Breast Cancer Clinical Trial
Official title:
The Effects of Anesthetics on Persistent Pain Following Breast Cancer Surgery
Verified date | December 2018 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 89 |
Est. completion date | December 30, 2019 |
Est. primary completion date | December 5, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul | Gangnam-gu |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
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. — View Citation
Gärtner 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. — View Citation
Lefebvre-Kuntz D, Dualé C, Albi-Feldzer A, Nougarède 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. — View Citation
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. — View Citation
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):660-8. doi: 10.1016/j.pain.2012.11.015. Epub 2012 Dec 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | persistent pain | persistent postoperative pain after mastectomy (Numeric rating pain score (NSR: no pain=1, worst pain=10) | postoperative 2 months | |
Primary | acute postoperative pain | acute postoperative pain in the recovery room measured by Numeric rating pain score (NSR: no pain=1, worst pain=10) | postoperative 1 hour | |
Secondary | inhalation agent | inhalation anesthetics use or total intravenous anesthesia | intraoperative | |
Secondary | opioid consumption | the amount of opioid | intraoperative | |
Secondary | surgical anxiety level | (0: not anxiety-100: extremely anxious) | 1 day before surgery | |
Secondary | anticipate pain | (0: no pain-100: a bad as you can imagine) | 1 day before surgery | |
Secondary | anticipated pain medication need | (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 | |
Secondary | surgery factor | the incision size and the number of excision of lymph node | intraoperative | |
Secondary | The surgical pleth index | the highest surgical pleth index score in time of start anesthesia and ene of anesthesia | intraoperative | |
Secondary | The pain score of discharge | Numeric rating pain score (NSR: no pain=1, worst pain=10) | on the 1 day of discharge | |
Secondary | the consumption of postoperative analgesia | the consumption of postoperative analgesia during in-hospital day | postoperative 72 hours |
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