Trials / Completed
CompletedNCT04309929
Description of the Analgesia Obtained With the Anesthesiological Protocols Currently Used in Breast Surgery
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (actual)
- Sponsor
- Careggi Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
Timeline
- Start date
- 2016-09-12
- Primary completion
- 2018-07-31
- Completion
- 2018-07-31
- First posted
- 2020-03-17
- Last updated
- 2020-03-17
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04309929. Inclusion in this directory is not an endorsement.