Comprehensive Pain Programme to Determine Mechanism of Transition of Acute to Chronic Postsurgical Pain (TAHP)
Comprehensive Pain Programme to Determine Mechanism of Transition of Acute to Chronic Postsurgical Pain- Functional Brain Imaging, Quantitative Sensory Testing, Psychological and Genetic Screening: Prospective Cohort Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Chronic pain affects 9% of Singapore population resulting in major socioeconomic burden. Chronic postsurgical pain (CPSP) that persists for over 3 months could be related to nerve injury making this a strategic model to study the transition of acute to chronic pain. CPSP occurs in up to 50% after surgery and up to 32% after hysterectomy. Over 600000 hysterectomies were performed in the US in 2003 making CPSP a significant problem.
Investigators will perform this prospective cohort study to determine whether increased central sensitization and negative psychological experience are involved in the transition of acute to chronic pain after hysterectomy. Investigators will recruit 444 women undergoing hysterectomy and employ validated physical pain testing including tonic heat stimulation, mechanical temporal summation and wound hyperalgesia which had been shown to be related to central sensitization. Pain catastrophizing (negative thoughts of pain) and state trait anxiety scoring will be assessed for the impact of negative cognitive-affective experience on CPSP. A phone survey will be performed at 4 months to determine the primary outcome of CPSP. Arterial spin labeling will be used to delineate cerebral blood flow using arterial spin labeling, functional connectivity and structural connectivity to evaluate insula-anterior cingulate cortex differences in 30 women with CPSP compared to 30 women without CPSP.
In addition to evaluating whether central sensitization, negative psychological experience and activation of brain regions are different in women with CPSP after hysterectomy, the results of this study will elucidate potential mechanisms of CPSP development that will guide in future studies on potential novel therapeutic targets.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Singapore, Singapur, 229899
- KK Women's and Children's Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Anthropometric profile within the following range: age 21-70 yr, American Society of Anesthesiology status I and II women
- Benign condition such as fibroids or adenomyosis
- Abdominal or laparoscopic hysterectomy
Exclusion Criteria:
- Vaginal hysterectomy
- being pelvic pain
- Failure to adequately determine tonic heat stimulation and mechanical temporal summation
- History of drug dependence or recreational drug use
- Allergy to any study drugs
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: Cohort
pain testing.
All 444 subjects enrolled in the study.
Subjects will receive preoperative physical (tonic heat stimulation, mechanical temporal summation and wound hyperalgesia), psychological (State Trait Anxiety Inventory, Pain Catastrophizing Scale), and genetics test; postoperative pain score assessment at 24, 48 hours; postoperative wound hyperalgesia in open abdominal hysterectomy at 72 hours; and phone survey for CPSP at 4 months.
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physical testing, psychological testing, genetics testing and functional brain imaging
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Otro: Chronic Post-surgical Pain
pain testing.
physical testing, psychological testing, genetics testing and functional brain imaging
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physical testing, psychological testing, genetics testing and functional brain imaging
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Otro: No Chronic Post-surgical Pain
pain testing.
physical testing, psychological testing, genetics testing and functional brain imaging
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physical testing, psychological testing, genetics testing and functional brain imaging
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Chronic postsurgical pain (CPSP) after hysterectomy at 4 months on phone survey
Periodo de tiempo: 4 months post hysterectomy
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This is defined as pelvic pain (lower abdominal or perineal pain) in the last week that affected daily living during the 4 months phone survey.
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4 months post hysterectomy
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Chronic postsurgical pain (CPSP) after hysterectomy at 6 months on phone survey
Periodo de tiempo: 6 months post hysterectomy
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This is defined as pelvic pain (lower abdominal or perineal pain) in the last week that affected daily living during the 6 months phone survey.
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6 months post hysterectomy
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Pain Catastrophizing Scale
Periodo de tiempo: Upon recruitment till 6 months post hysterectomy
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Assessment will be done via Pain Catastrophizing Scale (PCS) questionnaire.
Pain catastrophizing refers to the negative thought processes patients have when they are exposed to pain or painful experiences.
The PCS is a 13-item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).
It is broken into three subscales being magnification (0-12), rumination (0-16), and helplessness (0-24).
A higher value in each subscale indicates a higher tendency to that subscale (worse outcome).
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Upon recruitment till 6 months post hysterectomy
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Mechanical Temporal Summation as measured by von Frey filament
Periodo de tiempo: 1 day (before surgery)
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Assessment will be done via Mechanical Temporal Summation assessment before surgery.
A 180 gram von Frey filament is applied on the subject's forearm.
Patient will then be asked to rate the pinprick pain score on a verbal rating scale, 0-100.
Following this, 10 consecutive touches at random locations are applied with a 1 second interstimulus interval and within a 1 cm diameter circle.
The patient will then be asked to rate the 10th pain score (0-100).
The Mechanical Temporal Summation Score is obtained by the difference between the 11th pain score and the 1st pain score.
If the score is greater than zero, the patient is implied to have presence of Mechanical Temporal Summation.
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1 day (before surgery)
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State Trait Anxiety Inventory
Periodo de tiempo: 1 day
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Assessment will be done via State Trait Anxiety Inventory (STAI) before surgery. STAI is a self-reported tool for assessing anxiety via two sub-scales, each containing 20 items on: i) the state anxiety sub-scale measuring transient anxiety at the time of scoring; and ii) trait anxiety measures dispositional anxiety or anxiety in general. Each item in STAI is rated on a 4-point scale: 1 (Not at all) to 4 (very much so). A higher value in each subscale indicates a higher tendency to that subscale (worse outcome on having greater state anxiety or trait anxiety). |
1 day
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ban Leong Sng, Dr, KK Women's and Children's Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimado)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2013/512/D
Plan de datos de participantes individuales (IPD)
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