Clinical trial NCT04309929: Description of the Analgesia Obtained With the Anesthesiological Protocols Currently Used in Breast Surgery
Official title: Description of the Analgesia Obtained With the Anesthesiological Protocols Currently Used in Breast Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Cancer
Breast
Mastectomy
Lead sponsor: Careggi Hospital
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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 procedures in the region of the breast and armpit, like other surgical areas, report a significant incidence of acute postoperative pain which in 25-60% of cases can progress to chronic pain and therefore it needs a timely and effective control.

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.

Eligibility criteria: 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);

Primary outcomes:
measure: Assessment of the change of level of anesthesia
timeFrame: Up to 24 hours after surgery
Secondary outcomes:
measure: Describing the total amount of morphine used in the first 24 post-operative hours.
timeFrame: 24 hours after surgery
measure: Describing the incidence of PONV (Postoperative Nausea and Vomiting).
timeFrame: 24 hours after surgery
measure: Describing of change in severity of PONV (Postoperative Nausea and Vomiting).
timeFrame: 24 hours after surgery
measure: Description of the change of the intensity of pain on daily activities reported by patients undergoing breast surgery.
timeFrame: 3 months after surgery
measure: Description of the change of the interference of pain on daily activities reported by patients undergoing breast surgery.
timeFrame: 3 months after surgery
measure: Description of the change of the incidence and impact on daily activities of the pain reported by patients undergoing breast surgery.
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
Study officials:
affiliation: Careggi Hospital
name: Carmelo Guido, MD
role: PRINCIPAL_INVESTIGATOR
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