- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03782896
The Effects of Anesthetics on Persistent Pain Following Breast Cancer Surgery
Persistent postoperative pain occurs up to 25 to 60 % after mastectomy. This occurs at a higher frequency than the rate of invasive surgery.Therefore, many ways have been tried to study risk factors. A study was conducted to predict postoperative pain for items (preoperative pain, sensitivity, pain prediction). As a result, it was reported that the scope of surgery, pre-operative pain, young age, and depression were associated with persistent pain.
This study try to find out whether persistent pain after mastectomy is affected anesthetic factors appropriate anesthesia depth and opioid using standardized monitoring devices limited to similar surgical ranges.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Persistent postoperative pain occurs up to 25 to 60 % after mastectomy. This occurs at a higher frequency than the rate of invasive surgery.Therefore, many ways have been tried to study risk factors. A study was conducted to predict postoperative pain for items (preoperative pain, sensitivity, pain prediction). As a result, it was reported that the scope of surgery, pre-operative pain, young age, and depression were associated with persistent pain.
There were reports of no association with anesthesia in the area of anesthesia to the high pain control requirement in the postoperative recovery room, 24 hours of high pain medication, use of inhalation agent, and a high dosage of remifentanil. However, an anesthesia-related study was either a retrospective study or anesthetic was injected with more than a clinical dose in order to make the difference following methods.
In this study, bispectral index is used to maintain anesthesia depth. In addition, the commercially available noninvasive pain depth equipment (Surgical Pleth Index) is used to assess the nociception-antinociception balance. Displays the automatically calculated values of SPI=100-(0.3*heartbeat interval + 0.7*photoplethysmographic pulse wave ampule) using a waveform with peripheral oxygen saturation. Through this process, patients want to objectify the amount of anesthetic agent used during surgery. And all patients are inserted the laryngeal mask airway.
This study would try find out whether persistent pain after mastectomy is affected anesthetic factors appropriate anesthesia depth and opioid using standardized monitoring devices limited to similar surgical ranges.
The investigators hypothesize that patients who suffered severe acute postoperative pain, regardless of their anesthesia method, have a higher incidence of persistent post-mastectomy pain.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Gangnam-gu
-
Seoul, Gangnam-gu, Republica da Coréia, 06351
- Samsung Medical Center
-
-
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:
-undergoing breast conserving surgery + sentinel lymph node dissection
Exclusion Criteria:
- cardiac arrythmia
- allergic history for drugs
- renal failure (Cr> 1.5 mg/dl)
- performing axillary lymph node dissection or Total mastectomy
- difficult airway and failed to place laryngeal mask airway properly
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
mastectomy group
All patients who received the mastectomy (breast conserving surgery and sentinel lymph node dissection)
|
All patients assessed postoperative pain score in the recovery room and postoperative 2 month
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
persistent pain
Prazo: postoperative 2 months
|
persistent postoperative pain after mastectomy (Numeric rating pain score (NSR: no pain=1, worst pain=10)
|
postoperative 2 months
|
|
acute postoperative pain
Prazo: postoperative 1 hour
|
acute postoperative pain in the recovery room measured by Numeric rating pain score (NSR: no pain=1, worst pain=10)
|
postoperative 1 hour
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
inhalation agent
Prazo: intraoperative
|
inhalation anesthetics use or total intravenous anesthesia
|
intraoperative
|
|
opioid consumption
Prazo: intraoperative
|
the amount of opioid
|
intraoperative
|
|
surgical anxiety level
Prazo: 1 day before surgery
|
(0: not anxiety-100: extremely anxious)
|
1 day before surgery
|
|
anticipate pain
Prazo: 1 day before surgery
|
(0: no pain-100: a bad as you can imagine)
|
1 day before surgery
|
|
anticipated pain medication need
Prazo: 1 day before surgery
|
(0: none at all, 1: much less than average, 2: less than average, 3: average, 4: more than average, 5: much more than average)
|
1 day before surgery
|
|
surgery factor
Prazo: intraoperative
|
the incision size and the number of excision of lymph node
|
intraoperative
|
|
The surgical pleth index
Prazo: intraoperative
|
the highest surgical pleth index score in time of start anesthesia and ene of anesthesia
|
intraoperative
|
|
The pain score of discharge
Prazo: on the 1 day of discharge
|
Numeric rating pain score (NSR: no pain=1, worst pain=10)
|
on the 1 day of discharge
|
|
the consumption of postoperative analgesia
Prazo: postoperative 72 hours
|
the consumption of postoperative analgesia during in-hospital day
|
postoperative 72 hours
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. Erratum In: JAMA. 2012 Nov 21;308(19):1973.
- Pan PH, Tonidandel AM, Aschenbrenner CA, Houle TT, Harris LC, Eisenach JC. Predicting acute pain after cesarean delivery using three simple questions. Anesthesiology. 2013 May;118(5):1170-9. doi: 10.1097/ALN.0b013e31828e156f.
- Schreiber KL, Martel MO, Shnol H, Shaffer JR, Greco C, Viray N, Taylor LN, McLaughlin M, Brufsky A, Ahrendt G, Bovbjerg D, Edwards RR, Belfer I. Persistent pain in postmastectomy patients: comparison of psychophysical, medical, surgical, and psychosocial characteristics between patients with and without pain. Pain. 2013 May;154(5):660-668. doi: 10.1016/j.pain.2012.11.015. Epub 2012 Dec 5.
- Cui L, Fan P, Qiu C, Hong Y. Single institution analysis of incidence and risk factors for post-mastectomy pain syndrome. Sci Rep. 2018 Jul 31;8(1):11494. doi: 10.1038/s41598-018-29946-x.
- Lefebvre-Kuntz D, Duale C, Albi-Feldzer A, Nougarede B, Falewee MN, Ouchchane L, Soule-Sonneville S, Bonneau J, Dubray C, Schoeffler P. General anaesthetic agents do not influence persistent pain after breast cancer surgery: A prospective nationwide cohort study. Eur J Anaesthesiol. 2015 Oct;32(10):697-704. doi: 10.1097/EJA.0000000000000215.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SMC2018-09-029-003
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .