Continuous Serrates Plane Block in Axillary Dissection

NCT ID: NCT03992859

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-12
• Study Completion Date: 2021-12-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

serratus catheter

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

Group Type: EXPERIMENTAL

Continuous serratus plane block

Intervention Type: PROCEDURE

Peripheral nerve catheter placed by the surgeon at the end of surgery

standard treatment

Post-operative multimodal analgesia with Acetaminophen and PCA of Morphine

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Continuous serratus plane block

Peripheral nerve catheter placed by the surgeon at the end of surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• age > 18
• breast surgery
• informed consent

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giorgio Francesco Danelli, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda USL Reggio Emilia - IRCCS

Locations

Ausl-Irccs Reggio Emilia

Reggio Emilia, RE, Italy

Countries

Italy

Other Identifiers

CIMPAX BREAST

Identifier Type: -

Identifier Source: org_study_id