NCT03992859

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2019

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

1.8 years

First QC Date

November 14, 2018

Last Update Submit

June 20, 2025

Conditions

Breast Cancer

Keywords

regional anesthesia

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    A 70% reduction in morphine consumption in the continuous serratus plane block over control

    12-48 hours

Secondary Outcomes (1)

  • persistent post-surgical pain: numerical rating scale

    3-6 months

Study Arms (2)

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

Procedure: Continuous serratus plane block

standard treatment

NO INTERVENTION

Post-operative multimodal analgesia with Acetaminophen and PCA of Morphine

Interventions

Continuous serratus plane blockPROCEDURE

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

serratus catheter

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18
  • breast surgery
  • informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ausl-Irccs Reggio Emilia

Reggio Emilia, RE, 42120, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Giorgio Francesco Danelli, MD

    Azienda USL Reggio Emilia - IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2018

First Posted

June 20, 2019

Study Start

January 12, 2018

Primary Completion

November 13, 2019

Study Completion

December 30, 2021

Last Updated

June 25, 2025

Record last verified: 2025-06

Locations

IT(1)