Incidence and Clinical Features of Breakthrough Pain After Brachial Plexus Block in Diabetic Patients
An Observational Study on Incidence and Clinical Characteristics of Breakthrough Pain Following Brachial Plexus Block in Adult Patients With Diabetes Mellitus
This observational study aims to determine the incidence and clinical characteristics of rebound-breakthrough pain after ultrasound-guided brachial plexus block in adult patients with type 2 diabetes mellitus. Adult patients undergoing elective upper-extremity surgery are divided into a type 2 diabetes group and a non-diabetic control group. Baseline clinical data and pain-related outcomes are collected after nerve block. This work may provide evidence for optimizing perioperative pain management for diabetic patients receiving brachial plexus block.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Descripción detallada
Background: Diabetes mellitus is a highly prevalent chronic disease worldwide. Diabetic peripheral neuropathy is one of its common complications, which may alter peripheral nerve function and pain perception. Brachial plexus block is widely used for upper-limb surgery. Rebound-breakthrough pain is a clinically important adverse event after peripheral nerve block, which worsens postoperative recovery and increases opioid consumption. The incidence and clinical features of this pain among patients with type 2 diabetes remain unclear.
This observational study enrolls adult patients undergoing elective upper-extremity surgery with ultrasound-guided brachial plexus block. Participants are separated into two groups: patients with type 2 diabetes mellitus and patients without diabetes. All patients receive routine clinical anesthesia with 0.375% ropivacaine for brachial plexus block without any experimental intervention. Pre-operative baseline information includes demographic data, glycosylated hemoglobin, diabetic history, and sensory threshold measurement. Post-block data including pain scores, onset and recovery time of sensory-motor block, patient-controlled analgesia usage and additional analgesic consumption are recorded.
The primary objective is to calculate the incidence of postoperative breakthrough-rebound pain. Secondary objectives cover pain severity, onset and duration of breakthrough pain, and perioperative analgesic consumption. Collected data will be summarized and analyzed to describe clinical characteristics associated with breakthrough pain.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Wen bo Wang
- Número de teléfono: +8618636532676
- Correo electrónico: 1525565253@qq.com
Ubicaciones de estudio
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Taiyuan, Porcelana
- Reclutamiento
- Second Hospital of Shanxi Medical University
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Contacto:
- Zheng Guo
- Número de teléfono: +863513365790
- Correo electrónico: guozheng713@yahoo.com
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Adult patients receiving ultrasound-guided brachial plexus block for elective upper-extremity surgery. Subjects are divided into two cohorts: patients with type 2 diabetes mellitus and non-diabetic patients. Routine clinical anesthesia management is adopted without experimental interventions.
Descripción
Inclusion Criteria:
- Aged 18 years or older
- Undergoing elective upper-extremity surgery
- Planned for ultrasound-guided brachial plexus block with 0.375% ropivacaine
- Able to cooperate with pain assessment and follow-up within 48 hours after block
- Written informed consent obtained
Exclusion Criteria:
- Allergy or contraindication to amide-type local anesthetics
- Pre-existing peripheral neuropathy of the affected upper limb
- Chronic regular use of opioids before surgery
- Coagulopathy or infection at the block puncture site
- Cognitive dysfunction unable to complete NRS pain evaluation
- Pregnancy or lactation
- Incomplete clinical data expected during follow-up
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: CROSS_SECTIONAL
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
|---|
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Patients with type 2 diabetes mellitus
Adult patients diagnosed with type 2 diabetes mellitus undergoing elective upper-extremity surgery with ultrasound-guided brachial plexus block. All subjects receive routine clinical anesthesia with 0.375% ropivacaine without experimental intervention. |
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Patients without diabetes mellitus
Adult non-diabetic patients undergoing elective upper-extremity surgery with ultrasound-guided brachial plexus block. All subjects receive routine clinical anesthesia with 0.375% ropivacaine without experimental intervention. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of postoperative rebound-breakthrough pain
Periodo de tiempo: Within 48 hours after brachial plexus block
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Proportion of participants developing rebound-breakthrough pain within 48 hours after brachial plexus block.Rebound-breakthrough pain after peripheral nerve block is characterized by sudden severe pain (NRS ≥ 7) occurring within 24 hours after block resolution. It is typically burning in nature, may occur at rest or during movement, lasts more than 2 hours, and most frequently develops 12-24 hours postoperatively. |
Within 48 hours after brachial plexus block
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Within 48 hours after brachial plexus block
Periodo de tiempo: Within 48 hours after block
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Peak numerical rating scale (NRS, 0-10) score during each rebound-breakthrough pain episode. Higher score indicates more severe pain. |
Within 48 hours after block
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Onset time of first rebound-breakthrough pain
Periodo de tiempo: Within 48 hours after block
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Time interval from completion of brachial plexus block to the first occurrence of rebound-breakthrough pain. |
Within 48 hours after block
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Frequency of rebound-breakthrough pain episodes
Periodo de tiempo: Within 48 hours after block
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Total number of rebound-breakthrough pain episodes within 48 hours after brachial plexus block. |
Within 48 hours after block
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Duration of each rebound-breakthrough pain episode
Periodo de tiempo: Within 48 hours after block
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Duration of each rebound-breakthrough pain episode that occurs within 48 hours after brachial plexus block. |
Within 48 hours after block
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Director de estudio: Li li Wang, Second Hospital of Shanxi Medical University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades del sistema endocrino
- Complicaciones Postoperatorias
- Procesos Patológicos
- Enfermedades metabólicas
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Dolor Postoperatorio
- Diabetes Mellitus, Tipo 2
Otros números de identificación del estudio
Otros números de identificación del estudio
- [2025]YX277
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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