Back to resultsLiposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery (CohortI-II)
Primary Purpose
Cardiac Conditions
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine liposome
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Conditions focused on measuring pediatric cardiac surgery, median sternotomy incision
Eligibility Criteria
Inclusion Criteria:
- Every elective pediatric surgery patient ages two through seventeen years old, inclusive.
Exclusion Criteria:
- 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.
Sites / Locations
- Nickalus Children's Hospital f/k/a Miami Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Liposomal Bupivacaine PK
Arm Description
Liposomal Bupivacaine PKs collections up to 96 hours on children from 2 to 17 years in pediatric cardiac surgeries.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04685421
First Posted
December 22, 2020
Last Updated
June 1, 2023
Sponsor
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04685421
Brief Title
Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery
Acronym
CohortI-II
Official Title
Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
PI, Christopher Tirotta, no longer at NCH as of 5-26-23.
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
To determine the pharmacokinetic profile and peak bupivacaine plasma concentration with the use of an Exparel/bupivacaine mixture in children ages two through seventeen (Cohort I). Cohort II covers ages 2 <6. We will be collecting blood samples at different times during 96 hours or until the patient is discharged from the hospital. There will be two different groups participating in the study alternating the times in which the blood samples will be collected. We hypothesize that peak plasma concentration will be significantly less than the toxic plasma concentration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Conditions
Keywords
pediatric cardiac surgery, median sternotomy incision
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
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)
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liposomal Bupivacaine PK
Arm Type
Experimental
Arm Description
Liposomal Bupivacaine PKs collections up to 96 hours on children from 2 to 17 years in pediatric cardiac surgeries.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine liposome
Other Intervention Name(s)
Bupivacaine liposome PKs
Intervention Description
Liposomal Bupivacaine PKs collections up to 96 hours on children from 2 to 17 years in pediatric cardiac surgeries.
Primary Outcome Measure Information:
Title
Bupivacaine-Exparel levels
Description
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.
Time Frame
96 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Every elective pediatric surgery patient ages two through seventeen years old, inclusive.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher F Tirotta, MD
Organizational Affiliation
Nicklaus Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nickalus Children's Hospital f/k/a Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified will be posted in website.
IPD Sharing Time Frame
one year after study closure
IPD Sharing Access Criteria
Information will be provided by request to the PI
Citations:
PubMed Identifier
32324672
Citation
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.
Results Reference
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PubMed Identifier
32195834
Citation
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.
Results Reference
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PubMed Identifier
30521078
Citation
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.
Results Reference
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PubMed Identifier
30207019
Citation
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.
Results Reference
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Links:
URL
http://www.nicklauschildrens.org
Description
Nicklaus Children's Hospital
Learn more about this trial
Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery
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