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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
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Gangnam-gu
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Seoul, Gangnam-gu, Korea, Republikken, 06351
- Samsung Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
persistent pain
Tidsramme: postoperative 2 months
|
persistent postoperative pain after mastectomy (Numeric rating pain score (NSR: no pain=1, worst pain=10)
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postoperative 2 months
|
|
acute postoperative pain
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
inhalation agent
Tidsramme: intraoperative
|
inhalation anesthetics use or total intravenous anesthesia
|
intraoperative
|
|
opioid consumption
Tidsramme: intraoperative
|
the amount of opioid
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intraoperative
|
|
surgical anxiety level
Tidsramme: 1 day before surgery
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(0: not anxiety-100: extremely anxious)
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1 day before surgery
|
|
anticipate pain
Tidsramme: 1 day before surgery
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(0: no pain-100: a bad as you can imagine)
|
1 day before surgery
|
|
anticipated pain medication need
Tidsramme: 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
Tidsramme: intraoperative
|
the incision size and the number of excision of lymph node
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intraoperative
|
|
The surgical pleth index
Tidsramme: intraoperative
|
the highest surgical pleth index score in time of start anesthesia and ene of anesthesia
|
intraoperative
|
|
The pain score of discharge
Tidsramme: 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
Tidsramme: postoperative 72 hours
|
the consumption of postoperative analgesia during in-hospital day
|
postoperative 72 hours
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SMC2018-09-029-003
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