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.
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.
Study Type
OBSERVATIONAL
Enrollment
253
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.
Dr Achille DEMARQUETTE
Angers, Maine Et Loire, France
RECRUITINGEffectiveness 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
Time frame: 12 to 24 months
LRA Impact on the intensity of exercise pain
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)
Time frame: 12 to 24 months
LRA Impact on the prevalence of neuropathic pain
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.
Time frame: 12 to 24 months
LRA Impact on daily consumption of analgesics
Evaluate by measurement of daily consumption of painkillers
Time frame: 12 to 24 months
LRA Impact on quality of life
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.
Time frame: 12 to 24 months
To describe all-cause mortality in cardiac surgery patients
Measurement of prevalence of deaths since the end of PABLOS follow-up
Time frame: 12 to 24 months
Infection of the puncture point(s) event in context of LRA in the long term.
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).
Time frame: 12 to 24 months
sternotomy scar revision in context of LRA in the long term.
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).
Time frame: 12 to 24 months
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