Actively Recruiting

Age: 18Years +
All Genders
NCT06534775

PABLOS 2.0 - Chronic Pain After Sternotomy

Led by University Hospital, Angers · Updated on 2024-08-26

253

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The PABLOS study (NCT05345639) recently realised at the University Hospital of Angers looked at the place of loco-regional anesthesia (LRA) in the optimization of analgesia and the early post-operative recovery of patients operated from cardiac surgery by sternotomy. All randomized patients (n=253) were followed for 30 days as part of PABLOS monitoring with the aim of optimizing acute care. However, sternotomy surgery causes chronic pain with neuropathic components. Indeed, numerous recent studies suggest that cardiac surgery by median sternotomy is associated with the development of chronic sternal pain with an incidence of 11% to 56% one year after surgery. Most patients with chronic post-sternotomies pain report mild pain (1 to 3 on the Numerical Scale), however, up to 18% report moderate to severe pain (4 to 10 on the EN). It therefore seems important to the investigator to evaluate the prevalence of chronic post-sternotomies pain within our PABLOS cohort and to know whether performing a post-operative LRA limits their occurrence.

CONDITIONS

Official Title

PABLOS 2.0 - Chronic Pain After Sternotomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient who participated in the PABLOS study
  • French-speaking patient, able to understand and answer a questionnaire
  • Adult patient (18 years or older)
  • Patient having planned cardiac surgery with sternotomy at Angers University Hospital
  • Patient having signed consent
  • Patient affiliated with or beneficiary of a social security scheme
  • Hemodynamic stability at the end of surgical intervention
  • Absence of bleeding requiring immediate surgical revision
Not Eligible

You will not qualify if you...

  • Patient who has had cardiac or thoracic surgery, including surgical revision of sternotomy, since participating in the PABLOS study
  • Patient opposing the research
  • Known hypersensitivity to local anesthetics with amide bonds
  • Emergency surgery
  • Surgery in a septic context such as endocarditis or intravascular device infection
  • Weight less than 30 kg
  • Severe psychiatric or cognitive disorder preventing assessment by questionnaire
  • Pregnant, breastfeeding, or parturient women
  • Person deprived of liberty by judicial or administrative decision
  • Person under psychiatric care without consent
  • Person under legal protection
  • Participation in another interventional study affecting post-operative pain management

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Dr Achille DEMARQUETTE

Angers, Maine Et Loire, France, 49933

Actively Recruiting

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Research Team

A

Achille DEMARQUETTE, Dr

CONTACT

M

Maxime LEGER, Dr

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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