PABLOS 2.0 - Chronic Pain After Sternotomy, Prospective Non-interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- Effectiveness of LRA
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who participated in the PABLOS study (See below);
- •French-speaking patient, able to understand and answer a questionnary
排除标准
- •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.
结局指标
主要结局
Effectiveness of LRA
时间窗: 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
次要结局
- LRA Impact on the prevalence of neuropathic pain(12 to 24 months)
- LRA Impact on daily consumption of analgesics(12 to 24 months)
- To describe all-cause mortality in cardiac surgery patients(12 to 24 months)
- Infection of the puncture point(s) event in context of LRA in the long term.(12 to 24 months)
- sternotomy scar revision in context of LRA in the long term.(12 to 24 months)
- LRA Impact on quality of life(12 to 24 months)
- LRA Impact on the intensity of exercise pain(12 to 24 months)