PABLOS 2.0 - Chronic Pain After Sternotomy

NCT06534775 | Recruiting

• 1 other identifier: 49RC24_0179
• Study Type: observational
• Target: 253
• Locations: 1 country
• Sites: 1

Brief Summary

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

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Effectiveness of LRA

  The main objective is to compare the effectiveness of LRA (bilateral transverse thoracic block or bilateral parasternal block) compared to standard management (general anesthesia without LRA) on late postoperative recovery after surgery heart by sternotomy. The main endpoint is defined by the presence at the time of the call of pain that has been evolving for \> 3 months with a numerical scale \>0. Self-assessment by numerical scale varies from 0 to 10 : * 0 being no pain * from 1 to 3 : mild pain * from 4 to 6 : moderate pain * from 7 to 10 : severe pain

  12 to 24 months

Secondary Outcomes (7)

• LRA Impact on the intensity of exercise pain

  12 to 24 months

• LRA Impact on the prevalence of neuropathic pain

  12 to 24 months

• LRA Impact on daily consumption of analgesics

  12 to 24 months

• LRA Impact on quality of life

  12 to 24 months

• To describe all-cause mortality in cardiac surgery patients

  12 to 24 months

Interventions

Questionnary OTHER

The patients were included in a previous study (PABLOS) - These patients received locoregional anesthesia (LRA) by deep parasternal intercostal block (Deep-PIP) or bilateral superficial parasternal intercostal block (Superficial-PIP), compared with standard management (general anesthesia without LRA) for chronic postoperative pain after cardiac surgery by sternotomy. In PABLOS 2.0 study, the evaluation focuses on the presence of chronic pain between 12 and 24 months postoperatively. There is no intervention in PABLOS 2.0 study but only a questionnary.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the PABLOS study, without non-inclusion criteria, are pre-selected to participate in the study. These are patients from the original PABLOS study who underwent thoracic surgery by sternotomy at the Angers University Hospital. The PABLOS inclusion period extended from August 1, 2022 to August 2, 2023. Patients receive an information letter at home, containing all the information relating to the PABLOS 2.0 study, a few weeks before receiving a telephone call, as well as a booklet containing the questionnary. From this stage, the patient has the possibility of contacting the team to express their opposition to participating in the study.

You may qualify if:

• Patient who participated in the PABLOS study (See below);
• French-speaking patient, able to understand and answer a questionnary

You may not qualify if:

• Patient opposing the research.
• PABLOS criteria (NCT05345639) :
• Adult patient (≥18 years old);
• Patient having planned cardiac surgery with performance of a sternotomy at the Angers University Hospital;
• Patient having signed consent;
• French-speaking patient, able to understand and answer a questionnary;
• Patient affiliated to or beneficiary of a social security scheme;
• Hemodynamic stability at the end of surgical intervention;
• Absence of bleeding justifying immediate surgical revision
• Known hypersensitivity to local anesthetics with amide bonds;
• Operation for cardiac surgical revision, including REDUX (surgical revision) of sternotomy;
• Emergency surgery;
• Surgery in a septic context (Endocarditis, Intravascular device infection);
• Weight less than 30kg;
• Severe psychiatric or cognitive disorder hindering assessment by questionnary;

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Dr Achille DEMARQUETTE

Angers, Maine Et Loire, 49933, France

RECRUITING

Central Study Contacts

Achille DEMARQUETTE, Dr

CONTACT

6 58 08 92 74; achille.demarquette@chu-angers.fr

Maxime LEGER, Dr

CONTACT

2 41 34 00 83; Maxime.Leger@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 2, 2024
• Study Start: August 19, 2024
• Primary Completion: August 18, 2025
• Study Completion: August 18, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

FR (1)