Clinical trial · Observational
Description of the Analgesia Obtained With the Anesthesiological Protocols Currently Used in Breast Surgery
NCT04309929CI-TRIAL-00044069completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Analgesics | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women with breast cancer
- description
- 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)
- interventionNames
- Drug: Analgesics
Primary outcomes (1)
- measure
- Assessment of the change of level of anesthesia
- timeFrame
- Up to 24 hours after surgery
- description
- 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.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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; Exclusion Criteria: * 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);
References
Publications (19)
- BACKGROUNDGewandter 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
- BACKGROUNDKairaluoma 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
- BACKGROUNDCaraceni 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
- BACKGROUNDFerlay 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
- BACKGROUNDAIRTUM 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
- BACKGROUNDKatz 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.