Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03920904 |
| Other study ID # |
19.015 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 29, 2019 |
| Est. completion date |
September 16, 2019 |
Study information
| Verified date |
July 2021 |
| Source |
Centre hospitalier de l'Université de Montréal (CHUM) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
