PABLOS 2.0 - Chronic Pain After Sternotomy
NCT Number: NCT06534775
Acronym: PABLOS2
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anesthesia
Interventions: OTHER: Questionnary
Sponsor: University Hospital, Angers
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 253
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-19
Completion Date: 2025-08-18
Locations: Dr Achille DEMARQUETTE, Angers, Maine Et Loire, 49933, France

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.

Primary Outcome Measures: 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 Outcome Measures: 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), 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., 12 to 24 months|LRA Impact on daily consumption of analgesics, Evaluate by measurement of daily consumption of painkillers, 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., 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, 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)., 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)., 12 to 24 months