NCT03754816

Brief Summary

The combination of PECS II and parasternal Block provides analgesia after radical mastectomy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2018

Shorter than P25 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

First Submitted

Initial submission to the registry

November 25, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2019

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

November 25, 2018

Last Update Submit

April 17, 2019

Conditions

Breast Cancer

Keywords

PECS II block, parasternal block, analgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain: Numeric Rate Scale

    Postoperative pain evaluated with Numeric Rate Scale, from 0 (no pain) to 10 (worst pain)

    24 hours after surgery

Secondary Outcomes (3)

  • Intraoperative opiates

    From start to the end of surgery

  • Postoperative opiates

    24 hours after surgery

  • Side effects

    24 hours after surgery

Study Arms (1)

Experimental group

EXPERIMENTAL

The combination of PECS II and parasternal block performed by injecting Levobupivacaine 0.375% 40 ml, injected between minor and major pectoralis muscles, between minor and serratus muscles and between major and intercostal muscles

Procedure: PECS II and parasternal blockDrug: Levobupivacaine

Interventions

PECS II and parasternal blockPROCEDURE

10 ml of Levobupivacaine 0.375% injected between minor and major pectoralis muscles. 20 ml of Levobupivacaine 0.375% injected between minor and serratus muscles. 10 ml of Levobupivacaine 0.375% injected between major and intercostal muscles at II and IV intercostal space.

Also known as: Pectoral nerve block II type and parasternal block
Experimental group
LevobupivacaineDRUG

Levobupivacaine

Also known as: Locali anesthetic
Experimental group

Eligibility Criteria

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

You may qualify if:

  • ASA status patients:1,2 and 3
  • patients undergoing to radical mastectomy with axillary dissection and breast-implant reconstruction

You may not qualify if:

  • patients with allergy to local anesthetics
  • ASA status patients: 4
  • breast anatomy abnormalities
  • neurological diseases
  • septic conditions
  • coagulopathies
  • drug abuse history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Salvatore Academic Hospital

Coppito, L'Aquila, 67100, Italy

Location

MeSH Terms

Conditions

Breast NeoplasmsAgnosia

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Emiliano Petrucci

    San Salvatore Academic Hospital of L'Aquila

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 25, 2018

First Posted

November 27, 2018

Study Start

December 1, 2018

Primary Completion

March 31, 2019

Study Completion

April 12, 2019

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)