MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery

Phase 3

Completed

• Conditions: Malignant Neoplasm of Breast
• Interventions: Drug: Saline; Drug: Ropivacaine

• Registration Number: NCT02408393
• Lead Sponsor: Institut Curie

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.

Study Timeline

• Study First Submitted: 2015-03-17
• Study Start: 2015-03-27
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Primary Completion: 2018-07
• Study Completion: 2019-03-09
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 380

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	Saline (30 mL maximum)
Ropivacaine	Ropivacaine	Ropivacaine 7.5 mg/mL (0.35 mL/kg of solution)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (6)

INSTITUT CURIE - Site Paris; 🇫🇷 Paris, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Institut de Cancérologie de Lorraine; 🇫🇷 Vandoeuvre-les-nancy, France

Centre Jean PERRIN; 🇫🇷 Clermont Ferrand, France

Centre Antoine LACASSAGNE; 🇫🇷 Nice, France

Institut Curie site Saint-Cloud; 🇫🇷 Saint Cloud, France