Clinical trial NCT04827030: ER-One: A Double-blind Trial of Erector Spinae Block (ESP) Versus Paravertebral Block (PVB) Before Breast Cancer Surgery
Official title: A Double-blind Randomized Non-inferiority Trial of Erector Spinae Block (ESP) Versus Paravertebral Block (PVB) Before Breast Cancer Surgery: Effects on Acute Postoperative Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Surgery
Keywords: Breast
Surgery
anaesthetics
Lead sponsor: Institut Curie
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2021-04-01
Enrollment: 292
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Double-blind Randomized non-inferiority Trial of erector spinae block (ESP) versus paravertebral block (PVB)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Woman with breast adenocarcinoma without metastasis or breast in situ adenocarcinoma (with or without breast reconstruction by prosthesis) to by treated:

   * either by breast-conserving surgery with axillary dissection,
   * either by modified radical mastectomy with axillary dissection
   * either by modified radical mastectomy with lymph node dissection
   * either by modified radical mastectomy without axillary
2. Patients aged between 18 and 85 years old.
3. ASA class 1, 2 or 3 (Physical Status Classification System of American Society of Anesthesiologists (ASA)).
4. Signed informed consent form.
5. Patient able to answer self-assessment questionnaires (sufficient understanding of evaluations and in French).
6. Patient affiliated to the health care insurance.

Exclusion Criteria:

1. Preoperative consumption of opioid in the patient's current medications within three months before inclusion.
2. Ipsilateral breast surgery during 3 months prior to the inclusion.
3. Allergy to local anaesthetics and morphine and NSAID.
4. Local skin inflammation at the puncture area.
5. Bilateral breast surgery planned at inclusion.
6. Major immediate ipsilateral breast reconstruction by using tissue flap procedure (example: latissimus dorsi flap, Deep Inferior Epigastric Perforator (DIEP), Transverse Rectus Abdominis Musculocutaneous (TRAM)...).
7. Any contra-indication or patient's refusal for regional anesthesia.
8. Male subjects.
9. Pregnant woman or breastfeeding.
10. B blocker medication.
11. Patient already participating in an analgesia protocol that may interfere with the pain assessment criteria.
12. Patient under legal protection.
13. Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.

Primary outcomes:
measure: Comparison of ESP versus PVB on acute postoperative pain
timeFrame: 24 hours
Secondary outcomes:
measure: Postoperative morphine consumption
timeFrame: 2 hours
measure: Consumption of remifentanil in the Operating Room (OR)
timeFrame: During the period from the surgical incision to the end of the surgical dissection
measure: Acute early postoperative pain by Visual Analog Scale (VAS)
timeFrame: 24 hours
measure: Percentage of nausea or vomiting
timeFrame: 2 hours
measure: Incidence of complications and side effects of each block
timeFrame: 30 days
measure: Post-operative extend of dermatomes blocked
timeFrame: 2 hours
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Paris
country: France
facility: AP-HP Hôpital Tenon
city: Saint-Cloud
country: France
facility: Institut Curie
city: Toulouse
country: France
facility: Institut Claudius Régaud UICT
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut Curie
name: Pierre FUMOLEAU, PhD
role: STUDY_DIRECTOR
affiliation: Institut de Cancérologie de Lorraine
name: Julien RAFT, MD
role: PRINCIPAL_INVESTIGATOR
References: