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PI, Christopher Tirotta, no longer at NCH as of 5-26-23.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine PK | Experimental | Liposomal Bupivacaine PKs collections up to 96 hours on children from 2 to 17 years in pediatric cardiac surgeries. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine liposome | Drug | Liposomal Bupivacaine PKs collections up to 96 hours on children from 2 to 17 years in pediatric cardiac surgeries. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher F Tirotta, MD | Nicklaus Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nickalus Children's Hospital f/k/a Miami Children's Hospital | Miami | Florida | 33155 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32324672 | Background | 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. | |
| 32195834 |
| Label | URL |
|---|---|
| Nicklaus Children's Hospital | View source |
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De-identified will be posted in website.
one year after study closure
Information will be provided by request to the PI
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 12, 2024 | |
| Reset | Jan 2, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 12, 2024 | Jan 2, 2025 |
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)
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| 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. |
| 30521078 | 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. |
| 30207019 | 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. |