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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Gangnam-gu
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Seoul, Gangnam-gu, Corée, République de, 06351
- Samsung Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
persistent pain
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
inhalation agent
Délai: intraoperative
|
inhalation anesthetics use or total intravenous anesthesia
|
intraoperative
|
|
opioid consumption
Délai: intraoperative
|
the amount of opioid
|
intraoperative
|
|
surgical anxiety level
Délai: 1 day before surgery
|
(0: not anxiety-100: extremely anxious)
|
1 day before surgery
|
|
anticipate pain
Délai: 1 day before surgery
|
(0: no pain-100: a bad as you can imagine)
|
1 day before surgery
|
|
anticipated pain medication need
Délai: 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
Délai: intraoperative
|
the incision size and the number of excision of lymph node
|
intraoperative
|
|
The surgical pleth index
Délai: intraoperative
|
the highest surgical pleth index score in time of start anesthesia and ene of anesthesia
|
intraoperative
|
|
The pain score of discharge
Délai: 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
Délai: postoperative 72 hours
|
the consumption of postoperative analgesia during in-hospital day
|
postoperative 72 hours
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SMC2018-09-029-003
Plan pour les données individuelles des participants (IPD)
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