Clinical trial NCT02408393: MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malignant Neoplasm of Breast
Keywords: Surgery
Paravertebral block
Chronic pain
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 380
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To compare chronic pain 3 months after breast surgery in each arm
timeFrame: 3 months
Secondary outcomes:
measure: To measure the extend of dermatomes blocked
timeFrame: one year after surgery
measure: To measure acute postoperative pain (Visual Analog Scale (VAS)
timeFrame: 48 postoperative hours
measure: To determine analgesic consumption
timeFrame: 48 postoperative hours
measure: To examine incidence of nausea and vomiting
timeFrame: 48 postoperative hours
measure: To characterize chronic pain (Neuropathic Pain Diagnostic DN4 Questionnaire)
timeFrame: 3 months
measure: To evaluate the frequency of chronic pain (BPI questionnaire and Neuropathic Pain Diagnostic (DN4)
timeFrame: 6 and 12 months
measure: To compare presence of lymphedema
timeFrame: 3, 6 and 12 months
measure: To evaluate anxiety and depression evaluation (Hospital Anxiety and Depression questionnaire (HAD)
timeFrame: 3, 6 and 12 months
measure: To evaluate complications of paravertebral block (CTCAE V4.03)
timeFrame: 12 months
measure: To determine the number of patients reporting pain at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: Centre Jean PERRIN
city: Lyon
country: France
facility: Centre Léon Bérard
city: Nice
country: France
facility: Centre Antoine LACASSAGNE
city: Paris
country: France
facility: INSTITUT CURIE - Site Paris
city: Saint Cloud
country: France
facility: Institut Curie site Saint-Cloud
city: Vandoeuvre-les-nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: drci.promotion@curie.fr
name: Pierre FUMOLEAU, PHD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.