MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery

Sponsor

Institut Curie (Other)

Overall Status

Completed

CT.gov ID

NCT02408393

Collaborator

(none)

380

Enrollment

Locations

Arms

47.4

Actual Duration (Months)

63.3

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Neoplasm of Breast	Drug: Saline Drug: Ropivacaine	Phase 3

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

Study Type:

Interventional

Actual Enrollment :

380 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 27, 2015

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Mar 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Saline (30 mL maximum)	Drug: Saline Other Names: NA Cl 0.9%
Experimental: Ropivacaine Ropivacaine 7.5 mg/mL (0.35 mL/kg of solution)	Drug: Ropivacaine Other Names: Naropeine

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Saline (30 mL maximum)

Drug: Saline

Other Names:

NA Cl 0.9%

Experimental: Ropivacaine

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

Drug: Ropivacaine

Other Names:

Naropeine

Outcome Measures

Primary Outcome Measures

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

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 measure acute postoperative pain (Visual Analog Scale (VAS) [48 postoperative hours]
Patient satisfaction on Visual Analog Scale (VAS)
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 characterize chronic pain (Neuropathic Pain Diagnostic DN4 Questionnaire) [3 months]
Neuropathic Pain Diagnostic DN4 Questionnaire
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Jean PERRIN	Clermont Ferrand	France	63011
2	Centre Léon Bérard	Lyon	France	69008
3	Centre Antoine LACASSAGNE	Nice	France	06189 NICE Cedex
4	INSTITUT CURIE - Site Paris	Paris	France	75005
5	Institut Curie site Saint-Cloud	Saint Cloud	France	92210
6	Institut de Cancérologie de Lorraine	Vandoeuvre-les-nancy	France	54511