Erector Spinae Block Versus Paravertebral Block on Chronic Pain After Mastectomy
The Effect of Erector Spinae Block Versus Paravertebral Block on the Incidence of Chronic Pain After Mastectomy: A Randomized Controlled Trial
The goal of this clinical trial is to learn if the erector spinae block can reduce the incidence of chronic pain compared to the paravertebral block in adult patients undergoing total mastectomy. The study includes patients aged 18 to 80 years scheduled for mastectomy, with or without axillary dissection. The main questions it aims to answer are:
- Does erector spinae block reduce the incidence of chronic pain at 3 months after mastectomy compared to paravertebral block?
- Does erector spinae block affect postoperative outcomes such as opioid consumption at 48 hours, pain scores (in PACU, 24 and 48 hours), block performance time, and the incidence of complications, anxiety or depression, and pain intensity at 3 months?
Researchers will compare patients receiving erector spinae block to those receiving paravertebral block to determine if erector spinae block provides equivalent or improved outcomes in terms of chronic pain and perioperative measures.
Participants will:
- Be randomly assigned to receive either erector spinae block or paravertebral block prior to surgery
- Undergo total mastectomy (with or without axillary dissection)
- Have their pain assessed in the PACU and at 24 and 48 hours postoperatively
- Have opioid consumption measured during the first 48 hours after surgery
- Be followed up at 3 months to assess chronic pain, pain intensity, and psychological outcomes (anxiety or depression)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background: Acute post mastectomy pain is a strong predictor of the development of chronic pain. Paravertebral block (PVB) has been shown to reduce the incidence and severity of acute and chronic pain post mastectomy. Despite the use of ultrasound, the performance of this advanced block requires special skills and training due to the proximity of the injection site to the pleura and the spinal cord. Erector spinae block (ESB), a novel regional anesthesia technique, has been shown to be equivalent to PVB in reducing the incidence and severity of acute post-surgical pain.
Specific aims: The primary objective of this study is to compare the effect of ESB and PVB on the incidence of chronic pain measured 3 months after mastectomy. Secondary objectives include assessment of cumulative opioid consumption at 48 hours post operatively, pain scores in the PACU as well as at 24 and 48 hours, time needed for performing the block, as well as complications, anxiety or depression at 3 months, pain intensity at 3 months. Methods: This prospective randomized clinical trial will be conducted in the operating rooms at AUBMC. 132 (66 in each group) adult patients scheduled to total mastectomy, with or without axillary dissection, and aging between 18 and 80 will be randomly allocated to 2 groups: The erector spinae group or the paravertebral group. Significance: It has not been demonstrated yet that the ESB is equivalent to the more conventional PVB in reducing the incidence of chronic post mastectomy pain. This study will compare the effect of ESB to PVB in reducing the incidence of chronic pain, which will improve the quality of life of patients undergoing modified radical mastectomy
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nancy Abou Nafeh, MD
- Número de teléfono: 6820 01350000
- Correo electrónico: na181@aub.edu.lb
Copia de seguridad de contactos de estudio
- Nombre: Thouraya HajAli
- Correo electrónico: th64@aub.edu.lb
Ubicaciones de estudio
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Beirut, Líbano
- Reclutamiento
- American University of Beirut Medical Center
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Contacto:
- Nancy Abou Nafeh
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adult patients between 18 and 80 years old.
- Scheduled to total mastectomy with or without axillary dissection
- Willing to receive regional anesthesia in addition to GA
- ASA classification 1-3
Exclusion Criteria:
- Previous thoracic surgery with an incision of >2 cm
- Patient's refusal
- Allergy to local anesthetics
- Pregnant women
- Any contraindications to thoracic PVB, including intrathoracic infection, infection at the puncture site, cancer invasion of the puncture site, severe spinal deformity, history of spinal surgery, and severe coagulopathy; anticoagulants intake.
- American Society of Anesthesiologists (ASA) classification of 4 or higher,
- History of chronic pain or untreated clinical severe depression
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Paravertebral block
Thoracic paravertebral block is performed at the level of T4 or T5 if no axillary procedure is to be performed, and additionally at the level of T2 if axillary procedure is planned.
A high-frequency transducer probe connected to an ultrasound (US) machine is positioned in a para-median sagittal plane, approximately 2-2.5 cm lateral to the spinous process at the ipsilateral side of surgery location to localize the transverse process and the paravertebral space.
The skin is sterilized and the US probe covered with a sterile cap.
A 22-gauge, 100 mm stimuplex nerve block needle is introduced in an in-plane direction.
After perforating the costotransverse ligament and confirming negative aspiration of blood, 20ml of a mixture of ropivacaine 0.5% is injected.
Anterior displacement of the pleura indicates appropriate spread of local anaesthesia (LA) in the paravertebral space.
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Thoracic paravertebral block is performed at the level of T4 or T5 if no axillary procedure is to be performed, and additionally at the level of T2 if axillary procedure is planned.
A high-frequency transducer probe connected to an ultrasound (US) machine is positioned in a para-median sagittal plane, approximately 2-2.5 cm lateral to the spinous process at the ipsilateral side of surgery location to localize the transverse process and the paravertebral space.
The skin is sterilized and the US probe covered with a sterile cap.
A 22-gauge, 100 mm stimuplex nerve block needle is introduced in an in-plane direction.
After perforating the costotransverse ligament and confirming negative aspiration of blood, 20ml of a mixture of ropivacaine 0.5% is injected.
Anterior displacement of the pleura indicates appropriate spread of local anaesthesia (LA) in the paravertebral space.
Otros nombres:
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Experimental: Erector Spinae block
The ESB is performed at the level of T4-T5 if no axillary procedure is to be performed, and additionally at the level of T2 (5ml) if axillary procedure is planned.
A transducer probe is positioned in a para-median sagittal plane approximately 3 cm lateral to the spinous process at the ipsilateral side of surgery.
Following the same sterilization procedure, the 10 cm stimuplex needle is introduced in an in-plane direction.
The transverse process of the vertebrae, trapezius muscle, rhomboid major and erector spinae muscle are visualized, and 25 ml of ropivacaine 0.5% mixture is injected after confirming negative aspiration of blood (lower the concentration not to exceed 2 mg/kg ideal body weight).
The LA spread lifts the erector spinae muscle off the bony shadow of the transverse process
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The ESB is performed at the level of T4-T5 if no axillary procedure is to be performed, and additionally at the level of T2 (5ml) if axillary procedure is planned.
A transducer probe is positioned in a para-median sagittal plane approximately 3 cm lateral to the spinous process at the ipsilateral side of surgery.
Following the same sterilization procedure, the 10 cm stimuplex needle is introduced in an in-plane direction.
The transverse process of the vertebrae, trapezius muscle, rhomboid major and erector spinae muscle are visualized, and 25 ml of ropivacaine 0.5% mixture is injected after confirming negative aspiration of blood (lower the concentration not to exceed 2 mg/kg ideal body weight).
The LA spread lifts the erector spinae muscle off the bony shadow of the transverse process.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Chronic pain
Periodo de tiempo: 3 months after mastectomy
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Chronic pain measured using NRS scale (0-10) 3 months after mastectomy
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3 months after mastectomy
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cumulative opioid consumption
Periodo de tiempo: Amount of opioids used by the patient 48 hours after the procedure
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Cumulative opioid consumption
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Amount of opioids used by the patient 48 hours after the procedure
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Pain score
Periodo de tiempo: Pain score measured using NRS scale (0-10) on arrival to the PACU,12 hour, 24 hour,and 48 hour after the procedure
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Pain score measured using NRS scale (0-10)
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Pain score measured using NRS scale (0-10) on arrival to the PACU,12 hour, 24 hour,and 48 hour after the procedure
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Time needed for performing the block
Periodo de tiempo: Time needed for performing the block (Perioperative)
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Time needed for performing the block in minutes
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Time needed for performing the block (Perioperative)
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Complications
Periodo de tiempo: Incidence of complications (Yes/No) (Perioperative)
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Incidence of complications (Yes/No)
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Incidence of complications (Yes/No) (Perioperative)
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Anxiety or depression
Periodo de tiempo: Anxiety or depression measured using the Hospital Anxiety and Depression Scale (HADS; range 0-42, with subscales 0-21 each), where higher scores indicate worse anxiety and depression, assessed 3 months after the procedure.
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Anxiety or depression measured using HADS
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Anxiety or depression measured using the Hospital Anxiety and Depression Scale (HADS; range 0-42, with subscales 0-21 each), where higher scores indicate worse anxiety and depression, assessed 3 months after the procedure.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nancy Abou Nafeh, MD, American University of Beirut Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BIO-2025-0326
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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