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

Cardiac Conditions Clinical Trial

— CohortI-II  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04685421
• Other study ID #: 2020005RI
• Status: Terminated
• Phase: Phase 1
• Start date: July 15, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: Nicklaus Children's Hospital f/k/a Miami Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Conditions
• Surgical Wound

Intervention

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

Locations

Country	Name	City	State
United States	Nickalus Children's Hospital f/k/a Miami Children's Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Nicklaus Children's Hospital