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Analgesia With Transdermal Buprenorphine Patch in Adults Undergoing Video-Assisted Thoracoscopic Surgery

24 de julio de 2026 actualizado por: Clínica Dávila

Analgesia With a 5 mcg/Hour Transdermal Buprenorphine Patch as Part of Multimodal Analgesia in Adults Undergoing Unilateral Video-Assisted Thoracoscopic Surgery: A Triple-Blind Randomized Controlled Trial

Postoperative pain remains a major challenge after video-assisted thoracoscopic surgery (VATS), despite the use of multimodal analgesia. This randomized, triple-blind, placebo-controlled clinical trial will evaluate whether adding a 5 mcg/hour transdermal buprenorphine patch to the standard multimodal analgesic regimen reduces postoperative pain in adults undergoing unilateral VATS. Participants will be randomly assigned to receive either transdermal buprenorphine or placebo in addition to standard analgesia. Postoperative pain will be assessed at 24, 48, and 72 hours and 7 days after surgery. Secondary outcomes include opioid rescue requirements, length of hospital stay, postoperative nausea and vomiting, pruritus, and urinary retention.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Video-assisted thoracoscopic surgery (VATS) is associated with moderate to severe postoperative pain that may impair respiratory function, delay recovery, prolong hospitalization, and contribute to the development of persistent postoperative pain. Current guidelines recommend multimodal analgesia, including non-opioid analgesics and regional anesthesia techniques, while opioids are generally reserved for rescue analgesia.

Transdermal buprenorphine is a long-acting partial μ-opioid receptor agonist that has demonstrated efficacy in reducing postoperative pain and opioid consumption in several surgical settings. However, evidence regarding its use in thoracic surgery is currently lacking.

This is a single-center, randomized, triple-blind, placebo-controlled clinical trial conducted at Clínica Dávila, Santiago, Chile. Adult patients undergoing unilateral video-assisted thoracoscopic surgery will be randomized in a 1:1 ratio to receive either a 5 mcg/hour transdermal buprenorphine patch plus standard multimodal analgesia or placebo plus standard multimodal analgesia. Randomization will be computer-generated using sequentially numbered opaque sealed envelopes. Participants, investigators, outcome assessors, and the statistician will remain blinded to treatment allocation.

The primary outcome is postoperative pain intensity measured using the Numeric Rating Scale (0-10) at 24, 48, and 72 hours and 7 days after surgery. Secondary outcomes include opioid rescue consumption expressed as morphine equivalents, postoperative nausea and vomiting, pruritus, urinary retention, and length of hospital stay. The planned sample size is 90 participants (45 per group).

Tipo de estudio

Intervencionista

Inscripción (Estimado)

90

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.

Ubicaciones de estudio

  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 8431657
        • Reclutamiento
        • Clínica Dávila
        • Contacto:
        • Contacto:
          • Bernarda Miranda, Bibliotecary
          • Número de teléfono: +56930363776
          • Correo electrónico: bmiranda@davila.cl

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.
  • Scheduled for elective unilateral video-assisted thoracoscopic surgery (VATS).
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Able to understand the study procedures and provide written informed consent.

Exclusion Criteria:

  • Known allergy or hypersensitivity to buprenorphine or any component of the transdermal patch.
  • Chronic opioid use before surgery.
  • Severe hepatic impairment.
  • Pregnancy or breastfeeding.
  • Inability to complete postoperative pain assessments.
  • Any condition that, in the investigator's opinion, could interfere with study participation or outcome assessment.

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: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Buprenorphine Patch
Participants will receive a 5 mcg/hour transdermal buprenorphine patch before surgery in addition to standard multimodal analgesia.
Droga: Buprenorphine (BUP)
Transdermal buprenorphine patch (5 mcg/hour) administered preoperatively as part of multimodal analgesia.
Comparador de placebos: Placebo Patch
Participants will receive a placebo transdermal patch before surgery in addition to standard multimodal analgesia.
Otro: Placebo
Placebo transdermal patch identical in appearance to the active patch and administered preoperatively as part of multimodal analgesia.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative Pain Intensity Measured Using the Numeric Rating Scale
Periodo de tiempo: 24, 48, and 72 hours and 7 days after surgery
Postoperative pain intensity will be assessed using the Numeric Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be compared between the buprenorphine and placebo groups across the postoperative assessment time points.
24, 48, and 72 hours and 7 days after surgery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative Rescue Opioid Consumption
Periodo de tiempo: From the end of surgery through 7 days after surgery
Total rescue opioid consumption will be obtained from the clinical record and expressed in milligrams of intravenous morphine equivalents. Opioid consumption will be compared between the study groups.
From the end of surgery through 7 days after surgery
Incidence of Postoperative Nausea and Vomiting
Periodo de tiempo: 24, 48, and 72 hours and 7 days after surgery
The presence or absence of postoperative nausea or vomiting will be recorded at each postoperative assessment. The outcome will be reported as the number and percentage of participants experiencing nausea or vomiting in each study group.
24, 48, and 72 hours and 7 days after surgery
Incidence of Postoperative Pruritus
Periodo de tiempo: 24, 48, and 72 hours and 7 days after surgery
The presence or absence of postoperative pruritus will be recorded at each assessment. The outcome will be reported as the number and percentage of participants experiencing pruritus in each study group.
24, 48, and 72 hours and 7 days after surgery
Incidence of Postoperative Urinary Retention Requiring Bladder Catheterization
Periodo de tiempo: 24, 48, and 72 hours and 7 days after surgery
Postoperative urinary retention will be defined as the need for bladder catheterization. The outcome will be reported as the number and percentage of participants requiring catheterization in each study group.
24, 48, and 72 hours and 7 days after surgery
Length of Hospital Stay
Periodo de tiempo: From the day of surgery until hospital discharge, assessed up to 30 days
Length of hospital stay will be calculated as the number of complete days from the postoperative period until hospital discharge, based on the electronic clinical record.
From the day of surgery until hospital discharge, assessed up to 30 days

Colaboradores e Investigadores

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

Patrocinador

Clínica Dávila

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 (Actual)

1 de marzo de 2026

Finalización primaria (Estimado)

1 de marzo de 2027

Finalización del estudio (Estimado)

1 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

24 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de julio de 2026

Publicado por primera vez (Actual)

29 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de julio de 2026

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

24 de julio de 2026

Última verificación

1 de enero de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CD2025/035

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data will not be shared because the study protocol does not include a data-sharing plan. Study data will be anonymized, securely stored, and used exclusively for the purposes described in the approved research protocol, in accordance with applicable ethical and institutional requirements.

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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