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

Primary Purpose

Malignant Neoplasm of Breast

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Saline
Ropivacaine
Sponsored by
Institut Curie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Neoplasm of Breast focused on measuring Surgery, Paravertebral block, Chronic pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Jean PERRIN
  • Centre Léon Bérard
  • Centre Antoine LACASSAGNE
  • INSTITUT CURIE - Site Paris
  • Institut Curie site Saint-Cloud
  • Institut de Cancérologie de Lorraine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Ropivacaine

Arm Description

Saline (30 mL maximum)

Ropivacaine 7.5 mg/mL (0.35 mL/kg of solution)

Outcomes

Primary Outcome Measures

To compare chronic pain 3 months after breast surgery in each arm
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)

Secondary Outcome Measures

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

Full Information

First Posted
March 17, 2015
Last Updated
July 9, 2019
Sponsor
Institut Curie
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1. Study Identification

Unique Protocol Identification Number
NCT02408393
Brief Title
MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery
Acronym
MIRs03
Official Title
MIRs03: A Double-blind Randomized Trial of Paravertebral Block With Ropivacaine Before Breast Cancer Surgery: Effects on Chronic Postoperative Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 27, 2015 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
March 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Neoplasm of Breast
Keywords
Surgery, Paravertebral block, Chronic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
380 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline (30 mL maximum)
Arm Title
Ropivacaine
Arm Type
Experimental
Arm Description
Ropivacaine 7.5 mg/mL (0.35 mL/kg of solution)
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
NA Cl 0.9%
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropeine
Primary Outcome Measure Information:
Title
To compare chronic pain 3 months after breast surgery in each arm
Description
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)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
To measure the extend of dermatomes blocked
Description
The extent of dermatomes blocked as measured by clinical examination to determine area where temperature perception change
Time Frame
one year after surgery
Title
To measure acute postoperative pain (Visual Analog Scale (VAS)
Description
Patient satisfaction on Visual Analog Scale (VAS)
Time Frame
48 postoperative hours
Title
To determine analgesic consumption
Description
consumption during the first 48 postoperative hours: morphine paracetamol and ketoprofen
Time Frame
48 postoperative hours
Title
To examine incidence of nausea and vomiting
Description
Common Toxicity Criteria for Adverse Effects (CTCAE) V4.03
Time Frame
48 postoperative hours
Title
To characterize chronic pain (Neuropathic Pain Diagnostic DN4 Questionnaire)
Description
Neuropathic Pain Diagnostic DN4 Questionnaire
Time Frame
3 months
Title
To evaluate the frequency of chronic pain (BPI questionnaire and Neuropathic Pain Diagnostic (DN4)
Description
BPI questionnaire and Neuropathic Pain Diagnostic (DN4)
Time Frame
6 and 12 months
Title
To compare presence of lymphedema
Description
Clinical examination
Time Frame
3, 6 and 12 months
Title
To evaluate anxiety and depression evaluation (Hospital Anxiety and Depression questionnaire (HAD)
Description
Hospital Anxiety and Depression questionnaire (HAD)
Time Frame
3, 6 and 12 months
Title
To evaluate complications of paravertebral block (CTCAE V4.03)
Description
CTCAE V4.03
Time Frame
12 months
Title
To determine the number of patients reporting pain at 6 months
Description
Clinical examination to confirm the results of Visual analog scale, pain scores BPI and DN4
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 18 years ≤ Age ≥ 85 years. ASA class 1, 2 or 3. No analgesic treatment for 2 days (no pre-existing chronic pain) 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) Life expectancy ≥ 2 years. Signed informed consent form. Patient able to meet the self-assessments questionnaires (sufficient understanding assessments, proficiency in French) 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: 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. Bilateral breast carcinoma at the inclusion Male subjects. Metastatic breast carcinoma at diagnosis (M1). Severe heart, liver and respiratory failure (ASA 4) Allergy to local anesthetics and morphine. Use of analgesics during the 48 hours preceding the surgical procedure. History of breast surgery with painful sequelae Major deformation of the spine Puncture site infection History of substance abuse. Pregnant or lactating women, or women of childbearing potential without effective contraception Subjects deprived of their liberty or under guardianship (including temporary guardianship). Subjects unable to comply with medical follow-up of the trial for geographical, social or psychological reasons.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre FUMOLEAU, PHD
Organizational Affiliation
drci.promotion@curie.fr
Official's Role
Study Director
Facility Information:
Facility Name
Centre Jean PERRIN
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Centre Antoine LACASSAGNE
City
Nice
ZIP/Postal Code
06189 NICE Cedex
Country
France
Facility Name
INSTITUT CURIE - Site Paris
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Institut Curie site Saint-Cloud
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Institut de Cancérologie de Lorraine
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23340346
Citation
Cohen SP, Raja SN. Prevention of chronic postsurgical pain: the ongoing search for the holy grail of anesthesiology. Anesthesiology. 2013 Feb;118(2):241-3. doi: 10.1097/ALN.0b013e31827d4129. No abstract available.
Results Reference
result
PubMed Identifier
23340351
Citation
Albi-Feldzer A, Mouret-Fourme E E, Hamouda S, Motamed C, Dubois PY, Jouanneau L, Jayr C. A double-blind randomized trial of wound and intercostal space infiltration with ropivacaine during breast cancer surgery: effects on chronic postoperative pain. Anesthesiology. 2013 Feb;118(2):318-26. doi: 10.1097/ALN.0b013e31827d88d8.
Results Reference
result
PubMed Identifier
19903919
Citation
Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. Erratum In: JAMA. 2012 Nov 21;308(19):1973.
Results Reference
result
PubMed Identifier
16698416
Citation
Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
Results Reference
result
PubMed Identifier
11020770
Citation
Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.
Results Reference
result

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MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery

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