- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01392248
Prediction of Pain After Breast Cancer Surgery With EEG
EEG as a Predictor for Postoperative Pain and the Development of Chronic Postsurgical Pain After Breast Cancer Surgery
- Rationale The inter-individual pain experience immediately after surgery is considerable. In addition, a number of patients develop chronic post surgery pain (CPSP). Patients undergoing surgery for breast cancer are at risk of developing both acute post surgical pain as well as CPSP. Recently, in a group of patients with chronic back pain, it was demonstrated how subjectively reported pain is associated with specific electroencephalography (EEG) parameters, namely the N2 and P3 components of the pain event-related potential (ERP). It was concluded that ERP was associated with self-reported pain in daily life up to two weeks after the measurement. This resulted in the current hypothesis that EEG may be a predictor for postoperative pain.
Study design Prospective cohort study. Within 2 weeks before surgery, 150 patients will undergo an EEG measurement with five 'vulnerability' tasks. The experiment will be repeated 6 months postoperatively.
Study population: Female patients with breast cancer who will undergo breast surgery, between the ages of 18 to 65 years.
- Main study parameters/endpoints Primary outcome is postoperative pain, measured in a pain diary 4 days postoperatively. Secondary outcomes are development of chronic post surgery pain and quality of life. The main goal is to develop a comprehensive prediction model for acute and chronic postoperative pain after breast cancer surgery, based on the EEG results of the five vulnerability experiments.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Limburg
-
Maastricht, Limburg, Holanda, 6200 MD
- Maastricht UMC
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Age 18 - 65 years.
- ASA 1-2.
- Sufficient comprehension of the Dutch spoken and written language.
- Elective curative breast cancer surgery, both mastectomy and breast- conserving therapy
- Stage I and II breast cancer.
- Written informed consent is obtained
Exclusion Criteria:
- Previous breast surgery, both ipsilateral and contralateral.
- Stage III-IV breast cancer.
- Chronic pain (>3months) with an average severity of at least a VAS score 4 during the last two weeks.
- Chronic pain for which invasive treatment is needed.
- Use of (weak / strong) opioids in the last week.
- A history of opioid addiction.
- Regular use of the following medications in the last year:
antiepileptics,antipsychotics and anxiolytics.
- ASA 3 or higher.
- Consumption of alcohol (>4 units) and / or drugs the evening before.
- Alcohol consumption (>= 5 units/day).
- Illiteracy, problems with self expression, language barrier.
- Serious vision and / or hearing problems, interfering the performance of the experimental tasks.
- A history of psychiatric complaints and/or epilepsy .
- A medical history of CVA or TIA.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Acute postoperative pain
Prazo: during 4 days after surgery
|
VAS measured in a daily pain diary
|
during 4 days after surgery
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Quality of Life
Prazo: within 2 weeks before surgery and at 3,6 and 12 months postoperatively
|
Quality of Life measured with SF-36
|
within 2 weeks before surgery and at 3,6 and 12 months postoperatively
|
Development of chronic pain
Prazo: at 3,6 and 12 months postoperatively
|
Brief Pain Inventory
|
at 3,6 and 12 months postoperatively
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: M. A Marcus, Prof. Dr., Maastricht University Medical Center
- Investigador principal: J. van Os, Prof. Dr., Maastricht University Medical Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NL34275.068.11 / MEC 11-2-006
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Câncer de mama
-
Turku University HospitalLounais-Suomen SyöpäyhdistysAinda não está recrutandoSobrevivente de cancerFinlândia
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RetiradoSobrevivente de cancerEstados Unidos
-
University of Alabama at BirminghamNational Cancer Institute (NCI); Auburn UniversityConcluído
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)ConcluídoSobrevivente de cancerEstados Unidos
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)ConcluídoSobrevivente de cancerEstados Unidos, Guam
-
Wake Forest University Health SciencesNational Cancer Institute (NCI); National Institute of Mental Health (NIMH)ConcluídoSobrevivente de cancerEstados Unidos
-
Masonic Cancer Center, University of MinnesotaConcluídoSobrevivente de cancerEstados Unidos
-
Abramson Cancer Center of the University of PennsylvaniaConcluídoPlano de cuidados de sobrevivência LIVESTRONG: coleta contínua de dados e pesquisa de acompanhamentoPaciente com cancerEstados Unidos
-
University of New MexicoNew Mexico State University; University of New Mexico Cancer CenterConcluído
-
Ohio State University Comprehensive Cancer CenterConcluídoSobrevivente de cancerEstados Unidos