The Effects of Anesthetics on Persistent Pain Following Breast Cancer Surgery
NCT ID: NCT03782896
Last Updated: 2020-01-31
Study Results
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Basic Information
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COMPLETED
89 participants
OBSERVATIONAL
2018-12-31
2019-12-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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mastectomy group
All patients who received the mastectomy (breast conserving surgery and sentinel lymph node dissection)
acute postoperative pain
All patients assessed postoperative pain score in the recovery room and postoperative 2 month
Interventions
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acute postoperative pain
All patients assessed postoperative pain score in the recovery room and postoperative 2 month
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
20 Years
70 Years
FEMALE
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Locations
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Samsung Medical Center
Seoul, Gangnam-gu, South Korea
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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SMC2018-09-029-003
Identifier Type: -
Identifier Source: org_study_id
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