NCT02408393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2015

Typical duration for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

March 27, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2019

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

3.3 years

First QC Date

March 17, 2015

Last Update Submit

July 9, 2019

Conditions

Malignant Neoplasm of Breast

Keywords

SurgeryParavertebral blockChronic pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • To measure the extend of dermatomes blocked

    one year after surgery

  • To measure acute postoperative pain (Visual Analog Scale (VAS)

    48 postoperative hours

  • To determine analgesic consumption

    48 postoperative hours

  • To examine incidence of nausea and vomiting

    48 postoperative hours

  • To characterize chronic pain (Neuropathic Pain Diagnostic DN4 Questionnaire)

    3 months

  • +5 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Saline (30 mL maximum)

Drug: Saline

Ropivacaine

EXPERIMENTAL

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

Drug: Ropivacaine

Interventions

SalineDRUG
Also known as: NA Cl 0.9%
Placebo
RopivacaineDRUG
Also known as: Naropeine
Ropivacaine

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centre Jean PERRIN

Clermont-Ferrand, 63011, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Centre Antoine LACASSAGNE

Nice, 06189 NICE Cedex, France

Location

INSTITUT CURIE - Site Paris

Paris, 75005, France

Location

Institut Curie site Saint-Cloud

Saint-Cloud, 92210, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (5)

  • 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.

    PMID: 23340346RESULT

  • 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.

    PMID: 23340351RESULT

  • 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.

    PMID: 19903919RESULT

  • 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.

    PMID: 16698416RESULT

  • 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.

    PMID: 11020770RESULT

MeSH Terms

Conditions

Breast NeoplasmsChronic Pain

Interventions

Sodium ChlorideRopivacaine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Pierre FUMOLEAU, PHD

    drci.promotion@curie.fr

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2015

First Posted

April 3, 2015

Study Start

March 27, 2015

Primary Completion

July 1, 2018

Study Completion

March 9, 2019

Last Updated

July 10, 2019

Record last verified: 2019-07

Locations

FR(6)