Description of the Analgesia Obtained With the Anesthesiological Protocols Currently Used in Breast Surgery
NCT ID: NCT04309929
Last Updated: 2020-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2016-09-12
2018-07-31
Brief Summary
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Detailed Description
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Breast surgery is associated with a high incidence of postoperative nausea and vomiting (PONV) whose etiology is multifactorial and includes factors such as age, type of intervention, positive history of PONV and, primarily, the amount of morphine used to ensure postoperative analgesia, the type of anesthesia and the intensity of postoperative pain.
The conventional anesthesiological approach to breast surgery involves the use of general anesthesia and postoperative analgesic therapy based on opiates and fans. Some techniques of locoregional anesthesia such as paravertebral block, thoracic peridural analgesia and intercostal block, associated with sedoanalgesia or general anesthesia, have joined the standard anesthesiological conduct helping to improve pain control, response to surgical stress, post-operative respiratory function, the incidence of thromboembolic events and it seems they can also contribute to reducing the incidence of distant metastases. In addition, making possible a reduced use of opiates further decrease the incidence of PONV. As part of this multimodal approach to anesthesia and analgesia for breast surgery, PECS Block I and II and the Serratus Plane Block (SPB) have recently been introduced into clinical practice.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Women with breast cancer
Female patients (age\> 18yrs) in ASA class \<4; candidate for a planned surgery for simple mastectomy, simple mastectomy with immediate reconstruction, mastectomy with sentinel node biopsy, modified radical mastectomy (unilateral or bilateral)
Analgesics
All patients will undergo the anesthesiological and surgical treatment provided for the patient's clinical conditions and in no case will the patients undergo a change in the normal diagnostic-therapeutic path due to participation in this study.
Interventions
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Analgesics
All patients will undergo the anesthesiological and surgical treatment provided for the patient's clinical conditions and in no case will the patients undergo a change in the normal diagnostic-therapeutic path due to participation in this study.
Eligibility Criteria
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Inclusion Criteria
* Age\> 18 years;
* Patients in ASA class \<4;
* Planned mastectomy surgery, simple mastectomy with immediate reconstruction, mastectomy with sentinel-lymph node biopsy, modified radical mastectomy (unilateral or bilateral);
* Absence of allergies or hypersensitivity reported and / or documented to drugs used routinely for post-operative analgesia;
* Absence of inflammatory changes at the surgical site level;
* Presence of the patient's informed consent to the processing of personal data;
Exclusion Criteria
* Known cardiac arrhythmias (atrial sinus block I, II, III type, atrioventricular block I, II and III type);
* Documented renal failure (patient undergoing renal replacement therapy, or creatininemia ≥ 2 mg / dl);
* Severe hepatic insufficiency (Child-Plugh class III and IV); Seizure states (absences, seizures of large and / or small epileptic disease);
* Respiratory failure (PaO2 ≤ 60mmHg PaCO2≥ 50mmHg);
18 Years
FEMALE
No
Sponsors
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Careggi Hospital
OTHER
Responsible Party
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Gianluca Villa
Principal investigator
Principal Investigators
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Carmelo Guido, MD
Role: PRINCIPAL_INVESTIGATOR
Careggi Hospital
Locations
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Azienda Ospedaliero Universitaria Careggi
Florence, , Italy
Countries
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References
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Gewandter JS, Dworkin RH, Turk DC, Farrar JT, Fillingim RB, Gilron I, Markman JD, Oaklander AL, Polydefkis MJ, Raja SN, Robinson JP, Woolf CJ, Ziegler D, Ashburn MA, Burke LB, Cowan P, George SZ, Goli V, Graff OX, Iyengar S, Jay GW, Katz J, Kehlet H, Kitt RA, Kopecky EA, Malamut R, McDermott MP, Palmer P, Rappaport BA, Rauschkolb C, Steigerwald I, Tobias J, Walco GA. Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations. Pain. 2015 Jul;156(7):1184-1197. doi: 10.1097/j.pain.0000000000000191.
Kairaluoma PM, Bachmann MS, Korpinen AK, Rosenberg PH, Pere PJ. Single-injection paravertebral block before general anesthesia enhances analgesia after breast cancer surgery with and without associated lymph node biopsy. Anesth Analg. 2004 Dec;99(6):1837-1843. doi: 10.1213/01.ANE.0000136775.15566.87.
Caraceni A, Mendoza TR, Mencaglia E, Baratella C, Edwards K, Forjaz MJ, Martini C, Serlin RC, de Conno F, Cleeland CS. A validation study of an Italian version of the Brief Pain Inventory (Breve Questionario per la Valutazione del Dolore). Pain. 1996 Apr;65(1):87-92. doi: 10.1016/0304-3959(95)00156-5.
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Katz J, Poleshuck EL, Andrus CH, Hogan LA, Jung BF, Kulick DI, Dworkin RH. Risk factors for acute pain and its persistence following breast cancer surgery. Pain. 2005 Dec 15;119(1-3):16-25. doi: 10.1016/j.pain.2005.09.008. Epub 2005 Nov 17.
Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24.
Lynch EP, Welch KJ, Carabuena JM, Eberlein TJ. Thoracic epidural anesthesia improves outcome after breast surgery. Ann Surg. 1995 Nov;222(5):663-9. doi: 10.1097/00000658-199511000-00009.
Aufforth R, Jain J, Morreale J, Baumgarten R, Falk J, Wesen C. Paravertebral blocks in breast cancer surgery: is there a difference in postoperative pain, nausea, and vomiting? Ann Surg Oncol. 2012 Feb;19(2):548-52. doi: 10.1245/s10434-011-1899-5. Epub 2011 Jul 16.
Exadaktylos AK, Buggy DJ, Moriarty DC, Mascha E, Sessler DI. Can anesthetic technique for primary breast cancer surgery affect recurrence or metastasis? Anesthesiology. 2006 Oct;105(4):660-4. doi: 10.1097/00000542-200610000-00008.
Schnabel A, Reichl SU, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of paravertebral blocks in breast surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2010 Dec;105(6):842-52. doi: 10.1093/bja/aeq265. Epub 2010 Oct 14.
Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.
Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
Bouzinac A, Tournier JJ, Merouani M, Delbos A. [Sensory blockade and efficiency of the "pec block 2" for postoperative analgesia after breast cancer surgery]. J Gynecol Obstet Biol Reprod (Paris). 2015 Jan;44(1):98-9. doi: 10.1016/j.jgyn.2014.09.004. Epub 2014 Oct 1. No abstract available. French.
Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
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Langford R, Brown I, Vickery J, Mitchell K, Pritchard C, Creanor S. Study protocol for a double blind, randomised, placebo-controlled trial of continuous subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy: SUB-pectoral Local anaesthetic Infusion following MastEctomy (SUBLIME) study. BMJ Open. 2014 Sep 30;4(9):e006318. doi: 10.1136/bmjopen-2014-006318.
Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
Villa G, Mandarano R, Scire-Calabrisotto C, Rizzelli V, Del Duca M, Montin DP, Paparella L, De Gaudio AR, Romagnoli S. Chronic pain after breast surgery: incidence, associated factors, and impact on quality of life, an observational prospective study. Perioper Med (Lond). 2021 Feb 24;10(1):6. doi: 10.1186/s13741-021-00176-6.
Related Links
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Globocan 2012
Other Identifiers
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CEAVC OSS. 16.246
Identifier Type: -
Identifier Source: org_study_id
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