MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery

Malignant Neoplasm of Breast Clinical Trial

— MIRs03  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02408393
• Other study ID #: IC 2014-07
• Status: Completed
• Phase: Phase 3
• Start date: March 27, 2015
• Est. completion date: March 9, 2019

Study information

• Verified date: July 2019
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: March 9, 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Malignant Neoplasm of Breast
• Neoplasms

Intervention

Drug:
• Saline

• Ropivacaine

Locations

Country	Name	City	State
France	Centre Jean PERRIN	Clermont Ferrand
France	Centre Léon Bérard	Lyon
France	Centre Antoine LACASSAGNE	Nice
France	INSTITUT CURIE - Site Paris	Paris
France	Institut Curie site Saint-Cloud	Saint Cloud
France	Institut de Cancérologie de Lorraine	Vandoeuvre-les-nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

References & Publications (5)

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. Anes — View 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. — View Citation

Gärtner 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) — View Citation

Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. Review. — View Citation

Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. Review. — View Citation

Outcome

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