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Catheter Redosing of Autonomic Neural Blockade After Sleeve Gastrectomy

13 de junio de 2026 actualizado por: Universidad Simón Bolívar

Targeted Temporary In Situ Catheter Redosing of Autonomic Neural Blockade for Breakthrough Symptoms After Laparoscopic Sleeve Gastrectomy

Postoperative visceral pain and autonomic symptoms after laparoscopic sleeve gastrectomy may reappear earlier in selected high-risk patients despite standard intraoperative autonomic neural blockade (ANB). Temporary in situ catheter placement permits postoperative ANB redosing when breakthrough visceral symptoms occur.

This prospective single-arm observational study will evaluate the feasibility, safety, and clinical effectiveness of temporary ANB catheter placement and selective postoperative redosing in high-risk patients undergoing laparoscopic sleeve gastrectomy.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Autonomic neural blockade (ANB) selectively modulates visceral pain and autonomic symptoms after minimally invasive upper gastrointestinal surgery. Prior randomized trials have demonstrated reductions in pain, analgesic requirements, PONV, and anesthetic consumption following ANB during laparoscopic sleeve gastrectomy (LSG). However, breakthrough visceral symptoms may occur in selected patients after blockade wanes.

A prior feasibility study by our group demonstrated that temporary in situ catheter placement for postoperative ANB redosing after LSG is technically feasible and safe, establishing catheter selection, placement strategy, and anatomical targets.

This prospective pilot study evaluates the clinical utility of selective postoperative ANB redosing in predefined high-risk patients.

All participants will undergo standard intraoperative ANB, TAP block, and temporary catheter placement in one of three anatomically validated paragastric/celiac pathway locations. Scheduled acetaminophen will be administered postoperatively.

Prior to any redosing, the treating investigator will clinically assess whether symptoms are consistent with visceral/autonomic breakthrough rather than somatic/incisional pain. Pain characteristics suggesting visceral origin include diffuse, deep, poorly localized epigastric/substernal discomfort, associated nausea/vomiting, autonomic symptoms, or pain disproportionate to abdominal wall tenderness.

Patients meeting redosing criteria will receive catheter redosing with 15 mL of 0.5% bupivacaine plus 4 mg dexamethasone. The minimum interval between re-dosing will be eight hours.

Concomitant hiatal hernia repair will be recorded for all patients, given the potential influence of distal phrenic nerve blockade on postoperative symptom patterns.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

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: Jorge Daes, MD
  • Número de teléfono: +57 3106363636
  • Correo electrónico: jorgedaez@gmail.com

Copia de seguridad de contactos de estudio

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:

Patients undergoing elective laparoscopic sleeve gastrectomy with one or more of the following risk factors for breakthrough visceral/autonomic symptoms:

  • Female sex age <30 years
  • Prior history of severe postoperative pain after abdominal surgery
  • Prior history of significant postoperative nausea/vomiting
  • History of opioid intolerance or significant opioid-related adverse effects
  • Allergy/intolerance to multiple postoperative analgesics/antiemetics
  • Concomitant hiatal hernia repair
  • Surgeon's judgment of elevated visceral symptom risk based on prior institutional experience

Exclusion Criteria:•

  • Contraindication to local anesthetics or dexamethasone
  • Chronic opioid dependence
  • Severe psychiatric or cognitive impairment limiting symptom assessment
  • Pregnancy
  • Conversion to open surgery
  • Inability or unwillingness to comply with the postoperative reporting protocol.

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Catheter Re-dosing for Breakthrough Symptoms After LSG
Participants with breakthrough symptoms, defined as visceral pain of 4/10 or higher, postoperative nausea, or vomiting, will receive 15 mL of bupivacaine 0.5% plus dexamethasone 4 mg through the temporary catheter. Symptom response will be recorded 15 minutes after administration. Catheter re-dosing may be repeated if breakthrough visceral/autonomic symptoms recur, provided that at least 8 hours have elapsed since the prior dose and the participant remains under direct institutional supervision. The catheter will be removed 24 hours postoperatively or before hospital discharge, whichever occurs first.
Otro: Bupivacaine 0.5% and Dexamethasone via Temporary Catheter
Autonomic neural blockade (ANB) re-dosing will be performed by administering bupivacaine 0.5% and dexamethasone through a temporary catheter placed in the paragastric area during laparoscopic sleeve gastrectomy

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Clinical Response to autonomic neural blockade(ANB) Redosing
Periodo de tiempo: Up to 24 hours postoperatively
Change in visceral pain score measured on a 10-point visual analog scale before and after autonomic neural blockade re-dosing. A clinically meaningful response is defined as a reduction of 2 or more points.
Up to 24 hours postoperatively
Resolution of Postoperative Nausea or Vomiting After ANB Re-dosing
Periodo de tiempo: Up to 24 hours postoperatively
Resolution of postoperative nausea or vomiting when present before autonomic neural blockade re-dosing, assessed as present or absent after treatment.
Up to 24 hours postoperatively
Proportion of Participants With Successful Temporary Catheter Placement and Function
Periodo de tiempo: Intraoperative through 24 hours postoperatively
Successful temporary catheter placement and function, assessed as a binary yes/no measure. Success is defined as intraoperative placement of the catheter in the intended paragastric location with catheter patency sufficient to allow postoperative administration of the study intervention if clinically indicated.
Intraoperative through 24 hours postoperatively

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of Clinically Significant Breakthrough Visceral Symptoms Despite Standard Intraoperative ANB
Periodo de tiempo: Up to 24 hours postoperatively
Proportion of enrolled patients requiring at least one postoperative catheter re-dosing.
Up to 24 hours postoperatively
Number of Re-dosing Events Per Patient
Periodo de tiempo: Up to 24 hours postoperatively
Total number of postoperative autonomic neural blockade catheter re-dosing episodes administered to each participant during the postoperative catheter-use period.
Up to 24 hours postoperatively
Safety of Temporary ANB Catheter Technique
Periodo de tiempo: 8 postoperative days

Incidence of catheter-related or ANB-related adverse events, including:

  • Bleeding
  • Infection
  • Catheter dysfunction requiring premature removal or preventing intended redosing.
8 postoperative days
Postoperative Pain Scores Compared with Historic Institutional Controls
Periodo de tiempo: 8, 24, and 48 hours postoperatively
Comparison of postoperative pain scores measured using the Visual Analog Scale for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain. Scores will be compared at 8, 24, and 48 hours after surgery with a prior institutional laparoscopic sleeve gastrectomy cohort managed under an identical perioperative protocol but without catheter placement or autonomic neural blockade re-dosing. In participants requiring re-dosing, pain scores obtained before rescue intervention will be used for comparison.
8, 24, and 48 hours postoperatively
Postoperative Nausea and Vomiting Compared with Historic Institutional Controls
Periodo de tiempo: 8, 24, and 48 hours postoperatively
Comparison of postoperative nausea and vomiting events at 8, 24, and 48 hours after surgery with a prior matched institutional laparoscopic sleeve gastrectomy cohort managed under an identical perioperative protocol but without catheter placement or ANB redosing. In patients requiring redosing, the presence of nausea or vomiting documented prior to rescue intervention will be used for comparison.
8, 24, and 48 hours postoperatively
Re-dosing Requirement by Concomitant Hiatal Hernia Repair Status
Periodo de tiempo: Up to 24 hours postoperatively.
Exploratory comparison of the proportion of participants requiring at least one postoperative catheter re-dosing between participants undergoing laparoscopic sleeve gastrectomy with versus without concomitant hiatal hernia repair.
Up to 24 hours postoperatively.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Universidad Simón Bolívar

Investigadores

  • Investigador principal: Jorge Daes, MD, clinica Iberoamerica

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

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)

15 de junio de 2026

Finalización primaria (Estimado)

1 de enero de 2027

Finalización del estudio (Estimado)

1 de febrero de 2027

Fechas de registro del estudio

Enviado por primera vez

29 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

13 de junio de 2026

Publicado por primera vez (Actual)

18 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

13 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CI0012026

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

We plan to share the study protocol, statistical analysis plan (SAP), informed consent form (ICF), and selected de-identified participant-level data upon reasonable academic request after publication of the study results.

Marco de tiempo para compartir IPD

Beginning 6 months after publication of the primary study results and continuing for up to 5 years.

Criterios de acceso compartido de IPD

De-identified individual participant data and supporting documents may be shared with qualified academic investigators upon reasonable request for scientific or educational purposes, following review and approval by the principal investigator and institution, and in accordance with patient confidentiality and institutional policies.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

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. .

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