Breast Cancer
Conditions
Keywords
breast cancer, regional anesthesia, cancer recurrence
Brief summary
Patients scheduled for mastecotmy will be randomized to receive either an ultrasound-guided double space paravertebral block or a PECSII + parasternal block. In both groups, blocks will be performed with 20 ml of ropivacaine 0.75%, plus ropivacaine 0.375% 10 ml for parasternal block only. Postoperative, all patients will receive a morphine PCA. They will follow at 6, 12, 24 months for persistent postoperative surgical pain (PPSP) and cancer recurrence.
Detailed description
Patients scheduled for mastecotmy with or without axillary dissection, will be randomized to receive preoperative either an ultrasound-guided double space paravertebral block or a PECSII + parasternal block. In both groups, blocks will be performed with 20 ml of ropivacaine 0.75%, plus ropivacaine 0.375% 10 ml for parasternal block only. All the patients also received a general anesthesia induced by propofol and esmeron for endotracheal intubation and desflurane for maintaining. Sensory block by ice and pinprick test application and maximum spread after 40' from LA injection will be registered. Postoperative, all patients will receive a morphine PCA, ketorolac 30 mg/12h and paracetamol 1g each 8h. Morphine consumption will be registered. Patients will follow at 6, 12, 24 months for persistent postoperative surgical pain (PPSP) and cancer recurrence.
Interventions
PROCEDUREPECSII and paravertebral blocks
Regional anesthesia for mastectomy outcomes
Sponsors
Azienda USL Reggio Emilia - IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for radical mastectomy for cancer. * age \> 18 y-o * Written informed consent
Exclusion criteria
* Bilateral surgery * Opioids user * BMI \> 35 * Postoperative Intensive care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine requirement | 1 day | Morphine self-administered by a patient controlled device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain | 2 days | Pain reporter by a numerical rating scale (NRS) 0-10 (0=no pain, 10=the worst imaginable pain) postoperatively |
| Persistent Postsurgical pain (PPSP) | 2 years | Pain reported by a a numerical rating scale (NRS) 0-10 (0=no pain, 10=the worst imaginable pain) in the follow up |
| cancer recurrence | 2 years | Incidence of cancer recurrence |
Countries
Italy
Outcome results
None listed