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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pectoral PECS II block | Experimental | Ultrasound-guided PECS II block with ropivacaine 0.75% 20 ml (patients N = 75) + Parasternal ultrasound-guided block at T2, T4 levels with ropivacaine 0.375% 10 ml |
|
| Paravertebral nerve block | Active Comparator | Ultrasound-guided paravertebral block with ropivacaine 0.75% 20 ml at T1-T2 and T3-T4 levels (10 ml each) (patients N = 75) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PECSII and paravertebral blocks | Procedure | Regional anesthesia for mastectomy outcomes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine requirement | Morphine self-administered by a patient controlled device | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain | Pain reporter by a numerical rating scale (NRS) 0-10 (0=no pain, 10=the worst imaginable pain) postoperatively | 2 days |
| Persistent Postsurgical pain (PPSP) | Pain reported by a a numerical rating scale (NRS) 0-10 (0=no pain, 10=the worst imaginable pain) in the follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| gianluca cappelleri, MD | AUSL IRCCS Reggio Emilia, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AUSL IRCCS Reggio Emilia | Reggio Emilia | 42120 | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 2 years |
| cancer recurrence | Incidence of cancer recurrence | 2 years |
| D017437 |
| Skin and Connective Tissue Diseases |