Peak Plasma Levels of Bupivacaine After a Pecto-Intercostal Fascial Block Post-Sternotomy for Cardiac Surgery

NCT03920904 | Completed

• 1 other identifier: 19.015
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Maximal plasma concentration (Cmax) of bupivacaine after pecto-intercostal fascial plane block

  The Cmax will be estimated by interpolation based on the plasmatic bupivacaine values obtained after the analysis of the blood samples.

  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.

Secondary Outcomes (4)

• Time (Tmax) to maximum plasma concentration Cmax of bupivacaine

  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.

• Total opioid and co-analgesics doses needed in the Intensive Care Unit

  After the surgery, from the arrival in the Intensive Care Unit to 24 hours after the entry in the Intensive Care Unit.

• Time between arrival in Intensive Care Unit and extubation

  Time from the arrival in the Intensive Care Unit to the extubation, for an average of 4 hours following surgery.

• Sensory block level during the last sampling

  At T240 minutes (4 hours) after the end of injection, after the last sampling, at the Intensive Care Unit

Study Arms (1)

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

Interventions

Collection of blood samples OTHER

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.

Bupivacaine dosage in PIFB block

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring a pecto-intercostal fascial block following cardiac surgery

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Study Officials

• Stephan Williams, MD, PhD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 19, 2019
• Study Start: July 29, 2019
• Primary Completion: September 16, 2019
• Study Completion: September 16, 2019
• Last Updated: July 2, 2021

Record last verified: 2021-07

Locations

CA (1)