- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07571902
Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure (r-PVB III)
6 de mayo de 2026 actualizado por: Xiangcai Ruan, MD, PhD, Sixth Affiliated Hospital, Sun Yat-sen University
Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Stoma Closure: A Randomized Clinical Trial
After stoma closure, pain remains an important problem affecting patient recovery.
A revised paravertebral block (r-PVB) was developed as a single-shot, large-volume intercostal-space injection performed at the exposed mid-axillary ninth to eleventh intercostal level with the patient kept supine after induction of anesthesia.
Rather than puncturing the classical paraspinal target near the transverse process with the patient in a prone or lateral position, the r-PVB technique is designed to exploit retrograde spread of local anesthetic from the intercostal space to the paravertebral space, thereby generating a functional paravertebral block while avoiding direct entry into the paravertebral space and the need for specific body positioning.
The r-PVB technique addresses several practical limitations of conventional PVB by eliminating the need to reposition an anesthetized patient, using a more accessible and potentially clearer sonographic window, reducing interference from transverse-process shadowing, and facilitating in-plane needle visualization.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
250
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
No
Descripción
Inclusion Criteria:
- Adults aged 18 years or older.
- Patients scheduled to undergo elective ileostomy, colostomy, or ileocolostomy reversal surgery.
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.
- Expected operative time longer than 150 minutes, or stoma reversal not being the primary surgical procedure.
- Chronic opioid use.
- Heart failure, liver failure, renal failure, coagulation disorders, or a history of allergy to local anesthetics.
- Inability to comply with study procedures, including severe psychiatric illness, refusal to sign informed consent, or anticipated difficulty in completing 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 |
|---|---|
|
Sin intervención: Control
|
|
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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.
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Participants assigned to the intervention group will receive an ultrasound-guided revised paravertebral block (r-PVB) after induction of general anesthesia and before surgical incision.
With the patient in the supine position and the ipsilateral arm abducted, a high-frequency linear ultrasound probe is placed at the mid-axillary line to identify the ninth to eleventh intercostal space on the operative side, together with the pleura and intercostal muscle layers.
Using an in-plane technique, the block needle is advanced under real-time ultrasound guidance into the plane of the internal intercostal muscle.
Correct needle tip placement is confirmed by small test injections producing characteristic pleural displacement on ultrasound.
After confirmation, 30 mL of 0.5% ropivacaine is injected into the target plane to achieve a functional paravertebral block.
Routine surgery then proceeds.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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.
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Postoperative day 1 and postoperative day 2
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Mean postoperative NRS pain score during the first 2 postoperative days
Periodo de tiempo: From discharge from the post-anesthesia care unit through postoperative day 2.
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Postoperative pain will be assessed using theNumeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine).The primary pain outcome is the mean of eight postoperative NRS pain scores assessed upon discharge from the post-anesthesia care unit; on the evening of surgery between 7:00 PM and 9:00 PM; and on postoperative days 1 and 2, in the morning between 6:00 AM and 10:00 AM, at midday between 12:00 PM and 3:00 PM, and in the evening between 7:00 PM and 9:00 PM.
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From discharge from the post-anesthesia care unit through 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.
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Postoperative day 1 and postoperative day 2
|
|
Postoperative complications
Periodo de tiempo: From surgery through postoperative day 30
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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.
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From surgery through postoperative day 30
|
|
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 ScaletheNumeric 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.
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Postoperative day 1 and postoperative day 2
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Proportion of participants with NRS pain score 4 or greater
Periodo de tiempo: Postoperative day 1 and postoperative day 2
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The proportion of participants with clinically significant pain, defined as an Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine), score of 4 or greater, will be compared between groups.
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Postoperative day 1 and postoperative day 2
|
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Patient satisfaction with analgesia
Periodo de tiempo: Postoperative day 2
|
Patient satisfaction with postoperative analgesia will be assessed using a a Numeric Rating Scale, ranging from 0 (very dissatisfied) to 10 (very satisfied).
|
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.
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From intervention through postoperative day 30
|
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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
|
|
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).
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Postoperative day 30
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NRS pain scores at 30 days after surgery
Periodo de tiempo: Postoperative day 30
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Resting and movement-related pain at 30 days after surgery will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine).
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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)
27 de abril de 2026
Finalización primaria (Estimado)
27 de marzo de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
27 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2026
Publicado por primera vez (Actual)
6 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
6 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
- E2026079
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
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