NCT03023007

Brief Summary

A non-randomized, mono-centric, prospective interventional study that will assess the efficacy of the loco-regional anesthesia PECS on the rate of chronic pain, 6 month after a patient will have either received a mastectomy or a mastectomy associated with axillary nodes dissection, and/or a reconstruction by prosthesis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

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

January 10, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

April 3, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2019

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

January 10, 2017

Last Update Submit

March 16, 2026

Conditions

BreastcancerMastectomy

Outcome Measures

Primary Outcomes (1)

  • Rate of chronic pain

    The rate of chronic pain will be assessed in percentage (%) based on the criteria of the International Association for the Study Pain (IASP) during an algology medical consultation.

    6 month after surgery

Secondary Outcomes (9)

  • Acute post-operative pain

    During the 3 days following the surgery

  • Side effects post-operative

    During the 3 days following the surgery

  • Rate of chronic pain

    12 month after the surgery

  • Type of chronic pain

    6 and 12 month after surgery

  • Intensity of chronic pain

    6 and 12 month after surgery

  • +4 more secondary outcomes

Other Outcomes (1)

  • Prediction of the post-operative chronic pain with Kalkman score

    within the 15 days before the surgery

Study Arms (1)

Loco-regional anaesthesia

EXPERIMENTAL

Loco-regional anaesthesia Anesthesia technique used : loco-regional PECS for patients requiring Mastectomy; And/or Axillary node dissection ; And/or Reconstruction of breast by prosthesis

Procedure: Loco-regional anaesthesia

Interventions

Loco-regional anaesthesiaPROCEDURE

Loco-regional anaesthesia

Loco-regional anaesthesia

Eligibility Criteria

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

You may qualify if:

  • Patients with unilateral breast cancer
  • Surgery must be a total mastectomy +/- axillary lymph node dissection and +/- reconstruction by prosthesis; unless first surgery was performed more than 5 years prior to total mastectomy without any residual pain
  • Age ≥ 18 ans
  • Non-opposition of patients

You may not qualify if:

  • Reconstruction by other than prosthesis
  • Previous breast surgery in the last year
  • Hypersensitivity or allergy of anaesthetics
  • Coagulopathy and local infections
  • Pregnant or breastfeeding
  • Patients under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

Related Publications (1)

  • Garcia V, Wallet J, Leroux-Bromberg N, Delbrouck D, Hannebicque K, Ben Oune F, Leguillette C, Le Deley MC, Ahmeidi A. Incidence and characteristics of chronic postsurgical pain at 6 months after total mastectomy under pectoserratus and interpectoral plane block combined with general anesthesia: a prospective cohort study. Reg Anesth Pain Med. 2024 Jan 11;49(1):36-40. doi: 10.1136/rapm-2022-104185.

    PMID: 37280082DERIVED

Study Officials

  • Abesse AHMEIDI, MD

    Département Anesthésie /Algologie, Centre Oscar Lambret

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 18, 2017

Study Start

April 3, 2017

Primary Completion

February 22, 2019

Study Completion

August 27, 2019

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)