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Chronic Pain and Minor Breast Cancer Surgery (DCPO Sein)

2. marts 2020 opdateret af: Institut Claudius Regaud

Prospective Cohort Study Assessing Chronic Pain in Patients With Thoracic Blocks Following Minor Surgery for Breast Cancer.

Breast cancer is the most frequent in women. Early diagnosis and recent treatments have improved overall mortality. However, chronic pain (pain lasting more than 3 months after surgery) remains a public health problem with impact on quality of life for these patients. The incidence of pain has been reported up to 25 to 60% of patients in the literature, even many years after a radical mastectomy. The neuropathic component of the pain is usually underestimated. In a prospective cohort study we have demonstrated that 43% of patient needed on average 5mg of morphine intravenously in the recovery room after a conservative breast cancer surgery, despite a multimodal regimen of analgesic drugs. In the same study, 40% of patients reported persistent pain 3 months after the surgery. To improve the analgesia in such a population, we decided to introduce regional analgesia technique (serratus block) systematically. This became our gold standard in our daily practice. We would like to assess the efficacy of such regional analgesia techniques on opioids consumption in the recovery room and the incidence of pain 3 months after conservative breast cancer surgery.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This is a prospective observational study assessing the interest of preoperative thoracic block (injection of local anesthetic around the serratus muscle under ultrasound guidance) in the prevalence of chronic pain 3 months after a conservative breast cancer surgery.

Information on the present survey was given during pre-operative consultation and signed informed consent was obtained to enter the study.

The management of patients undergoing minor surgery for breast cancer is standardized within our department and reported in our previous study. After starting the induction of anesthesia and insertion of a laryngeal mask, a regional analgesia technique was performed under ultrasonography. Twenty ml of ropivacaine 3.75mg/ml were injected under the serratus muscle, at the lateral edge of the minor pectoralis muscle. In the absence of contraindications, multimodal analgesia consisted of paracetamol, non-steroidal anti-inflammatory drugs and nefopam. Postoperative intravenous morphine titration was possible in patients presenting a pain score >3/10 (numeric pain intensity scale from 0 = no pain to 10 = maximum imaginable pain) in the recovery room. If 0.1mg/kg of morphine did not permit to alleviate pain, ketamine titration was initiated by the anesthesiologist.

The incidence of patients that required opioids titration in the recovery room (and the dose injected) was recorded.

The questionnaire sent to the patients 3 months after their surgery was mainly composed of closed questions. This questionnaire included pain score, location of pain, analgesic drugs consumption, neuropathic component (self-administered questionnaire derived from the Neuropathic Pain 4 Questions - DN4 questionnaire), impact of quality of life using the Brief Pain Inventory.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

205

Kontakter og lokationer

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Studiesteder

  • Frankrig
    • Occitanie
      • Toulouse, Occitanie, Frankrig, 31059 cedex 09
        • Institut Claudius Regaud - IUCT-Oncopole

Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

women >18yrs old, with ASA physical status 1 to 3, with unilateral breast adenocarcinoma treated surgically by conservative tumorectomy ± associated to sentinel lymph node dissection on an ambulatory basis.

Beskrivelse

Inclusion Criteria:

  • women
  • > 18 years old
  • with "American Society of Anesthesiologists-ASA" physical status 1 to 3
  • with unilateral breast cancer adenocarcinoma treated surgically by conservative tumorectomy associated or not to sentinel lymph node dissection on an ambulatory basis

Exclusion Criteria:

  • None

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prevalence of chronic pain
Tidsramme: 3 months
To assess the number (%) of patients presenting persistent pain 3 months after minor breast cancer surgery
3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of pain
Tidsramme: 3 months
incidence of pain and mean dose of morphine injected in the recovery room, percentage of neuropathic component among patients presenting persistent pain at 3 months; impact of pain on quality of life, risk factors to develop postoperative persistent pain.
3 months

Samarbejdspartnere og efterforskere

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Sponsor

Institut Claudius Regaud

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2019

Primær færdiggørelse (Faktiske)

30. september 2019

Studieafslutning (Faktiske)

31. december 2019

Datoer for studieregistrering

Først indsendt

10. april 2019

Først indsendt, der opfyldte QC-kriterier

10. april 2019

Først opslået (Faktiske)

11. april 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. marts 2020

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CNIL-2033408

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Will not be shared

Studiedata/dokumenter

  1. Web site for patient information on studies bases on patients data (RGPD)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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