Peak Plasma Levels of Bupivacaine After a Pecto-Intercostal Fascial Block Post-Sternotomy for Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT03920904|
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : August 27, 2020
|Condition or disease||Intervention/treatment|
|Pharmacokinetics||Other: Collection of blood samples|
|Study Type :||Observational|
|Estimated Enrollment :||18 participants|
|Official Title:||Peak Plasma Levels of Bupivacaine After a Pecto-Intercostal Fascial Block Post-Sternotomy for Cardiac Surgery|
|Actual Study Start Date :||July 29, 2019|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 2, 2021|
Bupivacaine dosage in PIFB block
The pharmacokinetics of bupivacaine 0.25% with epinephrine 5 mcg/mL for a total dose of 2mg/kg of ideal body weight following a PIFB block will be determined by the collection of blood samples at predetermined time points.
Other: Collection of blood samples
Nine blood samples will be collected to determine bupivacaine pharmacokinetics at T10min, T20min, T30min, T45min, T60min, T90min, T120min, T180min, and T240min. T0 will be defined as the end of bupivacaine injection.
- Maximal plasma concentration (Cmax) of bupivacaine after pecto-intercostal fascial plane block [ Time Frame: The end of injection of bupivacaine will be considered as T0. Blood samples at T10, T20, T30, T45, T60, T90, T120, T180, and T240minutes will be collected to further analyze plasmatic bupivacaine values at these timepoints. ]The Cmax will be estimated by interpolation based on the plasmatic bupivacaine values obtained after the analysis of the blood samples.
- Time (Tmax) to maximum plasma concentration Cmax of bupivacaine [ Time Frame: The end of injection of bupivacaine will be considered as T0. Blood samples at T10, T20, T30, T45, T60, T90, T120, T180, and T240 minutes will be performed to further analyze plasmatic bupivacaine values at these timepoints. ]The Tmax will be estimated by interpolation based on the plasmatic bupivacaine values obtained after the analysis of the blood samples.
- Total opioid and co-analgesics doses needed in the Intensive Care Unit [ Time Frame: After the surgery, from the arrival in the Intensive Care Unit to 24 hours after the entry in the Intensive Care Unit. ]The total dose of opioids and co-analgesics used by the patients during the first 24 hours in the Intensive Care Unit will be recorded.
- Time between arrival in Intensive Care Unit and extubation [ Time Frame: Time from the arrival in the Intensive Care Unit to the extubation, for an average of 4 hours following surgery. ]Time between the arrival of the patient in the Intensive Care Unit and the extubation of the patient will be measured in minutes.
- Sensory block level during the last sampling [ Time Frame: At T240 minutes (4 hours) after the end of injection, after the last sampling, at the Intensive Care Unit ]Sensory block level will be measured with a 6.1g von Frey filaments.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920904
|Contact: Stephan Williams, MD, PhD||514-890-8000 ext firstname.lastname@example.org|
|Contact: Monique Ruel, RN, CCRP||514-890-8000 ext email@example.com|
|Centre Hospitalier de l'Université de Montréal (CHUM)||Recruiting|
|Montréal, Quebec, Canada, H2X 3E4|
|Contact: Stephan R Williams, Md, PhD 514-890-8000 ext 12132 firstname.lastname@example.org|
|Contact: Monique Ruel, RN, CCRP 514-890-8000 ext 12171 email@example.com|
|Sub-Investigator: Sophie Ayoub, MD|
|Sub-Investigator: Pierre-Olivier Hétu, PhD, CSPQ|
|Sub-Investigator: Sarah Maximos, MD|
|Sub-Investigator: Alex Moore, MD, FRCPC|
|Sub-Investigator: Louis-Mathieu Stevens, MD, FRCSC|
|Principal Investigator:||Stephan Williams, MD, PhD||Centre hospitalier de l'Université de Montréal (CHUM)|