Efficacy of Thoracic Paravertebral Block in the Reduction of Acute Post-surgical Pain in Patients With Breast Cancer
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Antioquia
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Medellín, Antioquia, Colombia
- Instituto de Cancerología IDC Las Américas
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Women older than 18 years.
- 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.
- Willingness to participate in the study during the follow-up period.
Exclusion Criteria:
- Metastatic breast carcinoma; tumor involvement of contra lateral breast or armpit determined by clinical or paraclinical studies.
- Medical History of coagulopathy.
- Consumption of anticoagulants.
- Contraindication to NSAIDs or opioids.
- Allergy to local anesthetics of amide type.
- Infection a interventions sites (paravertebral block or area affected breast surgical wound)
- Pregnancy and lactation.
- BMI>35.
- Parkinson's disease, Alzheimer's disease or other diseases that affect the mental or motor sphere.
- Double mastectomy or mastectomy history of previous ipsilateral to the current episode.
- Preoperative risk classification ASA IV-V.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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Thoracic paravertebral block at T3 level with bupivacaine 0.5%, dosis 1.5mg/Kg
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Comparador activo: 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.
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Surgical wound infiltration on the skin and subcutaneous tissue in surgical area with bipivacaine 0.5%, dosis 1.5mg/kg
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acute post-surgical pain at rest and motion
Periodo de tiempo: 24 hours
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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.
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24 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adverse Events
Periodo de tiempo: 2 months
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Compare the frequency and severity of adverse events in both groups
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2 months
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Total doses of opioids
Periodo de tiempo: 24 hours
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Compare the total dose of self-administered opioids analgesics for the first 24 hours
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24 hours
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Time to the first dose of opioids
Periodo de tiempo: 24 hours
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Compare the time to first dose of opioids analgesics in both groups
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24 hours
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Post-mastectomy pain syndrome
Periodo de tiempo: 2 months
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Compare the frequency of diagnosis of Post-mastectomy pain syndrome (SDP) two months after breast surgery in both groups
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2 months
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Quality of life
Periodo de tiempo: 2 months
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Estimate the changes in the quality of life of patients after two months after breast surgery in both groups
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2 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Fernando Herazo, MD, MSc, Instituto de Cancerología IDC Las Américas
- Investigador principal: Hector I García, MD, MPH, MSc, Instituto de Cancerología IDC Las Américas
- Investigador principal: Jorge A Egurrola, MD, Instituto de Cancerología IDC Las Américas
Publicaciones y enlaces útiles
Publicaciones Generales
- Kairaluoma PM, Bachmann MS, Korpinen AK, Rosenberg PH, Pere PJ. Single-injection paravertebral block before general anesthesia enhances analgesia after breast cancer surgery with and without associated lymph node biopsy. Anesth Analg. 2004 Dec;99(6):1837-1843. doi: 10.1213/01.ANE.0000136775.15566.87.
- Sidiropoulou T, Buonomo O, Fabbi E, Silvi MB, Kostopanagiotou G, Sabato AF, Dauri M. A prospective comparison of continuous wound infiltration with ropivacaine versus single-injection paravertebral block after modified radical mastectomy. Anesth Analg. 2008 Mar;106(3):997-1001, table of contents. doi: 10.1213/ane.0b013e31816152da.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IDC0001
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