Continuous Serrates Plane Block in Axillary Dissection

Not Applicable

• Conditions: Breast Cancer
• Interventions: Procedure: Continuous serratus plane block

• Registration Number: NCT03992859
• Lead Sponsor: Arcispedale Santa Maria Nuova-IRCCS

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-06-13
• Study First Submitted: 2018-11-14
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-19
• Last Update Submitted: 2019-06-19
• Study First Posted: 2019-06-20
• Last Update Posted: 2019-06-20
• Primary Completion: 2019-11-13
• Study Completion: 2020-06-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• age > 18
• breast surgery
• informed consent

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
serratus catheter	Continuous serratus plane block	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

Primary Outcome Measures

Name	Time	Method
Morphine consumption	12-48 hours	A 70% reduction in morphine consumption in the continuous serratus plane block over control

Secondary Outcome Measures

Name	Time	Method
persistent post-surgical pain: numerical rating scale	3-6 months	a numerical rating scale (0-10, 0= no pain, 10 = worst imaginable pain),\> 4

Trial Locations

Locations (1)

Ausl-Irccs Reggio Emilia; 🇮🇹 Reggio Emilia, RE, Italy