Clinical trial NCT04685421: Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery
Official title: Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cardiac Conditions
Keywords: pediatric cardiac surgery
median sternotomy incision
Lead sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 15
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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)
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Bupivacaine-Exparel levels
timeFrame: 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Nickalus Children's Hospital f/k/a Miami Children's Hospital
state: Florida
Study officials:
affiliation: Nicklaus Children's Hospital
name: Christopher F Tirotta, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.