NCT03941223

Brief Summary

Patients scheduled for mastecotmy will be randomized to receive either an ultrasound-guided double space paravertebral block or a PECSII + parasternal block. In both groups, blocks will be performed with 20 ml of ropivacaine 0.75%, plus ropivacaine 0.375% 10 ml for parasternal block only. Postoperative, all patients will receive a morphine PCA. They will follow at 6, 12, 24 months for persistent postoperative surgical pain (PPSP) and cancer recurrence.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2019

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

May 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

May 29, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

4.6 years

First QC Date

May 6, 2019

Last Update Submit

June 20, 2025

Conditions

Breast Cancer

Keywords

breast cancer, regional anesthesia, cancer recurrence

Outcome Measures

Primary Outcomes (1)

  • Morphine requirement

    Morphine self-administered by a patient controlled device

    1 day

Secondary Outcomes (3)

  • postoperative pain

    2 days

  • Persistent Postsurgical pain (PPSP)

    2 years

  • cancer recurrence

    2 years

Study Arms (2)

pectoral PECS II block

EXPERIMENTAL

Ultrasound-guided PECS II block with ropivacaine 0.75% 20 ml (patients N = 75) + Parasternal ultrasound-guided block at T2, T4 levels with ropivacaine 0.375% 10 ml

Procedure: PECSII and paravertebral blocks

Paravertebral nerve block

ACTIVE COMPARATOR

Ultrasound-guided paravertebral block with ropivacaine 0.75% 20 ml at T1-T2 and T3-T4 levels (10 ml each) (patients N = 75)

Procedure: PECSII and paravertebral blocks

Interventions

PECSII and paravertebral blocksPROCEDURE

Regional anesthesia for mastectomy outcomes

Paravertebral nerve blockpectoral PECS II block

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for radical mastectomy for cancer.
  • age \> 18 y-o
  • Written informed consent

You may not qualify if:

  • Bilateral surgery
  • Opioids user
  • BMI \> 35
  • Postoperative Intensive care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AUSL IRCCS Reggio Emilia

Reggio Emilia, 42120, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • gianluca cappelleri, MD

    AUSL IRCCS Reggio Emilia, Italy

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 7, 2019

Study Start

May 29, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)