MIRs 04 : Interpectoral Nerve Block With Ropivacaine Versus Placebo Before Breast Cancer Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04327063|
Recruitment Status : Not yet recruiting
First Posted : March 30, 2020
Last Update Posted : April 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm of Breast||Drug: Saline Drug: Ropivacaine||Phase 3|
Before surgery, the 3rd interpectoral space will be identified. After aspiration, half of the solution of 0.35 ml/kg of Ropivacaine 7.5 mg/ml not exceeding 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 (Clinical Trial)|
|Estimated Enrollment :||182 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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)|
|Estimated Study Start Date :||June 15, 2020|
|Estimated Primary Completion Date :||June 15, 2022|
|Estimated Study Completion Date :||October 15, 2022|
Placebo Comparator: Placebo
Saline (30 mL maximum)
Injection of the solution of 0.35 ml/kg of Saline not exceeding 30 mL of maximal volume.
Other Name: NA Cl 0.9%
Ropivacaïne 7.5 mg/mL (0.35 mL/kg of solution)
Injection of the solution of 0.35 ml/kg of Ropivacaine 7.5 mg/ml not exceeding 30 mL of maximal volume.
Other Name: Naropeine
- 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 [ 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
- Evaluation of acute pain at rest and after shoulder movement until 48 postoperative hours [ 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 .
- Evaluation of acute pain until 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)
- Evaluation of patient's satisfaction on pain management [ 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
- Evaluation of Remifentanil consumption during anesthesia [ Time Frame: 3 hours ]Total dose of Remifentanil during anesthesia for a bispectral index between 40-60 or Analgesia Nociception Index (ANI) > 60%
- Evaluation of analgesic consumption during the first 48 postoperative hours [ Time Frame: 48 hours ]Consumption of Paracetamol and Ketoprofene in systematic, Tramadol and Nefopam if VAS>3 and Morphine if VAS >5 during 48 postoperative hours
- Evaluation of the incidence of nausea and vomiting during the first 48 postoperative hours [ Time Frame: 48 hours ]Incidence of nausea and vomiting during the first 48 postoperative hours
- Evaluation of complications of Pecs during 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
- Evaluation of the incidence of serious adverse events during 30 days [ Time Frame: 30 days ]Number of serious adverse events during 30 days after Pecs administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04327063
|Contact: Aline ALBI-FELDZER, MD||+33 1 47 11 15 firstname.lastname@example.org|
|Contact: Anne-Sophie PLISSONNIER||+33 1 47 11 23 email@example.com|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63000|
|Contact: Guillaume GAYRAUD, MD|
|Principal Investigator: Guillaume GAYRAUD, MD|
|Paris, France, 75005|
|Contact: Aline ALBI-FELDZER, MD|
|Sub-Investigator: ALBI-FELDZER, MD|
|Paris, France, 75020|
|Contact: Adrien LEMOINE, MD|
|Principal Investigator: Adrien LEMOINE, MD|
|Study Director:||Pierre FUMOLEAU, PhD||Institut Curie|