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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Gangnam-gu
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Seoul, Gangnam-gu, Corea, república de, 06351
- Samsung Medical Center
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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:
-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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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mastectomy group
All patients who received the mastectomy (breast conserving surgery and sentinel lymph node dissection)
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All patients assessed postoperative pain score in the recovery room and postoperative 2 month
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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persistent pain
Periodo de tiempo: postoperative 2 months
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persistent postoperative pain after mastectomy (Numeric rating pain score (NSR: no pain=1, worst pain=10)
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postoperative 2 months
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acute postoperative pain
Periodo de tiempo: postoperative 1 hour
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acute postoperative pain in the recovery room measured by Numeric rating pain score (NSR: no pain=1, worst pain=10)
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postoperative 1 hour
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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inhalation agent
Periodo de tiempo: intraoperative
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inhalation anesthetics use or total intravenous anesthesia
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intraoperative
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opioid consumption
Periodo de tiempo: intraoperative
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the amount of opioid
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intraoperative
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surgical anxiety level
Periodo de tiempo: 1 day before surgery
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(0: not anxiety-100: extremely anxious)
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1 day before surgery
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anticipate pain
Periodo de tiempo: 1 day before surgery
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(0: no pain-100: a bad as you can imagine)
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1 day before surgery
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anticipated pain medication need
Periodo de tiempo: 1 day before surgery
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(0: none at all, 1: much less than average, 2: less than average, 3: average, 4: more than average, 5: much more than average)
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1 day before surgery
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surgery factor
Periodo de tiempo: intraoperative
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the incision size and the number of excision of lymph node
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intraoperative
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The surgical pleth index
Periodo de tiempo: intraoperative
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the highest surgical pleth index score in time of start anesthesia and ene of anesthesia
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intraoperative
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The pain score of discharge
Periodo de tiempo: on the 1 day of discharge
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Numeric rating pain score (NSR: no pain=1, worst pain=10)
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on the 1 day of discharge
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the consumption of postoperative analgesia
Periodo de tiempo: postoperative 72 hours
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the consumption of postoperative analgesia during in-hospital day
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postoperative 72 hours
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
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Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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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
- SMC2018-09-029-003
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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