Compare the effect of ropivacaine versus placebo pectoral nerve block (Pecs 1 and 2) on acute pain after tumorectomy plus sentinel lymph node dissection on one day surgery.
Before surgery, the 3rd interpectoral space will be identified. After aspiration, half of the solution of Ropivacaine 5 mg/ml not exceeding 3 mg/kg of maximal dose and 30 ml of maximal volume or saline (not exceeding 30 ml of maximal volume) will be injected into the interpectoral space underneath the pectoralis major muscle for the Pecs 1 block. The other half of the solution will be injected above the serratus anterior muscle at the third rib. Evaluation of the percentage of patients treated with step 2 or 3 analgesics during the three postoperative hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
182
Injection of the solution of Saline not exceeding 30 mL of maximal volume.
Dilution of Ropivacaine 7.5 mg/ml to 5 mg/ml not to exceed 3 mg/kg of maximal dose and 30 ml of maximal volume
Centre Jean Perrin
Clermont-Ferrand, France
Institut Curie
Paris, France
Hopital Tenon
Paris, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
To compare the effect of ropivacaine versus placebo pectoral nerve block (Pecs 1 and 2) on acute pain after tumorectomy plus sentinel lymph node dissection on one day surgery
Percentage of patients treated with step 2 or 3 analgesics during the first three postoperative hours after tumorectomy plus sentinel lymph node dissection, between the group with Ropivacaïne and the group with placebo
Time frame: 3 hours
Evaluation of acute pain at rest and after shoulder movement until 48 postoperative hours
VAS Scale (0 to 10 : 0 = no pain and 10 = Worst pain possible) at rest and after shoulder movement every 30 minutes during the first three postoperative hours in the PACU and the day surgery unit and then at home every 6 hours for the first 48 postoperative hours .
Time frame: 48 hours
Evaluation of acute pain until 48 postoperative hours
Brief Pain Inventory Questionnaires at 48 hours will be collected with VAS Scale (0 to 10 : 0 = no pain and 10 = Worst pain possible)
Time frame: 48 hours
Evaluation of patient's satisfaction on pain management
Scale of satisfaction ( 0 to 10 : 0 = very bad and 10 = excellent) of the pain management at 48 post-operative hours
Time frame: 48 hours
Evaluation of Remifentanil consumption during anesthesia
Total dose of Remifentanil during anesthesia for a bispectral index between 40-60 or Analgesia Nociception Index (ANI) \> 60%
Time frame: 3 hours
Evaluation of analgesic consumption during the first 48 postoperative hours
Consumption of Ketoprofene in systematic, Paracetamol if VAS\>3 and Tramadol if analgesia is not enough during 48 postoperative hours
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Time frame: 48 hours
Evaluation of the incidence of nausea and vomiting during the first 48 postoperative hours
Incidence of nausea and vomiting during the first 48 postoperative hours
Time frame: 48 hours
Evaluation of complications of Pecs during 48 postoperative hours
Complications of Pecs block: pneumothorax, nerve injury, hypotension, vascular puncture and systemic toxicity of local anaesthetic (seizures, etc.) collected
Time frame: 48 hours
Evaluation of the incidence of serious adverse events during 30 days
Number of serious adverse events during 30 days after Pecs administration
Time frame: 30 days