PharmacokineticsNCT03920904
Peak Plasma Levels of Bupivacaine After a Pecto-Intercostal Fascial Block Post-Sternotomy for Cardiac Surgery
An observational study of Pharmacokinetics, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Collection of blood samples
- Type of treatment
- Injection or infusion
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jul 2019to 16 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring a pecto-intercostal fascial block following cardiac surgery
Who may be able to join
- ASA l-lll
- Undergoing sternotomy for cardiac surgery under a PIFB and general anesthesia
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
About this study
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.
Read the detailed description
Heart disease such as ischemic cardiomyopathy and heart failure are the second leading cause of death and a leading cause of hospitalization in Canada. Approximately 35,000 heart valve or coronary artery revascularization procedures involving median sternotomy, an important component in the treatment of these diseases, are performed annually. Median sternotomy is associated with acute pain that decreases patient satisfaction, increases the risk of delirium, arrhythmias and respiratory complications. It also contributes to the development of postoperative chronic pain that can affect up to 31% of patients in the first year after surgery. Multimodal analgesia, combining drug therapy and regional anesthesia, can help in preventing acute and perhaps chronic pain in patients undergoing sternotomy for cardiac surgery.
The pecto-intercostal fascial plane block (PIFB) is a new locoregional anesthesia technique that has emerged to treat pain following cardiac surgery including sternotomy, breast surgeries and sternal fractures. It consists of injecting local anesthetics in the space located between the major pectoralis muscle and the intercostal muscles using ultrasound guidance, allowing to obtain anesthesia of the territory innervated by the anterior cutaneous intercostal branches, i.e. the medial aspect of the breast and the sternum.
The dose of local anesthetic injected after a PIFB should aim to maximize analgesia while minimizing the chance of toxic systemic concentrations. Defining the rate of absorption of local anesthetics into the blood after a PIFB will therefore help anesthesiologists to determinate optimal analgesic doses, in terms of both safety and effectiveness.
This observational study will determine bupivacaine pharmacokinetics after a PIFB with bupivacaine, to further define the right dose and duration of surveillance in post-anesthesia care.
Methods: Anesthesia and cardiac surgery will be initiated as usual. The use of bupivacaine by the anesthesiologist or surgeon will be prohibited. Following closure of the sternum, while the patient remains intubated and ventilated under general anesthesia with monitoring, including invasive blood pressure, oxygen saturation, respiratory rate and ECG, the PIFB will be done before application of sternal dressing and removal of sterile fields. Using an ultrasound machine with a high frequency linear probe (Sonosite, HFL50 15-6MHz) placed in the parasagittal plane, 3cm away from the midline, the fascia between the major pectoralis muscle and the internal intercostal muscle will be visualized. Subsequently, four injection sites, defined by the space between the fascia of the pectoral and intercostal muscles at the third and sixth intercostal spaces on each side of the patient, will be reached with an insulated hyperechoic needle (50-80 mm, 22 gauge, SonoPlex STIM, Nanoline, Pajunk, Germany) inserted cephalically and positioned in-plane.
Following negative aspiration, the anesthesiologist will confirm the correct position of the needle with the fluid spread of 1 mL of 5% dextrose. Then, he will inject bupivacaine 0.25% with epinephrine 5 mcg/mL in 5 ml aliquots for a total dose of 2mg/kg of ideal body weight (maximum of 150mg or 60 mL).
The end of injection will be considered as T0. Collection of 4.5mL of blood will be performed at T10min, T20min, T30min, T45min, T60min, T90min, T120min, T180min, and T240min.
Blood tubes will be immediately placed on ice to be ultimately sent to the laboratory for centrifugation and measurement of bupivacaine level using liquid chromatography-tandem mass spectrometry (LC-MS/MS) for each of the samples.
After the block, the patient will be transferred to the Intensive Care Unit. At T240min, if the patient is extubated, the level of the sensory block will be identified by the pinprick test.
The time between ICU arrival and extubation, as well as the total consumption of opioids and co-analgesics for the first 24 hours will be recorded for each patient.
- Conditions
- Pharmacokinetics
- Being tested
- Collection of blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of blood samplesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Collection of blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 Tmax will be estimated by interpolation based on the plasmatic bupivacaine values obtained after the analysis of the blood samples.
Measured: 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
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.
Measured: 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 between the arrival of the patient in the Intensive Care Unit and the extubation of the patient will be measured in minutes.
Measured: 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
Sensory block level will be measured with a 6.1g von Frey filaments.
Measured: At T240 minutes (4 hours) after the end of injection, after the last sampling, at the Intensive Care Unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start29 Jul 2019
- Primary completion16 Sep 2019
- Study completion16 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Williams, MD, PhD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920904
- Sponsor's protocol ID
- 19.015
- Status last verified
- Jul 2021
- First submitted
- 16 Apr 2019
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peak Plasma Levels of Bupivacaine After a Pecto-Intercostal Fascial Block Post-Sternotomy for Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03920904
- Acronym / sponsor ID
- 19.015
- Conditions
- Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 16 Sep 2019 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Heart disease such as ischemic cardiomyopathy and heart failure are the second leading cause of death and a leading cause of hospitalization in Canada. Approximately 35,000 heart valve or coronary artery revascularization procedures involving median sternotomy, an important component in the treatment of these diseases, are performed annually. Median sternotomy is associated with acute pain that decreases patient satisfaction, increases the risk of delirium, arrhythmias and respiratory complications. It also contributes to the development of postoperative chronic pain that can affect up to 31% of patients in the first year after surgery. Multimodal analgesia, combining drug therapy and regional anesthesia, can help in preventing acute and perhaps chronic pain in patients undergoing sternotomy for cardiac surgery.
The pecto-intercostal fascial plane block (PIFB) is a new locoregional anesthesia technique that has emerged to treat pain following cardiac surgery including sternotomy, breast surgeries and sternal fractures. It consists of injecting local anesthetics in the space located between the major pectoralis muscle and the intercostal muscles using ultrasound guidance, allowing to obtain anesthesia of the territory innervated by the anterior cutaneous intercostal branches, i.e. the medial aspect of the breast and the sternum.
The dose of local anesthetic injected after a PIFB should aim to maximize analgesia while minimizing the chance of toxic systemic concentrations. Defining the rate of absorption of local anesthetics into the blood after a PIFB will therefore help anesthesiologists to determinate optimal analgesic doses, in terms of both safety and effectiveness.
This observational study will determine bupivacaine pharmacokinetics after a PIFB with bupivacaine, to further define the right dose and duration of surveillance in post-anesthesia care.
Methods: Anesthesia and cardiac surgery will be initiated as usual. The use of bupivacaine by the anesthesiologist or surgeon will be prohibited. Following closure of the sternum, while the patient remains intubated and ventilated under general anesthesia with monitoring, including invasive blood pressure, oxygen saturation, respiratory rate and ECG, the PIFB will be done before application of sternal dressing and removal of sterile fields. Using an ultrasound machine with a high frequency linear probe (Sonosite, HFL50 15-6MHz) placed in the parasagittal plane, 3cm away from the midline, the fascia between the major pectoralis muscle and the internal intercostal muscle will be visualized. Subsequently, four injection sites, defined by the space between the fascia of the pectoral and intercostal muscles at the third and sixth intercostal spaces on each side of the patient, will be reached with an insulated hyperechoic needle (50-80 mm, 22 gauge, SonoPlex STIM, Nanoline, Pajunk, Germany) inserted cephalically and positioned in-plane.
Following negative aspiration, the anesthesiologist will confirm the correct position of the needle with the fluid spread of 1 mL of 5% dextrose. Then, he will inject bupivacaine 0.25% with epinephrine 5 mcg/mL in 5 ml aliquots for a total dose of 2mg/kg of ideal body weight (maximum of 150mg or 60 mL).
The end of injection will be considered as T0. Collection of 4.5mL of blood will be performed at T10min, T20min, T30min, T45min, T60min, T90min, T120min, T180min, and T240min.
Blood tubes will be immediately placed on ice to be ultimately sent to the laboratory for centrifugation and measurement of bupivacaine level using liquid chromatography-tandem mass spectrometry (LC-MS/MS) for each of the samples.
After the block, the patient will be transferred to the Intensive Care Unit. At T240min, if the patient is extubated, the level of the sensory block will be identified by the pinprick test.
The time between ICU arrival and extubation, as well as the total consumption of opioids and co-analgesics for the first 24 hours will be recorded for each patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine dosage in PIFB block | – | Other: Collection of blood samplesThe 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring a pecto-intercostal fascial block following cardiac surgery
Key inclusion criteria (2 listed)
- ASA l-lll
- Undergoing sternotomy for cardiac surgery under a PIFB and general anesthesia
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of blood samplesNine 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. | Other | Bupivacaine dosage in PIFB block |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Williams, MD, PhD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacokinetics, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.