The block (ESP or PVB) will be performed preoperatively in the recovery room under standard monitoring. After setting a peripheral venous access, patient will be installed on lateral decubitus position on the opposite side of the block.
The block will be performed with IV Remifentanil sedation Target-Controlled Infusion mode at 2ng/ml and oxygen therapy. For the erector spinae plane block: The puncture will be performed with ultrasound guidance. The ultrasound probe will be placed parallel to the spine parasagittally at the T3 transverse process level. The needle will be introduced and visualized to the plane of the ultrasound image ("in plane"). The desired injection site is between the fascia of the erector muscle of the spine and the transverse process at the T3 level. The operator ensures the correct localization of the needle with saline solution. Then 0.50% Ropivacaine hydrochloride will be injected at a dose of 0.6 ml/kg of actual weight, without exceeding 30 ml. For paravertebral block: The T2 intervertebral space will be located by identifying compared to C7, a prominent cervical vertebra, or by ultrasound by counting the thoracic vertebrae from the first rib. The paravertebral space will be identified by placing the ultrasound probe in a parasagittal or transverse position. The needle will go through the paravertebral muscles and the costo-transverse ligament or by a latero-medial approach using ultrasound. The block will be performed using a 22-gauge 8cm long needle. When the paravertebral space has been reach, an aspiration test will be performed and then 0.6 ml/kg of solution (Ropivacaine hydrochloride solution at 5 mg/ml up to 30 ml) will be injected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
292
Ropivacaïne Hydrochloride Erector Spinae puncture will be performed with ultrasound guidance. Then 0.50% Ropivacaine hydrochloride will be injected at a dose of 0.6 ml/kg of actual weight, without exceeding 30 ml.
Paravertebral puncture will be performed with ultrasound guidance. Then 0.50% Ropivacaine hydrochloride will be injected at a dose of 0.6 ml/kg of actual weight, without exceeding 30 ml.
Centre Jean Perrin
Clermont-Ferrand, France
AP-HP Hôpital Tenon
Paris, France
Institut Curie
Saint-Cloud, France
Institut Claudius Régaud UICT
Toulouse, France
Institut de Cancérologie de Lorraine
Comparison of ESP versus PVB on acute postoperative pain
Percentage of patients needed morphine during the first two postoperative hours in each treatment arm
Time frame: 24 hours
Postoperative morphine consumption
Dose of opioid, in the Post-Anesthesia Care Unit (PACU)
Time frame: 2 hours
Consumption of remifentanil in the Operating Room (OR)
Dose of Remifentanil during the Operating Room (OR) period
Time frame: During the period from the surgical incision to the end of the surgical dissection
Acute early postoperative pain by Visual Analog Scale (VAS)
VAS (no pain=0, worst pain=10) at arrival in the PACU, every 30 minutes in the Post-Anaesthesia Care Unit (PACU), VAS at 4 and 24 hours. Pain scores will be evaluated at rest and after shoulder movement
Time frame: 24 hours
Percentage of nausea or vomiting
Number of patient who related nausea or vomiting side effects will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0)
Time frame: 2 hours
Incidence of complications and side effects of each block
Complications and side effects of each block will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0)
Time frame: 30 days
Post-operative extend of dermatomes blocked
The extent of dermatomes blocked as measured by clinical examination to determine area where temperature perception change
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Vandœuvre-lès-Nancy, France
Time frame: 2 hours