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Prevention of Rebound Pain After Orthopaedic Surgery With Peripheral Nerve Block (REBOUND)_part B (REBOUND)

18 de junio de 2026 actualizado por: Eric Albrecht, Centre Hospitalier Universitaire Vaudois

Prevention of Rebound Pain After Orthopaedic Surgery With Peripheral Nerve Block: a Single-blinded Randomised Controlled Trial

Rebound pain after peripheral nerve blocks reduces the benefits of regional anesthesia and increases opioid consumption. This rebound pain most likely results from suboptimal pain management, as patients receiving a peripheral nerve block are typically not given scheduled opioid doses. Oral Patient Controlled Analgesia (PCA) consists of an oral morphine prescription that allows patients to self-administer doses based on their pain score.

This study will compare patients undergoing elective orthopaedic surgery under general anaesthesia or sedation with a peripheral nerve block, receiving oral morphine PCA either with or without additional scheduled oral morphine doses.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

This study contains two parts, one for the upper limb and one for the lower limb. Each part will be published independently.

This registration concerns the lower limb cohort.

Patients from each cohort (upper limb and lower limb) will be randomized into two groups of 25 patients each, for a total enrollment plan of 50 patients per cohort. After written informed consent, patients will be allocated to one of the two groups according to a computer-generated randomization list.

In the control group, morphine will be administered exclusively on demand via oral PCA,based on pain intensity assessed using a numeric rating scale (VAS > 4). For oral PCA, one10 mg morphine tablet is placed on the patient's bedside table by the nursing staff. When the patients experience pain, they may take the tablet autonomously and subsequently inform the nurse, who then prepares and places a new tablet at bedside for the next potential pain episode. No scheduled or prophylactic opioid administration will be provided in this group. The maximal allowed dose through oral PCA will be 6 tablets (10mg each) per 24-hour period.

In the intervention group, morphine will be administered at predefined regular intervals, starting immediately in the postoperative period in addition to the availability of oral PCA morphine as mentioned above. Scheduled doses of 20mg slow-release oral morphine will be given at fixed 12 hour intervals. Patients will therefore receive regular morphine to ensure continuous baseline analgesia while still having access to an additional tablet via oral PCA in case of breakthrough pain, following the same nursing procedure as in the control group.

In both groups, standardized multimodal analgesia will be provided

The primary objective of this study is to assess and compare the highest pain score within the first 24 postoperative hours between the two groups using the Visual Analog Scale (VAS). The secondary objective is to assess the effect of the intervention on postoperative pain and analgesic outcomes, including morphine consumption, pain scores, need for additional nerve blocks, incidence of chronic pain, duration of analgesia, postoperative side effects, complications, and hospital length of stay.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

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: Eric Albrecht, Prof.
  • Número de teléfono: +41 79 556 63 41
  • Correo electrónico: eric.albrecht@chuv.ch

Copia de seguridad de contactos de estudio

  • Nombre: Iliana Mrazek
  • Número de teléfono: +41 79 556 85 06
  • Correo electrónico: iliana.mrazek@chuv.ch

Ubicaciones de estudio

  • Suiza
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Suiza, 1000
        • CHUV, Centre Hospitalier Vaudois
        • Contacto:
        • Contacto:

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 scheduled for elective orthopaedic surgery on the upper limb
  • Patients scheduled for elective orthopaedic surgery on the lower limb.
  • Score ASA I-III; Patients aged over 18 years; Signed informed consent.
  • Surgery under general anaesthesia or under sedation

Exclusion Criteria:

  • Refusal or inability to understand the informed consent
  • Allergy to any of the following medications: ropivacaine, paracetamol, ibuprofen, ketorolac, morphine,sufentanil, ondansetron, or dexamethasone
  • Patients with long term opioid treatment
  • Bleeding diathesis
  • Neurological disorders of the operated limb
  • Known renal insufficiency (eGFR <30 mL/min)
  • Known hepatic insufficiency (Child-Pugh class B or C);
  • Pregnant or breastfeeding women;
  • Alcohol dependence syndrome;
  • Patients under spinal anaesthesia;
  • Patients undergoing amputation procedures

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: Scheduled group
Oral morphine administered at predefined regular intervals starting immediately after surgery, with additional access to oral PCA.
Droga: Morphine provided via oral PCA + morphine administered at a scheduled regimen
morphine will be administered according to a scheduled regimen (20mg slow-release oral morphine at fixed 12-hour intervals), with additional oral PCA on demand for breakthrough pain (VAS > 4), following the same bedside tablet procedure as in the control group. The maximum allowed dose through oral PCA will be 6 tablets (10mg each) per 24-hour period.
Comparador activo: On-demand group
Oral morphine administered on demand via PCA.
Droga: Morphine provided via oral PCA
Morphine will be administered according to a scheduled regimen (20mg slow release oral morphine at fixed 12-hour intervals), with additional oral PCA on demand for breakthrough pain (VAS > 4), following the same bedside tablet procedure as in the control group. The maximum allowed dose through oral PCA will be 6 tablets (10mg each) per 24-hour period.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Worst pain score during the first 24 hours after surgery
Periodo de tiempo: 24 hours postoperatively
Highest postoperative pain score during the first 24 hours after surgery, measured using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable
24 hours postoperatively

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Minimal pain score during the first 12 hours after surgery
Periodo de tiempo: 12 hours postoperatively
Lowest postoperative pain score during the first 12 hours after surgery, measured using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable
12 hours postoperatively
Persistence of pain
Periodo de tiempo: During the follow-up period from discharge till 4 weeks and 3 months
Incidence of persistent pain at 4 weeks and chronic pain at 3 months
During the follow-up period from discharge till 4 weeks and 3 months
Morphine consumption in the recovery room
Periodo de tiempo: from admission until discharge from the recovery room, up to 2 hours
consumption in mg
from admission until discharge from the recovery room, up to 2 hours
PCA administered morphine consumption at day 1, 2 and 3
Periodo de tiempo: Day 1, 2 and 3 postoperatively
Consumption in mg administered by PCA
Day 1, 2 and 3 postoperatively
Total administered morphine consumption at day 1, 2, and 3
Periodo de tiempo: Day 1, 2 and 3 postoperatively
Total consumption in mg
Day 1, 2 and 3 postoperatively
Incidence of postoperative nausea and vomiting
Periodo de tiempo: At 2 hours, day 1, day 2 and day 3 postoperatively
Presence of nausea or vomiting in the postoperative period
At 2 hours, day 1, day 2 and day 3 postoperatively
Incidence of pruritus
Periodo de tiempo: At 2 hours, day 1, day 2 and day 3 postoperatively
Presence of pruritus in the postoperative period
At 2 hours, day 1, day 2 and day 3 postoperatively
Incidence of urinary retention requiring bladder catheterisation
Periodo de tiempo: At 2 hours, day 1, day 2 and day 3 postoperatively
Urinary retention requiring catheterisation
At 2 hours, day 1, day 2 and day 3 postoperatively
Requirement for a new peripheral nerve block
Periodo de tiempo: On postoperative day 1, 2 and 3
Requirement for a new peripheral nerve block
On postoperative day 1, 2 and 3
Duration of analgesia
Periodo de tiempo: From the time the block is performed up to 36 hours after surgery
Time between block performance and the first dose of morphine
From the time the block is performed up to 36 hours after surgery
Rebound pain score measured using the Visual Analog Scale (VAS)
Periodo de tiempo: From surgery until 24 hours postoperatively
Rebound pain score calculated as the difference between the highest postoperative pain score within the first 24 hours after surgery and the lowest postoperative pain score within the first 12 hours after surgery. Pain intensity is assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher rebound pain scores indicate greater pain rebound
From surgery until 24 hours postoperatively
Rest and dynamic pain scores
Periodo de tiempo: At 2, 12, 24, 36, 48, 60, and 72 hours after surgery
Rest and dynamic pain scores, measured using a 0-10 Visual Analogue Score (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable
At 2, 12, 24, 36, 48, 60, and 72 hours after surgery
Incidence of severe pain
Periodo de tiempo: From surgery through 3 months after surgery
Pain evaluated at >7/10, measured using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable
From surgery through 3 months after surgery
Hospital length of stay
Periodo de tiempo: At hospital discharge (typically within 5 days, according to our hospital's standard practice)
Duration of hospitalization, measured as the number of days from surgery (baseline) to hospital discharge. Higher values indicate longer hospital stays.
At hospital discharge (typically within 5 days, according to our hospital's standard practice)

Colaboradores e Investigadores

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

Patrocinador

Centre Hospitalier Universitaire Vaudois

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

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)

1 de junio de 2026

Finalización primaria (Estimado)

1 de septiembre de 2027

Finalización del estudio (Estimado)

1 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

15 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de junio de 2026

Publicado por primera vez (Actual)

24 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de junio de 2026

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

18 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

  • 2026-00307_b

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. .

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