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MIRs 04 : Interpectoral Nerve Block With Ropivacaine Versus Placebo Before Breast Cancer Surgery

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ClinicalTrials.gov Identifier: NCT04327063
Recruitment Status : Not yet recruiting
First Posted : March 30, 2020
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm of Breast Drug: Saline Drug: Ropivacaine Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Placebo Comparator: Placebo
Saline (30 mL maximum)
Drug: Saline
Injection of the solution of 0.35 ml/kg of Saline not exceeding 30 mL of maximal volume.
Other Name: NA Cl 0.9%

Experimental: Ropivacaïne
Ropivacaïne 7.5 mg/mL (0.35 mL/kg of solution)
Drug: Ropivacaine
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 .

  2. 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)

  3. 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

  4. 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%

  5. 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

  6. 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

  7. 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

  8. 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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women with non-metastatic invasive breast carcinoma or breast carcinoma in situ treated by breast-conserving surgery (tumorectomy) with sentinel node technique on one day surgery.
  2. Age between 18 and 85 years.
  3. ASA class 1, 2 or 3
  4. Signed informed consent form.

Exclusion Criteria:

  1. Ongoing neoplasm or history of neoplasm other than breast cancer with the exception of: basal cell carcinoma, cervical carcinoma in situ, other treated cancer that has not relapsed during the 5 years preceding inclusion in the trial.
  2. Axillary dissection planned during surgery planning
  3. All bilateral surgery the day of Pecs administration
  4. Metastatic breast carcinoma at diagnosis (M1).
  5. Allergy to local anesthetics and morphine.
  6. Use of analgesics during the 12 hours preceding the surgical procedure.
  7. History of ipsilateral surgery during the previous 6 months.
  8. History of substance abuse.
  9. Pregnant woman or breastfeeding.
  10. Subjects deprived of their liberty or under guardianship (including temporary guardianship).
  11. Subjects no covered by social security scheme
  12. Experiencing any psychiatric condition or major cognitive impairment that may hamper completion of self-reported questionnaires.

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


Information from the National Library of Medicine

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


Contacts
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Contact: Aline ALBI-FELDZER, MD +33 1 47 11 15 15 aline.albi-feldzer@curie.fr
Contact: Anne-Sophie PLISSONNIER +33 1 47 11 23 78 drci.promotion@curie.fr

Locations
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France
Centre Jean Perrin
Clermont-Ferrand, France, 63000
Contact: Guillaume GAYRAUD, MD         
Principal Investigator: Guillaume GAYRAUD, MD         
Institut Curie
Paris, France, 75005
Contact: Aline ALBI-FELDZER, MD         
Sub-Investigator: ALBI-FELDZER, MD         
Hopital Tenon
Paris, France, 75020
Contact: Adrien LEMOINE, MD         
Principal Investigator: Adrien LEMOINE, MD         
Sponsors and Collaborators
Institut Curie
Investigators
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Study Director: Pierre FUMOLEAU, PhD Institut Curie
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT04327063    
Other Study ID Numbers: IC 2019-04
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Curie:
Surgery conservative
Nerve block
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents