- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03249766
Study of Prevalence of Ipsilateral Shoulder Pain in Patients After Thoracic Surgeries
Prospective Observational Study of Prevalence of Ipsilateral Shoulder Pain in Patients After Thoracic Surgeries
Descripción general del estudio
Descripción detallada
This will be a prospective observational study, which will be done over a period of one year (Upto 250 patients) after approval from ethics committee. The data of the first three months will be analysed (Upto 60 patients) and will presented as a thesis for MD (Anaesthesia). It will be carried out at Tata Memorial Centre, Mumbai. After Institutional Ethics Committee approval, Written informed consent in the language the patient understands the best will be obtained undergoing thoracic surgeries where the pleura is opened including Thoracotomy, Video Assisted Thoracic Surgeries (VATS). Data over a three months period will be collected. Pain at the incisional site and Ipsilateral shoulder pain (ISP) will be assessed separately using the numeric rating scale (NRS) during the patients' stay in the postanesthesia care unit (PACU) by an independent assessor, at 1 hour, 6 hours and 12 hours after coming to the PACU. The characteristics, intensity and pain at shoulder at rest and movement will also be assessed. Data including age, sex, BMI, American Society of Anesthesiologists (ASA) physical status, diagnosis, side and type of operation, surgical approach, positioning during surgery, duration of surgery, type of regional anesthesia, and, in patients with epidural anesthesia, level of catheter placement will also be recorded.
All male & female patients (aged 18-75 years) who undergo thoracic surgeries where the pleura is opened including Video Assisted Thoracic Surgeries (VATS)
EXCLUSION CRITERIA:
- presence of preoperative shoulder pain,
- preoperative shoulder pathology,
- use of analgesics for more than 1 week preoperatively,
- inability to understand the numeric rating scale(NRS)scoring system for pain assessment
- failure to extubate at the end of surgery.
- Patients who haven't given consent
- Age < 18yrs and > 75 yrs.
STATISTICAL ANALYSIS:
Since the study will be done over a period of twelve months, there is no sample size.
Continuous variables will be analyzed using independent t-test or Mann Whitney U test as per the distribution of the data for continuous variables. Categorical variables will be analyzed using Chi-square test or Fisher's exact test. P-value < 0.05 will be considered statistical significant. Risk factors of ISP will be analyzed using univariate and multivariate binary regression with robust estimates to calculate odds ratio (OR) and their 95% confidence interval. A manual stepwise forward logistic regression will be used to extract univariate independent variables. A p value ≤ 0.2 by univariate analysis will be used as the criterion for choosing variables to be included in the model for multivariate analysis. A p value <0.05 is considered statistically significant. Cut-off points of the independent variables, including age group and duration of surgery, are estimated by the method of maximum likelihood to achieve best discrimination between patients with and without ISP.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Maharashtra
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Mumbai, Maharashtra, India, 400025
- Tata Memorial Centre
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- All male & female patients (aged 18-75 years) who undergo thoracic surgeries where the pleura is opened including Video Assisted Thoracic Surgeries (VATS)
Exclusion Criteria:
- presence of preoperative shoulder pain,
- preoperative shoulder pathology,
- use of analgesics for more than 1 week preoperatively,
- inability to understand the numeric rating scale(NRS)scoring system for pain assessment
- failure to extubate at the end of surgery.
- Patients who haven't given consent
- Age < 18yrs and > 75 yrs.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Prevalence of Ipsilateral shoulder pain
Periodo de tiempo: Upto 12 hours post surgery
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Numeric rating scale within 12 hours post operative
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Upto 12 hours post surgery
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Raghu S Thota, MD, Tata Memorial 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 (Actual)
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
- 1900
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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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