Dr Achille DEMARQUETTE
Angers, Maine Et Loire, 49933, France
Location status: Recruiting
Location contact
Achille DEMARQUETTE, Dr
CONTACT
(0)2 41 35 39 51 ext. 33
Maxime LEGER, Dr
CONTACT
(0)2 41 34 00 83 ext. 33
NCT Number: NCT06534775
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Angers, Maine Et Loire, 49933, France
Location status: Recruiting
Achille DEMARQUETTE, Dr
CONTACT
(0)2 41 35 39 51 ext. 33
Maxime LEGER, Dr
CONTACT
(0)2 41 34 00 83 ext. 33
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PABLOS criteria (NCT05345639) :
Pre-inclusion criteria
Criteria for confirming inclusion
Non-inclusion criteria
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.
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 :
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)
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.
Time frame: 12 to 24 months
Evaluate by measurement of daily consumption of painkillers
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.
Time frame: 12 to 24 months
Measurement of prevalence of deaths since the end of PABLOS follow-up
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).
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).
Contact information is provided by the study sponsor or research team.
Achille DEMARQUETTE, Dr
CONTACT
6 58 08 92 74 ext. 33
Maxime LEGER, Dr
CONTACT
2 41 34 00 83 ext. 33
University Hospital, Angers
Other Gov
PABLOS 2.0 - Chronic Pain After Sternotomy, Prospective Non-interventional Study
Acronym: PABLOS2
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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