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NCT Number: NCT06534775

PABLOS 2.0 - Chronic Pain After Sternotomy

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

PABLOS 2.0 is a non-interventional cohort study with prospective data collection by telephone questionnary, with three groups from a single-center superiority interventional study. Patients remained blinded for the duration of the study.

The patients in the cohort come from the precedent PABLOS study (NCT05345639). They receive oral and written information, and confirm orally their non-opposition to participating in the PABLOS 2.0 study.

The specific procedures of the PABLOS 2.0 study are the collection using a telephone questionnary of the score of the numerical scale (from 0 to 10) of pain at rest and with effort, of the DN4 (proportion of chronic pain with a neuropathic component), of the EQ-5D-5L scale (quality of life) and of consumption of painkillers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient who has had an operation for cardiac or thoracic surgery, including a REDUX (surgical revision) of sternotomy since their inclusion in the PABLOS study;
  • Patient opposing the research.

PABLOS criteria (NCT05345639) :

Pre-inclusion criteria

  • 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;

Criteria for confirming inclusion

  • Hemodynamic stability at the end of surgical intervention;
  • Absence of bleeding justifying immediate surgical revision

Non-inclusion criteria

  • 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;
  • Pregnant, breastfeeding or parturient woman;
  • Person deprived of liberty by judicial or administrative decision;
  • Person subject to psychiatric care under duress;
  • Person subject to a legal protection measure;
  • Inclusion in another interventional study modifying post-operative pain management.

Treatment and study plan

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.

Primary outcomes

  1. Effectiveness of LRA

    Time frame: 12 to 24 months

    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

Secondary outcomes

  1. LRA Impact on the intensity of exercise pain

    Time frame: 12 to 24 months

    Exercise-induced pain self-assessed using a numerical scale ranging : 0, no pain, to 10, the maximum pain imaginable.(12 to 24 months depending on the date the interview was carried out) Pain location is taken into account : main location of the pain in predefined areas (back, head, thorax, saphenous harvest scar, abdomen)

  2. LRA Impact on the prevalence of neuropathic pain

    Time frame: 12 to 24 months

    Evaluate by the DN4 questionnary assessement. The patient must answer 10 questions divided into 4 items. If the patient's score is equal to or higher than 4/10, the test is positive.

  3. LRA Impact on daily consumption of analgesics

    Time frame: 12 to 24 months

    Evaluate by measurement of daily consumption of painkillers

  4. LRA Impact on quality of life

    Time frame: 12 to 24 months

    Quality of life measured using the EQ-5D-5L score.

    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression Each dimension have five response levels: no problems (score 1), slight problems, moderate problems, severe problems and extreme problems (score 5).

    Higher scores mean a worse outcome

    Responses are coded as single-digit numbers expressing the severity level selected in each dimension.

  5. To describe all-cause mortality in cardiac surgery patients

    Time frame: 12 to 24 months

    Measurement of prevalence of deaths since the end of PABLOS follow-up

  6. Infection of the puncture point(s) event in context of LRA in the long term.

    Time frame: 12 to 24 months

    During the telephone call, investigator will ask the patient if he/she has had an infection of the puncture site(s) after the initial PABLOS follow-up period (i.e. after 30 days post-operatively).

  7. sternotomy scar revision in context of LRA in the long term.

    Time frame: 12 to 24 months

    During the telephone call, investigator will ask the patient if he/she has the need for sternotomy scar revision after the initial PABLOS follow-up period (i.e. after 30 days post-operatively).

Study contacts

Contact information is provided by the study sponsor or research team.

Achille DEMARQUETTE, Dr

CONTACT

[email protected]

6 58 08 92 74 ext. 33

Maxime LEGER, Dr

CONTACT

[email protected]

2 41 34 00 83 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

PABLOS 2.0 - Chronic Pain After Sternotomy, Prospective Non-interventional Study

Acronym: PABLOS2

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 2, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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