Continuous Serrates Plane Block in Axillary Dissection

A

Arcispedale Santa Maria Nuova-IRCCS

Status

Unknown

Conditions

Breast Cancer

Treatments

Procedure: Continuous serratus plane block

Study type

Interventional

Funder types

Other

Identifiers

NCT03992859
CIMPAX BREAST

Details and patient eligibility

About

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.

Full description

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.

Enrollment

84 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age > 18 breast surgery informed consent

Exclusion criteria

ASA >3 allergy to local anesthetic opioid administration in the last month patient refusal

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

84 participants in 2 patient groups

serratus catheter
Experimental group
Description:
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
Treatment:
Procedure: Continuous serratus plane block
standard treatment
No Intervention group
Description:
Post-operative multimodal analgesia with Acetaminophen and PCA of Morphine

Trial contacts and locations

1

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Central trial contact

Federico bizzarri; Federico bizzarri

Data sourced from clinicaltrials.gov

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