MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery (MIRs03)

July 9, 2019 updated by: Institut Curie

MIRs03: A Double-blind Randomized Trial of Paravertebral Block With Ropivacaine Before Breast Cancer Surgery: Effects on Chronic Postoperative Pain

Compare the effect of paravertebral block (PVB) with Ropivacaine or placebo on the incidence of chronic pain 3 months after breast cancer surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Before anesthesia, the second or third intercostal space is located. After an aspiration, 0.35 mL/kg of solution (ropivacaine 7.5 mg/mL or saline, maximum 30 mL) are injected into the paravertebral space. After 30 minutes, spread of PVB is evaluated by cold test on skin. Then, general anesthesia is induced.

Evaluation of the frequency of chronic pain at 3, 6 and 12 months by the Brief Pain Inventory (BPI) questionnaire and Neuropathic Pain Diagnostic (DN4) and Anxiety and depression evaluation by the Hospital Anxiety and Depression questionnaire (HAD) will be done.

Study Type

Interventional

Enrollment (Actual)

380

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont Ferrand, France, 63011
        • Centre Jean Perrin
      • Lyon, France, 69008
        • Centre Leon Berard
      • Nice, France, 06189 NICE Cedex
        • Centre Antoine Lacassagne
      • Paris, France, 75005
        • INSTITUT CURIE - Site Paris
      • Saint Cloud, France, 92210
        • Institut Curie Site Saint-Cloud
      • Vandoeuvre-les-nancy, France, 54511
        • Institut de Cancerologie de Lorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women with non-metastatic invasive breast carcinoma or breast carcinoma in situ treated by:

    • either breast-conserving surgery with axillary lymph node dissection
    • either radical surgery with or without axillary lymph node dissection.
  2. 18 years ≤ Age ≥ 85 years.
  3. ASA class 1, 2 or 3.
  4. No analgesic treatment for 2 days (no pre-existing chronic pain)
  5. If a biological control has been requested recently or deemed necessary by the Investigator, then it should be satisfactory : Adequate hematologic and hemostasis: neutrophil count (ANC) > 1500/mm3, haemoglobin > 9 g/dl and platelets > 75 000/mm3, prothrombin time > 70%, activated partial thromboplastin time < 1.5 X Upper Limit of Normal (ULN)
  6. Life expectancy ≥ 2 years.
  7. Signed informed consent form.
  8. Patient able to meet the self-assessments questionnaires (sufficient understanding assessments, proficiency in French)
  9. Patient affiliated with a health insurance scheme (beneficiary or legal)

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.

Exclusion Criteria:

  1. Ongoing neoplasm or history of malignancy 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. Bilateral breast carcinoma at the inclusion
  3. Male subjects.
  4. Metastatic breast carcinoma at diagnosis (M1).
  5. Severe heart, liver and respiratory failure (ASA 4)
  6. Allergy to local anesthetics and morphine.
  7. Use of analgesics during the 48 hours preceding the surgical procedure.
  8. History of breast surgery with painful sequelae
  9. Major deformation of the spine
  10. Puncture site infection
  11. History of substance abuse.
  12. Pregnant or lactating women, or women of childbearing potential without effective contraception
  13. Subjects deprived of their liberty or under guardianship (including temporary guardianship).
  14. Subjects unable to comply with medical follow-up of the trial for geographical, social or psychological reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Saline (30 mL maximum)
Drug: Saline
Other Names:
  • NA Cl 0.9%
Experimental: Ropivacaine
Ropivacaine 7.5 mg/mL (0.35 mL/kg of solution)
Drug: Ropivacaine
Other Names:
  • Naropeine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare chronic pain 3 months after breast surgery in each arm
Time Frame: 3 months
Percentage of patients who reported chronic pain 3 months after breast surgery in each arm evaluated by the Brief Pain Inventory, French version. Chronic pain is defined by the item 5 of BPI (upper or equal to 3)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the extend of dermatomes blocked
Time Frame: one year after surgery
The extent of dermatomes blocked as measured by clinical examination to determine area where temperature perception change
one year after surgery
To measure acute postoperative pain (Visual Analog Scale (VAS)
Time Frame: 48 postoperative hours
Patient satisfaction on Visual Analog Scale (VAS)
48 postoperative hours
To determine analgesic consumption
Time Frame: 48 postoperative hours
consumption during the first 48 postoperative hours: morphine paracetamol and ketoprofen
48 postoperative hours
To examine incidence of nausea and vomiting
Time Frame: 48 postoperative hours
Common Toxicity Criteria for Adverse Effects (CTCAE) V4.03
48 postoperative hours
To characterize chronic pain (Neuropathic Pain Diagnostic DN4 Questionnaire)
Time Frame: 3 months
Neuropathic Pain Diagnostic DN4 Questionnaire
3 months
To evaluate the frequency of chronic pain (BPI questionnaire and Neuropathic Pain Diagnostic (DN4)
Time Frame: 6 and 12 months
BPI questionnaire and Neuropathic Pain Diagnostic (DN4)
6 and 12 months
To compare presence of lymphedema
Time Frame: 3, 6 and 12 months
Clinical examination
3, 6 and 12 months
To evaluate anxiety and depression evaluation (Hospital Anxiety and Depression questionnaire (HAD)
Time Frame: 3, 6 and 12 months
Hospital Anxiety and Depression questionnaire (HAD)
3, 6 and 12 months
To evaluate complications of paravertebral block (CTCAE V4.03)
Time Frame: 12 months
CTCAE V4.03
12 months
To determine the number of patients reporting pain at 6 months
Time Frame: 6 months
Clinical examination to confirm the results of Visual analog scale, pain scores BPI and DN4
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Investigators

  • Study Director: Pierre FUMOLEAU, PHD, drci.promotion@curie.fr

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2015

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

March 9, 2019

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

April 2, 2015

First Posted (Estimate)

April 3, 2015

Study Record Updates

Last Update Posted (Actual)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 9, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC 2014-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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