Early Screening of Chronic Post-sternotomy Pain Using the DN4-i Questionnaire

Association Between Early Neuropathic Pain and Chronic Post-Sternotomy Pain After Coronary Artery Bypass Grafting (CABG): A Prospective Observational Study

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07603271

Acronym

DEPDN4i

Enrollment

120

Registered

2026-05-22

Start date

2026-05-03

Completion date

2027-11-03

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Postoperative, Sternotomy Pain

Keywords

Early and chronic neuropathic pain

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Neuropathic Pain Questionnaire Interview (DN4i)	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.

Secondary

Measure	Time frame	Description
Numeric Rating Scale (NRS)	3 and 6 months	Pain intensity was assessed using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain).
Neuropathic Pain Questionnaire Interview (DN4i)	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.
5-level EQ-5D (EQ-5D-5L)	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).

Countries

France

Contacts

CONTACTMarc F. LOPEZ, MD

ma.lopez@tzanck.org+33492273991

Outcome results