Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients undergone to axillary dissection during breast surgery with a PECS I, II block will be randomized to receive either a serratus plane continuous local anesthetic infusion through a multiple hole catheter or nothing. Both groups will receive a patient controlled analgesia with morphine.
84 patients ASA I-III undergoing breast surgery with axillary dissection after modified PECS II block as described by Blanco et al. with Ropivacaine 0.37% 30 ml. General anesthesia with remifentanil 0.1 mcg/Kg/min and Propofol 1.5-2 mg/Kg to facilitate endotracheal intubation will provide for all patients, and maintained with Desflurane and Remifentanil infusion. In case of axillary dissection patient will be randomized to receive either a serratus plane continuous local anesthetic infusion through a multiple hole catheter or nothing. Both groups will receive as intraoperative analgesia 1 g Acetaminophene ev 30 minute before the end of the surgery and 1g. 8h-1 postoperative associated to a patient controlled analgesia with morphine. PCA will set up as follow: bolus 1 mg, lock-out 6 minute, max 20 mg/4h. In the serratus group 10 ml of Ropivacaine 0.5% before fascial closure and a continuous infusion of 12 ml/h of Ropivacaine 0.2% will be provide.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| serratus catheter | Experimental | Continuous serratus plane block: Ropivacaine 0.2% infusion through a multiple hole catheter (C-Cat Cimpax Denmark)at a fixed dose of 12 ml/h and a multimodal analgesia with acetaminophen and a PCA of morphine |
|
| standard treatment | No Intervention | Post-operative multimodal analgesia with Acetaminophen and PCA of Morphine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous serratus plane block | Procedure | Peripheral nerve catheter placed by the surgeon at the end of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption | A 70% reduction in morphine consumption in the continuous serratus plane block over control | 12-48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| persistent post-surgical pain: numerical rating scale | a numerical rating scale (0-10, 0= no pain, 10 = worst imaginable pain),> 4 | 3-6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Giorgio Francesco Danelli, MD | Azienda USL Reggio Emilia - IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ausl-Irccs Reggio Emilia | Reggio Emilia | RE | 42120 | Italy |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |