Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Video-assisted Thoracoscopic Pneumonectomy (r-PVB-1)
5 de mayo de 2026 actualizado por: Xiangcai Ruan, MD, PhD, Sixth Affiliated Hospital, Sun Yat-sen University
Revised-Paravertebral Nerve Blocks for Video-Assisted Thoracoscopic Surgery: A Randomized, Controlled, Observer-masked Noninferiority Trial.
Revised-Paravertebral Nerve Block (r-PVB) is performed right after induction of general anesthesia and before lateral positioning of surgery.
Under ultrasound guidance, an intercostal space between the 6th and 8th ribs at the midaxillary line is identified.
Using an in-plane technique, the needle is advanced into the internal intercostal muscle, and 30 mL of 0.5% ropivacaine is injected to achieve the block.
Traditional Paravertebral Nerve Block (PVB) is performed right after the lateral positioning of surgery under ultrasound guidance.
According to the operator's preference, choose any of the commonly used three traditional paravertebral block approaches.
Among these 3 approaches, the axial plane approach is recommended as the first choice: use the convex probe to identify the 6th and 8th transverse processes, then scan cranially to display the superior costotransverse ligament, pleura, and paravertebral space.
Under sterile conditions, insert the needle in-plane approximately 2 cm lateral to the probe, ensuring the ultrasound probe remains stable and dynamically visualizing the needle advancement.
Stop advancing the needle when the tip passes through the superior costotransverse ligament.
Administer 2% lidocaine in pulsatile injections, 1-2 ml per pulse, observing the spread of fluid at the needle tip on ultrasound and depression of the pleura.
Repeat pulsatile injections until a total of 5 ml lidocaine is administered, and if necessary, increase with another 5 ml of pulsatile lidocaine.
The fluid movement and pleura depression observed on ultrasound confirm proper needle placement.
Then, use this needle to inject 30 ml of 0.5% ropivacaine to complete the PVB.
The surgical procedure will start right after the intervention blocks.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
200
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Xiangcai Ruan, MD
- Número de teléfono: +86 13760710099
- Correo electrónico: ruanxc@mail.sysu.edu.cn
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Age 18 years or older
- Scheduled for elective video-assisted thoracoscopic pneumonectomy for benign or malignant diseases
Exclusion Criteria:
- Contraindications to nerve block, including skin infection at the puncture site, increased intracranial pressure, uncorrectable coagulopathy, bridging indication for therapeutic anticoagulation (CHADS-VASc ≥ 8), sepsis, or allergy to local anesthetics
- Surgeon-estimated high likelihood of conversion to open surgery
- Chronic opioid use
- Heart failure, liver failure, or renal failure
- Coagulation disorders
- History of allergy to local anesthetics
- Inability to comply with the study protocol, including severe psychiatric illness, refusal to provide informed consent, or anticipated difficulty with postoperative follow-up
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
|
Experimental: r-PVB
Participants in this arm will receive Revised-Paravertebral Nerve Block (r-PVB) after induction of general anesthesia and before the start of surgery.
|
Revised-Paravertebral Nerve Block (r-PVB) is performed after induction of general anesthesia and before the start of surgery.
Under ultrasound guidance, an intercostal space between the 7th and 9th ribs at the midaxillary line is identified.
Using an in-plane technique, the needle is advanced into the internal intercostal muscle, and 30 mL of 0.5% ropivacaine is injected to achieve the block.
|
|
Otro: PVB
Control
|
Paravertebral Nerve Block (PVB), the control of investigated intervention, is performed right after the lateral positioning of surgery under ultrasound guidance.
According to the operator's preference, choose any of the commonly used three traditional paravertebral block approaches.
Among these 3 approaches, the axial plane approach is recommended as the first choice: use the convex probe to identify the transverse process, then scan cranially to display the superior costotransverse ligament, pleura, and paravertebral space.
Under sterile conditions, insert the needle in-plane approximately 2 cm lateral to the probe, ensuring the ultrasound probe remains stable and dynamically visualizing the needle advancement.
Stop advancing the needle when the tip passes through the superior costotransverse ligament.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean postoperative NRS pain score during the first 2 postoperative days
Periodo de tiempo: From post-anesthesia care unit through postoperative day 2
|
Postoperative pain will be assessed using a Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine).
The primary pain outcome is the mean of 8 postoperative NRS pain scores collected in the post-anesthesia care unit, on the evening of surgery, and on postoperative days 1 and 2 (morning, midday, and evening).
|
From post-anesthesia care unit through postoperative day 2
|
|
Mean QoR-15 score on postoperative days 1 and 2
Periodo de tiempo: Postoperative day 1 and postoperative day 2
|
Quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15), ranging from 0 (the worst) to 150 (the best).
The primary recovery outcome is the mean QoR-15 score measured on postoperative day 1 and postoperative day 2.
|
Postoperative day 1 and postoperative day 2
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postoperative opioid and analgesic consumption
Periodo de tiempo: Postoperative day 1 and postoperative day 2
|
Postoperative opioid and other analgesic consumption will be recorded and compared between groups.
Opioid use will be converted to oral morphine equivalents where appropriate.
|
Postoperative day 1 and postoperative day 2
|
|
Postoperative complications
Periodo de tiempo: From surgery through postoperative day 30
|
Postoperative complications, including pneumothorax, nausea, vomiting, dizziness, respiratory depression, and other adverse events, will be recorded and compared between groups.
|
From surgery through postoperative day 30
|
|
Length of postoperative hospital stay
Periodo de tiempo: From surgery through postoperative day 30
|
Length of hospital stay will be defined as the total number of days hospitalized after surgery, including readmission within 30 days if applicable.
|
From surgery through postoperative day 30
|
|
Patient satisfaction with analgesia
Periodo de tiempo: Postoperative day 2
|
Patient satisfaction with postoperative analgesia will be assessed using a 5-point scale ranging from very dissatisfied to very satisfied.
|
Postoperative day 2
|
|
Resting and movement NRS pain scores on postoperative days 1 and 2
Periodo de tiempo: Postoperative day 1 and postoperative day 2
|
Resting and movement-related pain will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine), at predefined time points on postoperative days 1 and 2.
|
Postoperative day 1 and postoperative day 2
|
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Proportion of participants with pain score 4 or greater
Periodo de tiempo: Postoperative day 1 and postoperative day 2
|
The proportion of participants with clinically significant pain, defined as the Numerical Rating Scale (NRS, 0-10) of 4 or greater, will be compared between groups.
|
Postoperative day 1 and postoperative day 2
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of local anesthetic systemic toxicity
Periodo de tiempo: From intervention through postoperative day 30
|
The incidence of local anesthetic systemic toxicity (LAST) will be recorded and compared between groups.
|
From intervention through postoperative day 30
|
|
Morbidity within 30 days after surgery
Periodo de tiempo: From surgery through postoperative day 30
|
Postoperative morbidity within 30 days after surgery will be recorded and compared between groups.
|
From surgery through postoperative day 30
|
|
Readmission within 30 days after surgery
Periodo de tiempo: From surgery through postoperative day 30
|
Hospital readmission within 30 days after surgery will be recorded and compared between groups.
|
From surgery through postoperative day 30
|
|
Pain scores at 30 days after surgery
Periodo de tiempo: Postoperative day 30
|
Resting and movement-related pain at 30 days after surgery will be assessed using the Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain the patient can imagine).
|
Postoperative day 30
|
|
QoR-15 score at 30 days after surgery
Periodo de tiempo: Postoperative day 30
|
Quality of recovery at 30 days after surgery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15), ranging from 0 (the worst) to 150 (the best).
|
Postoperative day 30
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
6 de mayo de 2026
Finalización primaria (Estimado)
30 de abril de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
28 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de abril de 2026
Publicado por primera vez (Actual)
5 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
5 de mayo de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- E2026081
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .