Description of the Analgesia Obtained With the Anesthesiological Protocols Currently Used in Breast Surgery

NCT04309929 | Completed

• 1 other identifier: CEAVC OSS. 16.246
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to describe the pain-relieving effect obtained with the current post-surgery pain control methods used in breast surgery by measuring the painful sensation and the consumption of opioids in the first 24 post-surgery hours. It also aims to describe the appearance of any complications such as post-surgery nausea and vomiting. Current anesthesia involves the combined use of intravenous painkillers and anti-inflammatory drugs such as acetaminophen, ketorolac, tramadol or morphine (the latter via PCA system = patient-controlled analgesia) or for local administration at the surgical site level ( local anesthetics). It is also proposed to describe the intensity and interference of pain in daily activities

Conditions

Breast Cancer

Keywords

Cancer; Breast; Mastectomy

Outcome Measures

Primary Outcomes (1)

• Assessment of the change of level of anesthesia

  Describing the level of analgesia obtained in the first 24 hours post-operative in patients undergoing simple mastectomy, mastectomy with immediate reconstruction with expander or retropectoral prosthesis, mastectomy with sentinel node biopsy and radical mastectomy modified with the anesthesiological protocols used routinariamentally. Analgesia will be evaluated every 6 hours and for the first 24 post-operative hours (at 0, 6, 12, 18, 24 hours from the end of the surgical intervention) through the NRS (Numerical Rating Scale). The Numerical Rating Scale is a pain sensation rating scale at points where the patient chooses a value ranging from 0 (no pain) to 10 (maximum pain). From 1 to 3 it is considered mild pain, from 4-7 moderate, from 8-10 severe.

  Up to 24 hours after surgery

Secondary Outcomes (6)

• Describing the total amount of morphine used in the first 24 post-operative hours.

  24 hours after surgery

• Describing the incidence of PONV (Postoperative Nausea and Vomiting).

  24 hours after surgery

• Describing of change in severity of PONV (Postoperative Nausea and Vomiting).

  24 hours after surgery

• Description of the change of the intensity of pain on daily activities reported by patients undergoing breast surgery.

  3 months after surgery

• Description of the change of the interference of pain on daily activities reported by patients undergoing breast surgery.

  3 months after surgery

Study Arms (1)

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)

Drug: Analgesics

Interventions

Analgesics DRUG

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.

Women with breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who in accordance with the inclusion and exclusion criteria have given their consent to the processing of personal data will be considered for analysis. All patients will undergo the anesthesiological and surgical treatment foreseen for the patient's clinical condition and in no case will the patients undergo a modification of the normal diagnostic-therapeutic path due to participation in this study.

You may qualify if:

• Female gender
• 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;

You may not qualify if:

• Known alterations of coagulation;
• 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);

Sponsors & Collaborators

• Careggi Hospital: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Careggi

Florence, 50100, Italy

Location

Related Publications (19)

• 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.

  PMID: 25887465 BACKGROUND

• 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.

  PMID: 15562083 BACKGROUND

• 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.

  PMID: 8826494 BACKGROUND

• Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027. Epub 2013 Feb 26.

  PMID: 23485231 BACKGROUND

• AIRTUM Working Group. Italian cancer figures, report 2013: Multiple tumours. Epidemiol Prev. 2013 Jul-Oct;37(4-5 Suppl 1):1-152. English, Italian.

  PMID: 24259384 BACKGROUND

• 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.

  PMID: 16298063 BACKGROUND

• 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.

  PMID: 21435953 BACKGROUND

• 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.

  PMID: 7487214 BACKGROUND

• 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.

  PMID: 21769470 BACKGROUND

• 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.

  PMID: 17006061 BACKGROUND

• 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.

  PMID: 20947592 BACKGROUND

• 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.

  PMID: 21831090 BACKGROUND

• 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.

  PMID: 22939099 BACKGROUND

• 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.

  PMID: 25282097 BACKGROUND

• 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.

  PMID: 23923989 BACKGROUND

• Sopena-Zubiria LA, Fernandez-Mere LA, Valdes Arias C, Munoz Gonzalez F, Sanchez Asheras J, Ibanez Ernandez C. [Thoracic paravertebral block compared to thoracic paravertebral block plus pectoral nerve block in reconstructive breast surgery]. Rev Esp Anestesiol Reanim. 2012 Jan;59(1):12-7. doi: 10.1016/j.redar.2011.10.001. Epub 2012 Mar 14. Spanish.

  PMID: 22429631 BACKGROUND

• 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.

  PMID: 25270861 BACKGROUND

• 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.

  PMID: 25376971 BACKGROUND

• 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.

  PMID: 33622393 DERIVED

Related Links

• Globocan 2012

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Analgesics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Carmelo Guido, MD

  Careggi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 17, 2020
• Study Start: September 12, 2016
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

IT (1)