Saline
DrugInjection of the solution of Saline not exceeding 30 mL of maximal volume.
Other names: NA Cl 0.9%
NCT Number: NCT04327063
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.
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Notify Me18 year–85 year
Female
Interventional
Phase 3
Centre Jean Perrin, Clermont-Ferrand, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
There is no prohibition for people to take part simultaneously in another search and there is no exclusion cause at the end of the research period
Injection of the solution of Saline not exceeding 30 mL of maximal volume.
Other names: NA Cl 0.9%
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
Other names: Naropeine
Time frame: 3 hours
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: 48 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
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
Scale of satisfaction ( 0 to 10 : 0 = very bad and 10 = excellent) of the pain management at 48 post-operative hours
Time frame: 3 hours
Total dose of Remifentanil during anesthesia for a bispectral index between 40-60 or Analgesia Nociception Index (ANI) > 60%
Time frame: 48 hours
Consumption of Ketoprofene in systematic, Paracetamol if VAS>3 and Tramadol if analgesia is not enough during 48 postoperative hours
Time frame: 48 hours
Incidence of nausea and vomiting during the first 48 postoperative hours
Time frame: 48 hours
Complications of Pecs block: pneumothorax, nerve injury, hypotension, vascular puncture and systemic toxicity of local anaesthetic (seizures, etc.) collected
Time frame: 30 days
Number of serious adverse events during 30 days after Pecs administration
Institut Curie
Other
A Double-blind Randomized Trial of Interpectoral Nerve Block (Pecs 1 and 2) With Ropivacaine Versus Placebo Before Breast Cancer Surgery: Effects on Acute Postoperative Pain. (MIRs 04)
Acronym: MIRs 04
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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