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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
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:
The primary objective of the study is to measure plasma levels of bupivacaine following a pecto-intercostal fascial plane block (PIFB) in patients undergoing sternotomy for cardiac surgery.

Condition or disease Intervention/treatment
Pharmacokinetics Other: Collection of blood samples

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Study Type : Observational
Estimated Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring a pecto-intercostal fascial block following cardiac surgery
Criteria

Inclusion Criteria:

  • ASA l-lll
  • Undergoing sternotomy for cardiac surgery under a PIFB and general anesthesia

Exclusion Criteria:

  • Patient's refusal or inability to consent
  • Allergy, hypersensibility or resistance to local anesthetic
  • Contraindication to regional anesthesia: infection in the designated area, severe congenital coagulopathy or inadequate hemostasis before PIFB
  • Severe hepatic (Child B and C) or renal insufficiency (GFR<30 mL/min)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920904


Contacts
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Contact: Stephan Williams, MD, PhD 514-890-8000 ext 12132 stephanrwilliams@gmail.com
Contact: Monique Ruel, RN, CCRP 514-890-8000 ext 12171 monique.m.ruel.chum@ssss.gouv.qc.ca

Locations
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Canada, Quebec
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    stephanrwilliams@gmail.com   
Contact: Monique Ruel, RN, CCRP    514-890-8000 ext 12171    monique.m.ruel.chum@ssss.gouv.qc.ca   
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         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: Stephan Williams, MD, PhD Centre hospitalier de l'Université de Montréal (CHUM)
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03920904    
Other Study ID Numbers: 19.015
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No