed with 0.25% bupivacaine and 0.9% Normal Saline in pediatric cardiac surgery patients ages two through seventeen years of age (Cohort I). Cohort II covers ages 2 \< 6.

  96 hours

Study Arms (1)

Liposomal Bupivacaine PK

EXPERIMENTAL

Liposomal Bupivacaine PKs collections up to 96 hours on children from 2 to 17 years in pediatric cardiac surgeries.

Drug: Bupivacaine liposome

Interventions

Bupivacaine liposome DRUG

Liposomal Bupivacaine PKs collections up to 96 hours on children from 2 to 17 years in pediatric cardiac surgeries.

Also known as: Bupivacaine liposome PKs

Liposomal Bupivacaine PK

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Every elective pediatric surgery patient ages two through seventeen years old, inclusive.

You may not qualify if:

• Patients who fall outside of the age range for the study will be excluded. -Patients known to have had an anaphylactic or severe reaction to the drug or its components will not be enrolled. Any with Significant Liver Disease will also be excluded. Emergency patients will be excluded. Pregnant patients will be excluded.

Sponsors & Collaborators

• Nicklaus Children's Hospital f/k/a Miami Children's Hospital: lead

Study Sites (1)

Nickalus Children's Hospital f/k/a Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Related Publications (4)

• Chughtai M, Sultan AA, Hudson B, Goodwin RC, Seif J, Khlopas A, Bena J, Jin Y, Gurd DP, Kuivila TE, Ballock RT. Liposomal Bupivacaine Is Both Safe and Effective in Controlling Postoperative Pain After Spinal Surgery in Children: A Controlled Cohort Study. Clin Spine Surg. 2020 Dec;33(10):E533-E538. doi: 10.1097/BSD.0000000000000996.

  PMID: 32324672 BACKGROUND

• Crowley JS, McLean P, Gabriel RA, Cronin B, Hsieh S, Englar K, Said E, Lance S, Gosman A. The Association of Liposomal Bupivacaine on Opioid Consumption in the Pediatric Alveolar Cleft Population. J Craniofac Surg. 2020 Jun;31(4):1078-1081. doi: 10.1097/SCS.0000000000006310.

  PMID: 32195834 BACKGROUND

• Cohen B, Glosser L, Saab R, Walters M, Salih A, Zafeer-Khan M, Rivas E, Zhang K, Schacham NY, Chodavarapu P, Essber H, Chelnick D, Raza S, Hanline C, Khoshknabi D, Yang D, Seif J, Chhabada S, Turan A. Incidence of adverse events attributable to bupivacaine liposome injectable suspension or plain bupivacaine for postoperative pain in pediatric surgical patients: A retrospective matched cohort analysis. Paediatr Anaesth. 2019 Feb;29(2):169-174. doi: 10.1111/pan.13561. Epub 2018 Dec 31.

  PMID: 30521078 BACKGROUND

• Cloyd C, Moffett BS, Bernhardt MB, Monico EM, Patel N, Hanson D. Efficacy of liposomal bupivacaine in pediatric patients undergoing spine surgery. Paediatr Anaesth. 2018 Nov;28(11):982-986. doi: 10.1111/pan.13482. Epub 2018 Sep 11.

  PMID: 30207019 BACKGROUND

Related Links

• Nicklaus Children's Hospital

Study Officials

• Christopher F Tirotta, MD

  Nicklaus Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Regulatory Affairs

Model Details: Study population of 30 pediatric cardiac surgery patients (ages 2 to 17\_cohort I) undergoing elective operations between the ages of two through seventeen years. Cohort II (Ages 2 \< 6)

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: July 15, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: one year after study closure
• Access Criteria: Information will be provided by request to the PI

Locations

US (1)