Status:
COMPLETED
Description of the Analgesia Obtained With the Anesthesiological Protocols Currently Used in Breast Surgery
Lead Sponsor:
Careggi Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
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 opioi...
Detailed Description
Breast cancer is the second most common in the world and the most frequent in the female population. In Italy, around 48,000 new cases were diagnosed in 2013. Every year patients undergoing surgical p...
Eligibility Criteria
Inclusion
- 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
- 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);
Key Trial Info
Start Date :
September 12 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04309929
Start Date
September 12 2016
End Date
July 31 2018
Last Update
March 17 2020
Active Locations (1)
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1
Azienda Ospedaliero Universitaria Careggi
Florence, Italy, 50100