Malignant Neoplasm of BreastPhase 3MIRs03NCT02408393
MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery
A Phase 3 study testing Saline and Ropivacaine in people with Malignant Neoplasm of Breast, run by Institut Curie at 6 sites in France.
Trial summary
Compare the effect of paravertebral block (PVB) with Ropivacaine or placebo on the incidence of chronic pain 3 months after breast cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Malignant Neoplasm of Breast
- What is being tested?
- Saline and Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 6 sitesFrance
- Study dates
- 27 Mar 2015to 9 Mar 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre Jean PERRIN
Clermont-Ferrand, 63011
Centre Léon Bérard
Lyon, 69008
Centre Antoine LACASSAGNE
Nice, 06189 NICE Cedex
INSTITUT CURIE - Site Paris
Paris, 75005
Institut Curie site Saint-Cloud
Saint-Cloud, 92210
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54511
About this study
Official title: 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.
Read the 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.
- Conditions
- Malignant Neoplasm of Breast
- Being tested
- Saline, Ropivacaine
- Keywords
- Surgery, Paravertebral block, Chronic pain
- Medical subject headings
- Breast Neoplasms, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Also called NA Cl 0.9%
RopivacaineDrug
Also called Naropeine
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline (30 mL maximum) Receives: Drug: Saline |
| Ropivacaine | Experimental | Ropivacaine 7.5 mg/mL (0.35 mL/kg of solution) Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (10)
To measure the extend of dermatomes blocked
The extent of dermatomes blocked as measured by clinical examination to determine area where temperature perception change
Measured: one year after surgery
To measure acute postoperative pain (Visual Analog Scale (VAS)
Patient satisfaction on Visual Analog Scale (VAS)
Measured: 48 postoperative hours
To determine analgesic consumption
consumption during the first 48 postoperative hours: morphine paracetamol and ketoprofen
Measured: 48 postoperative hours
To examine incidence of nausea and vomiting
Common Toxicity Criteria for Adverse Effects (CTCAE) V4.03
Measured: 48 postoperative hours
To characterize chronic pain (Neuropathic Pain Diagnostic DN4 Questionnaire)
Neuropathic Pain Diagnostic DN4 Questionnaire
Measured: 3 months
To evaluate the frequency of chronic pain (BPI questionnaire and Neuropathic Pain Diagnostic (DN4)
BPI questionnaire and Neuropathic Pain Diagnostic (DN4)
Measured: 6 and 12 months
To compare presence of lymphedema
Clinical examination
Measured: 3, 6 and 12 months
To evaluate anxiety and depression evaluation (Hospital Anxiety and Depression questionnaire (HAD)
Hospital Anxiety and Depression questionnaire (HAD)
Measured: 3, 6 and 12 months
To evaluate complications of paravertebral block (CTCAE V4.03)
CTCAE V4.03
Measured: 12 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study start27 Mar 2015
- Primary completionJul 2018
- Study completion9 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Malignant Neoplasm of BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre FUMOLEAU, PHD, Study director, drci.promotion@curie.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408393
- Sponsor's protocol ID
- IC 2014-07
- Acronym
- MIRs03
- Status last verified
- Jul 2019
- First submitted
- 17 Mar 2015
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23340346Albi-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.
PubMed 23340351Gartner 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.
PubMed 19903919Kehlet 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.
PubMed 16698416Perkins 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.
PubMed 11020770
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIRs03: A Double-blind Randomized Trial of Paravertebral Block With Ropivacaine Before Breast Cancer Surgery: Effects on Chronic Postoperative Pain
- ClinicalTrials.gov ID
- NCT02408393
- Acronym / sponsor ID
- MIRs03 / IC 2014-07
- Conditions
- Malignant Neoplasm of Breast
- Keywords
- Surgery, Paravertebral block, Chronic pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 27 Mar 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- 9 Mar 2019 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: SalineSaline (30 mL maximum) |
| Ropivacaine | Experimental | Drug: RopivacaineRopivacaine 7.5 mg/mL (0.35 mL/kg of solution) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Women with non-metastatic invasive breast carcinoma or breast carcinoma in situ treated by:
- 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)
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalineAlso: NA Cl 0.9% | Drug | Placebo |
| RopivacaineAlso: Naropeine | Drug | Ropivacaine |
Primary outcome
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)
10 secondary outcomes
To measure the extend of dermatomes blocked
Time frame: one year after surgery
To measure acute postoperative pain (Visual Analog Scale (VAS)
Time frame: 48 postoperative hours
To determine analgesic consumption
Time frame: 48 postoperative hours
To examine incidence of nausea and vomiting
Time frame: 48 postoperative hours
To characterize chronic pain (Neuropathic Pain Diagnostic DN4 Questionnaire)
Time frame: 3 months
To evaluate the frequency of chronic pain (BPI questionnaire and Neuropathic Pain Diagnostic (DN4)
Time frame: 6 and 12 months
To compare presence of lymphedema
Time frame: 3, 6 and 12 months
To evaluate anxiety and depression evaluation (Hospital Anxiety and Depression questionnaire (HAD)
Time frame: 3, 6 and 12 months
To evaluate complications of paravertebral block (CTCAE V4.03)
Time frame: 12 months
To determine the number of patients reporting pain at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Results publication: PubMed 23340346Cohen 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 publication: PubMed 23340351Albi-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 publication: PubMed 19903919Gartner 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.
- Results publication: PubMed 16698416Kehlet 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 publication: PubMed 11020770Perkins 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre FUMOLEAU, PHD study director
drci.promotion@curie.fr
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Saline and Ropivacaine in people with Malignant Neoplasm of Breast, run by Institut Curie at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare chronic pain 3 months after breast surgery in each arm (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02408393, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.