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Efficacy of Thoracic Paravertebral Block in the Reduction of Acute Post-surgical Pain in Patients With Breast Cancer

23. december 2016 opdateret af: Instituto de Cancerología S.A.

Efficacy of Thoracic Paravertebral Block vs Local Anesthesia of the Surgical Wound in Reduction of Acute Post-surgical Pain in Patients With Breast Cancer. Controlled Phase III, Randomized, Single-blind, Superiority Clinical Trial.

Surgical treatment of breast cancer is frequently associated with postoperative pain in the surgical area. Persistent pain after breast cancer management has considerable negative effects on the quality of life of survivors. The aim of this trials is to evaluate the efficacy of thoracic paravertebral block with bupivacine 0.5% in reducing the acute pain postmastectomy compare with surgical wound infiltration with bupivacaine 0.5%.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Surgical treatment of breast cancer is frequently associated with postoperative pain in the surgical area, restricted movement of the ipsilateral upper limb and increased risk of chronic pain. This usually occurs even though management with analgesics commonly used in the postoperative period. Properly treatment of acute postoperative pain have essential implications: improving the general welfare of patients, can better withstand future medical interventions, facilitating recovery in the short and long term and is believed to have positive impact on survival from cancer.

Persistent pain after breast cancer management has considerable negative effects on the quality of life of survivors. Several risks factors have been described in preoperative, intra-operative and postoperative periods of persistent or chronic pain. In the postoperative period the most important risk factor is the severity of acute pain. For this, pain relief is an essential component of care of patients undergoing breast cancer surgery. Current evidence suggests that treatment of acute postoperative pain reduces the risk of persistent or chronic pain syndrome. The surgical wound infiltration with local anesthesia has been used routinely in patients managed at the Cancer Institute and Clinica Las Americas and is described as a safe and accessible procedure for the management of acute postoperative pain. Paravertebral block represents an interesting alternative in the management of perioperative pain, often used for breast surgery, hernia repair and thoracotomy in children and adults. Although complications associated with blocking are uncommon, the implementation of Ultrasound-guided approach has become the standard for performing said method.

Such considerations have led us to evaluate whether patients with breast cancer who are undergoing mastectomy, thoracic paravertebral block could be better in relief acute pain in comparison with surgical wound infiltration with local anesthesia. This will be studied by controlled randomized to one of two intervention groups (paravertebral block or local anesthesia with infiltration of the surgical wound) allocation trial. In all patients, general anesthesia and routine postoperative analgesic is used.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia
        • Instituto de Cancerología IDC Las Américas

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  1. Women older than 18 years.
  2. Diagnosis of breast cancer requiring major elective surgery: unilateral mastectomy with or without axillary dissection; with or without axillary sentinel node biopsy; with or without immediate breast reconstruction.
  3. Willingness to participate in the study during the follow-up period.

Exclusion Criteria:

  1. Metastatic breast carcinoma; tumor involvement of contra lateral breast or armpit determined by clinical or paraclinical studies.
  2. Medical History of coagulopathy.
  3. Consumption of anticoagulants.
  4. Contraindication to NSAIDs or opioids.
  5. Allergy to local anesthetics of amide type.
  6. Infection a interventions sites (paravertebral block or area affected breast surgical wound)
  7. Pregnancy and lactation.
  8. BMI>35.
  9. Parkinson's disease, Alzheimer's disease or other diseases that affect the mental or motor sphere.
  10. Double mastectomy or mastectomy history of previous ipsilateral to the current episode.
  11. Preoperative risk classification ASA IV-V.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Thoracic Paravertebral Block
to identify the thoracic T3, a parallel line 2.5 cm from the spinous process is drawn and in this place the ultrasound sensor is placed. Ultrasonograph image identifies the transverse process, the intercostal cost-transverse ligament, the pleura and lung. We proceed to insert a needle between the two corresponding transverse processes and positions after passing the cost-ligament posterior intercostal and transverse to the parietal pleura. After negative aspiration for blood, 0.5% bupivacaine anesthetic is administered at doses of 1.5 mg/kg slowly. The volume is defined by the anesthesiologist. The injection of anesthetic is displayed, as well as confirmation of the correct location of the needle because the volume injected above pushes the pleura.
Procedure: Thoracic Paravertebral Block
Thoracic paravertebral block at T3 level with bupivacaine 0.5%, dosis 1.5mg/Kg
Aktiv komparator: Surgical Wound Infiltration
before the close of the skin, it proceeds to infiltrate the subcutaneous tissue and skin with 0.5% bupivacaine at doses of 1.5 mg/kg, generating the widest possible dissemination of the bupivacaine in the surgical area.
Procedure: Surgical Wound Infiltration
Surgical wound infiltration on the skin and subcutaneous tissue in surgical area with bipivacaine 0.5%, dosis 1.5mg/kg

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acute post-surgical pain at rest and motion
Tidsramme: 24 hours
Acute pain at rest and in motion at 2, 4, 6, 12 and 24 hours post operative, measured by a visual analog scale (0-100 mm) for the paravertebral block group compared with the surgical wound infiltration group.
24 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse Events
Tidsramme: 2 months
Compare the frequency and severity of adverse events in both groups
2 months
Total doses of opioids
Tidsramme: 24 hours
Compare the total dose of self-administered opioids analgesics for the first 24 hours
24 hours
Time to the first dose of opioids
Tidsramme: 24 hours
Compare the time to first dose of opioids analgesics in both groups
24 hours
Post-mastectomy pain syndrome
Tidsramme: 2 months
Compare the frequency of diagnosis of Post-mastectomy pain syndrome (SDP) two months after breast surgery in both groups
2 months
Quality of life
Tidsramme: 2 months
Estimate the changes in the quality of life of patients after two months after breast surgery in both groups
2 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Instituto de Cancerología S.A.

Efterforskere

  • Ledende efterforsker: Fernando Herazo, MD, MSc, Instituto de Cancerología IDC Las Américas
  • Ledende efterforsker: Hector I García, MD, MPH, MSc, Instituto de Cancerología IDC Las Américas
  • Ledende efterforsker: Jorge A Egurrola, MD, Instituto de Cancerología IDC Las Américas

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

1. november 2015

Primær færdiggørelse (Faktiske)

1. august 2016

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

14. september 2015

Først indsendt, der opfyldte QC-kriterier

17. november 2015

Først opslået (Skøn)

20. november 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. december 2016

Sidst verificeret

1. december 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IDC0001

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