- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03912948
Chronic Pain and Minor Breast Cancer Surgery (DCPO Sein)
Prospective Cohort Study Assessing Chronic Pain in Patients With Thoracic Blocks Following Minor Surgery for Breast Cancer.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Occitanie
-
Toulouse, Occitanie, Frankrike, 31059 cedex 09
- Institut Claudius Regaud - IUCT-Oncopole
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Prevalence of chronic pain
Tidsram: 3 months
|
To assess the number (%) of patients presenting persistent pain 3 months after minor breast cancer surgery
|
3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of pain
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- 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. Erratum In: JAMA. 2012 Nov 21;308(19):1973.
- Fuzier R, Puel F, Izard P, Sommet A, Pierre S. Prospective cohort study assessing chronic pain in patients following minor surgery for breast cancer. J Anesth. 2017 Apr;31(2):246-254. doi: 10.1007/s00540-016-2288-9. Epub 2016 Nov 24.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CNIL-2033408
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Studiedata/dokument
Läkemedels- och apparatinformation, studiedokument
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