PABLOS 2.0 - Chronic Pain After Sternotomy
- Conditions
- Anesthesia
- Registration Number
- NCT06534775
- Lead Sponsor
- University Hospital, Angers
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 253
- Patient who participated in the PABLOS study (See below);
- French-speaking patient, able to understand and answer a questionnary
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness of LRA 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 Outcome Measures
Name Time Method LRA Impact on the prevalence of neuropathic pain 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.
LRA Impact on daily consumption of analgesics 12 to 24 months Evaluate by measurement of daily consumption of painkillers
To describe all-cause mortality in cardiac surgery patients 12 to 24 months Measurement of prevalence of deaths since the end of PABLOS follow-up
Infection of the puncture point(s) event in context of LRA in the long term. 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).
sternotomy scar revision in context of LRA in the long term. 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).
LRA Impact on quality of life 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.LRA Impact on the intensity of exercise pain 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)
Trial Locations
- Locations (1)
Dr Achille DEMARQUETTE
🇫🇷Angers, Maine Et Loire, France