A Clinical Study on Vagus Nerve Blockade at the Gastroesophageal Junction Combined With Tegileridine in the Very Early Postoperative Recovery Following Bariatric Surgery
This study aims to investigate, through a prospective randomized controlled clinical trial, the clinical value of vagal nerve block at the gastroesophageal junction combined with tizanidine in the very early postoperative recovery following bariatric surgery. Patients who have undergone bariatric surgery often experience visceral pain due to the inflammatory response triggered by partial gastrectomy. Conventional analgesic regimens have limited efficacy in controlling this type of visceral pain, whereas vagus nerve block at the gastroesophageal junction can directly block the transmission of pain signals from this region, thereby specifically alleviating visceral pain; the combined use of tegileridine could reduce postoperative opioid dosage and lower the risk of related adverse reactions. By comparing these two different analgesic regimens, this study examines their effects on patients' postoperative pain intensity, early mobilization, and adverse reactions such as respiratory depression, nausea, vomiting, and constipation. This study aims to clarify the efficacy and safety of this combined regimen in precisely relieving visceral pain, optimizing perioperative analgesia, reducing opioid-related complications, alleviating gastrointestinal adverse reactions, promoting early ambulation, and accelerating recovery, thereby providing clinical evidence for the establishment of a more comprehensive and individualized multimodal analgesia and Enhanced Recovery After Surgery (ERAS) system for bariatric surgery.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Aged 18 to 70 years, regardless of gender;
- BMI meets the clinical criteria for bariatric surgery;
- ASA physical status classification I-II;
- Scheduled to undergo laparoscopic sleeve gastrectomy or gastric bypass surgery;
- Fully understands the details of this study, voluntarily agrees to participate, and has signed a written informed consent form
Exclusion Criteria:
- Contraindications for regional nerve block procedures (e.g., coagulation disorders, infection at the puncture site, etc.);
- Allergy to local anesthetics, tizanidine, or opioids;
- Severe cardiac, pulmonary, hepatic, or renal dysfunction;
- History of chronic pain or long-term use of opioid analgesics prior to surgery;
- Pregnant or breastfeeding women;
- Mental illness or cognitive impairment that prevents the participant from cooperating with pain scoring and other assessments;
- Other circumstances deemed by the investigator to make the participant unsuitable for participation in this study;
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Comparador activo: The control group
Bilateral transverse abdominal plane block and intravenous administration of Tegileridine |
Bilateral Transversus Abdominis Plane Block (TAPB): Ultrasound-guided TAPB, 20 mL of 0.25% ropivacaine on each side. Intravenous infusion of 1 mg of Tegileridine. |
|
Experimental: The experimental group
Bilateral transverse abdominal plane block and intravenous administration of Tegileridine combined with the vagus nerve block at the gastroesophageal junction |
Bilateral Transversus Abdominis Plane Block (TAPB): Ultrasound-guided TAPB, 20 mL of 0.25% ropivacaine on each side. Intravenous infusion of 1 mg of Tegileridine. Vagus nerve block at the gastroesophageal junction: Under direct laparoscopic visualization, locate the vagus nerve trunks on both sides of the gastroesophageal junction and inject 3 mL of 0.33% ropivacaine into each side. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Visual analogue scale (VAS) Score
Periodo de tiempo: postoperative 0, 2, 6, 12, and 24 hours
|
The VAS score refers to drawing a 10-cm scale on a piece of paper. One end of the scale is marked as 0, indicating no pain; the other end is marked as 10, indicating severe pain; the values in between represent different degrees of pain. |
postoperative 0, 2, 6, 12, and 24 hours
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality-of-Recovery 15 (QoR-15) Score
Periodo de tiempo: postoperative 1 day
|
The QoR-15 includes 5 items related to physical comfort, 4 items regarding emotional state, 2 items concerning self-care ability, 2 items related to psychological support, and 2 items about pain. There are a total of 15 subjective parameters. Each item is scored on a scale of 0 to 10. The total score of QoR-15 ranges from 0 to 150. The higher the score, the better the condition. |
postoperative 1 day
|
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Incidence of postoperative respiratory depression
Periodo de tiempo: postoperative 1, 2, 3 days
|
Postoperative respiratory depression is defined as a sustained (>1 minute) decrease in oxygen saturation to <90%, or a respiratory rate of <8 breaths per minute, or a decrease in oxygen saturation to <94% accompanied by a respiratory rate of <10 breaths per minute, requiring supplemental oxygen to maintain oxygen saturation (SpO₂) >94%, and in the absence of obvious upper airway obstruction. |
postoperative 1, 2, 3 days
|
|
Rescue analgesia rate
Periodo de tiempo: postoperative 1, 2, 3 days
|
postoperative 1, 2, 3 days
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|
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Total dose of sufentanil for rescue analgesia
Periodo de tiempo: postoperative 1, 2, 3 days
|
postoperative 1, 2, 3 days
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|
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Time of first ambulation
Periodo de tiempo: postoperative 1, 2, 3 days
|
postoperative 1, 2, 3 days
|
|
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Total Hospital Stay
Periodo de tiempo: postoperative 7 days
|
postoperative 7 days
|
|
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Adverse effects
Periodo de tiempo: postoperative 1, 2, 3 days
|
postoperative 1, 2, 3 days
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- FirstAHXiamenU-YB-5
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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