Nervous Block erector spinae plane (ESP) or paravertebral block (PVB) preoperatively in women with breast adenocarcinoma without metastasis or breast in situ adenocarcinoma to by treated either by breast-conserving surgery with axillary dissection, either by modified radical mastectomy with or without axillary or lymph node dissection. MedDRA version: 20.1 Level: LLT Classification code 10003034 Term: Application site anesthesia System Organ Class: 100000004867 MedDRA version: 20.0 Level: HL
Conditions
Interventions
Product Code: Chlorhydrate de Ropivacaïne
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ROPIVACAINE
CAS Number: 84057-95-4
Other descriptive name: Chlorhydrate de Ropivacaïne
Concen
Sponsors
INSTITUT CURIE
Eligibility
Sex/Gender
All
Inclusion 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. There is no prohibition for people to take part simultaneously in another research and there is no exclusion cause at the end of the research period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 192 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1.Preoperative consumption of opioid in the patient's current médications 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, DIEP, 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 deprived of liberty or under legal protection. 13.Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the percentage of patients needed morphine with ESP block or PVB during the first two postoperative hours in the Post-Anesthesia Care Unit (PACU).;Secondary Objective: 1.Evaluation of the total morphine consumption (IV titration in mg) in the PACU. 2.Evaluation of the consumption of Remifentanil in the Operating Room in µg during the period from incision to the last stitch . 3.Evaluation of the Visual Analogic Scale (VAS) (no pain=0, worst pain=10): VAS at arrival in the PACU, VAS every 30 min in the PACU, VAS at 4 and 24 hours. Pain scores will be evaluated at rest and after shoulder movement. 4.Percentage of patients with nausea or vomiting over 24 hours. 5.Evaluation of the complications and side effects of each block. 6.Post-operative distribution of diminished cold sensation on the nipple line (ice cube test) in the PACU. 7.Evaluation of postoperative quality of recovery score: the QoR-15 before surgery and 24h after surgery 8.Anaesthesiologist & patient satisfaction after regional anesthesia technique with a scale from 0 to 10 (not at all satisfactory=0; very satisfactory=10). 9.Consumption of antalgic drugs over 24 hours. ;Primary end point(s): The main hypothesis of this study is to demonstrate that the percentage of patients needed morphine during the first two postoperative hours in the ESP group is no worse than in the PVB group by more than 20%. The rational to choose this objective as primary objective is to show a non-inferiority of ESP versus PVB on acute postoperative pain. ;Timepoint(s) of evaluation of this end point: Primary end point : 2 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Postoperative morphine consumption: the rational for this objective is to show the efficacy of ESP block in breast surgery according low consumption of opioid, thus improving the patients’ pain outcomes and the related side effects. 2.Consumption of remifentanil in the Operating Room (OR) in µg during the period from the surgical incision to the end of the surgical dissection (consumption of remifentanil during this period / patient weight / duration of the period). 3.Acute early postoperative pain at rest. The rational for such an objective is to show efficacy of the ESP block on breast surgery. The pain will be assessed by the Visual Analogic Scale (VAS) (no pain=0, worst pain=10): VAS at arrival in the PACU, VAS every 30 minutes in the PACU, VAS at 4 and 24 hours. Pain scores will be evaluated at rest and after shoulder movement. 4.Percentage of nausea or vomiting in patients over 24 hours: the rational for this objective is to show the efficacy low consumption of opioid, thus improving the patients’ related side effects. 5.Complications and side effects of each block. 6.Post-operative distribution of diminished cold sensation on the nipple line (ice cube test) in the PACU. 7.Evaluation of postoperative quality of recovery score: the QoR-15 before surgery and 24 hours after surgery. Quality of recovery after anesthesia is an important measure of the early postoperative health status of patients. The QoR-15 provides a valid evaluation of this recovery. The validation of the French version of the scale is published. 8.Anaesthesiologist (conditions for performing the block) and patient (pain) satisfaction just after regional anesthesia technique with a scale from 0 to 10 (not at all satisfactory=0; very satisfactory=10). 9.Total dose of antalgic drugs (over 24 hours).;Timepoint(s) of evaluation of this end point: 1.Postoperative morphine consumption: 2 hours 2.Consumption of remifentanil: during the period from the surgical incisi | — |
Countries
France
Contacts
Public ContactIsabelle TURBIEZ
INSTITUT CURIE
Outcome results
None listed