Early Screening of Chronic Post-sternotomy Pain Using the DN4-i Questionnaire (DEPDN4i)
Association Between Early Neuropathic Pain and Chronic Post-Sternotomy Pain After Coronary Artery Bypass Grafting (CABG): A Prospective Observational Study
Chronic post-sternotomy pain (CPSP) is a common complication after cardiac surgery, with a reported prevalence between 30% and 50%. Several studies show that a significant proportion of patients experience persistent pain long after cardiac surgery, often with a neuropathic component. Internal mammary artery harvesting is known to cause intercostal nerve injury. Recent data suggest that early neuropathic pain, assessed using the DN4 score, may predict the chronicization of postoperative pain.
This study is a prospective observationnal study to evaluate the association between early neuropathic pain (DN4-i ≥ 3/7 on postoperative day 5) and the occurrence of chronic post-sternotomy pain at 3 months in patients who underwent median sternotomy for coronary artery bypass grafting with internal mammary artery harvesting
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Marc F. LOPEZ, MD
- 电话号码:+33492273991
- 邮箱:ma.lopez@tzanck.org
学习地点
-
-
France
-
Saint-Laurent-du-Var、France、法国、06700
- Institut Arnault Tzanck
-
接触:
- Marc F. LOPEZ, MD
- 电话号码:+33492273991
- 邮箱:ma.lopez@tzanck.org
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Age ≥ 18 years
- Scheduled cardiac surgery with coronary artery bypass via median sternotomy with internal mammary artery harvesting
- Patients receive an information sheet and a non-opposition form.
Exclusion Criteria:
- History of sternotomy
- Early reoperation < 30 days
- Chronic treatment with strong opioids or neuropahtic pain medications
- Severe cognitive impairment
- Patients under legal protection or guardianship
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Neuropathic Pain Questionnaire Interview (DN4i)
大体时间:Day 5
|
Abbreviated DN4i questionnaire Minimal : 0 Maximal : 7 The DN4i is a validated interview-based questionnaire designed to identify neuropathic pain.
It consists of 7 sensory descriptors reported by the patient.
A score ≥ 3/7 suggests the presence of neuropathic pain.
|
Day 5
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Numeric Rating Scale (NRS)
大体时间:3 and 6 months
|
Pain intensity was assessed using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain).
|
3 and 6 months
|
|
Neuropathic Pain Questionnaire Interview (DN4i)
大体时间:3 and 6 month
|
Abbreviated DN4i questionnaire Minimal : 0 Maximal : 7 The DN4i is a validated interview-based questionnaire designed to identify neuropathic pain.
It consists of 7 sensory descriptors reported by the patient.
A score ≥ 3/7 suggests the presence of neuropathic pain.
|
3 and 6 month
|
|
5-level EQ-5D (EQ-5D-5L)
大体时间:3 months and 6 months
|
Evaluation of functionnal impact on quality of life with EQ-5D-5L The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Five items representing five dimensions: Mobility; Self-care; Usual activities; Pain and discomfort; Anxiety and depression. Responses are recorded on 5-point scales (1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: extreme problems or complete inability). |
3 months and 6 months
|
合作者和调查者
出版物和有用的链接
一般刊物
- Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lanteri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. doi: 10.1016/j.pain.2004.12.010. Epub 2005 Jan 26.
- Haroutiunian S, Nikolajsen L, Finnerup NB, Jensen TS. The neuropathic component in persistent postsurgical pain: a systematic literature review. Pain. 2013 Jan;154(1):95-102. doi: 10.1016/j.pain.2012.09.010.
- Anwar S, Cooper J, Rahman J, Sharma C, Langford R. Prolonged Perioperative Use of Pregabalin and Ketamine to Prevent Persistent Pain after Cardiac Surgery. Anesthesiology. 2019 Jul;131(1):119-131. doi: 10.1097/ALN.0000000000002751.
- Glare P, Aubrey KR, Myles PS. Transition from acute to chronic pain after surgery. Lancet. 2019 Apr 13;393(10180):1537-1546. doi: 10.1016/S0140-6736(19)30352-6.
- Kleiman AM, Sanders DT, Nemergut EC, Huffmyer JL. Chronic Poststernotomy Pain: Incidence, Risk Factors, Treatment, Prevention, and the Anesthesiologist's Role. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):698-708. doi: 10.1097/AAP.0000000000000663.
- Beloeil H, Sion B, Rousseau C, Albaladejo P, Raux M, Aubrun F, Martinez V; SFAR research network. Early postoperative neuropathic pain assessed by the DN4 score predicts an increased risk of persistent postsurgical neuropathic pain. Eur J Anaesthesiol. 2017 Oct;34(10):652-657. doi: 10.1097/EJA.0000000000000634.
- Choiniere M, Watt-Watson J, Victor JC, Baskett RJ, Bussieres JS, Carrier M, Cogan J, Costello J, Feindel C, Guertin MC, Racine M, Taillefer MC. Prevalence of and risk factors for persistent postoperative nonanginal pain after cardiac surgery: a 2-year prospective multicentre study. CMAJ. 2014 Apr 15;186(7):E213-23. doi: 10.1503/cmaj.131012. Epub 2014 Feb 24.
- Martinez V, Lehman T, Lavand'homme P, Harkouk H, Kalso E, Pogatzki-Zahn EM, Komann M, Meissner W, Weinmann C, Fletcher D. Chronic postsurgical pain: A European survey. Eur J Anaesthesiol. 2024 May 1;41(5):351-362. doi: 10.1097/EJA.0000000000001974. Epub 2024 Feb 27.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2026-A00419-42 (其他标识符:ANSM)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.