Description of the Analgesia Obtained With the Anesthesiological Protocols Currently Used in Breast Surgery
الكلمات الدالة
نبذة مختصرة
وصف
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.
تواريخ
| آخر التحقق: | 02/29/2020 |
| تم الإرسال لأول مرة: | 03/09/2020 |
| تم إرسال التسجيل المقدر: | 03/11/2020 |
| أول نشر: | 03/16/2020 |
| تم إرسال آخر تحديث: | 03/11/2020 |
| آخر تحديث تم نشره: | 03/16/2020 |
| تاريخ بدء الدراسة الفعلي: | 09/11/2016 |
| تاريخ الإنجاز الأساسي المقدر: | 07/30/2018 |
| التاريخ المتوقع لانتهاء الدراسة: | 07/30/2018 |
حالة أو مرض
التدخل / العلاج
Drug: Women with breast cancer
مرحلة
مجموعات الذراع
| ذراع | التدخل / العلاج |
|---|---|
| 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: Women with breast cancer 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. |
معايير الأهلية
| الأعمار المؤهلة للدراسة | 18 Years إلى 18 Years |
| الأجناس المؤهلة للدراسة | Female |
| طريقة أخذ العينات | Non-Probability Sample |
| يقبل المتطوعين الأصحاء | نعم |
| المعايير | 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); |
النتيجة
مقاييس النتائج الأولية
1. Assessment of the change of level of anesthesia [Up to 24 hours after surgery]
مقاييس النتائج الثانوية
1. Describing the total amount of morphine used in the first 24 post-operative hours. [24 hours after surgery]
2. Describing the incidence of PONV (Postoperative Nausea and Vomiting). [24 hours after surgery]
3. Describing of change in severity of PONV (Postoperative Nausea and Vomiting). [24 hours after surgery]
4. Description of the change of the intensity of pain on daily activities reported by patients undergoing breast surgery. [3 months after surgery]
5. Description of the change of the interference of pain on daily activities reported by patients undergoing breast surgery. [3 months after surgery]
6. Description of the change of the incidence and impact on daily activities of the pain reported by patients undergoing breast surgery. [3 months after surgery]
