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NCT Number: NCT07603271

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

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

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Key information

Conditions

Chronic Pain, Postoperative Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Sternotomy Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Neuropathic Pain Questionnaire Interview (DN4i)

    Time frame: 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 outcomes

  1. Numeric Rating Scale (NRS)

    Time frame: 3 and 6 months

    Pain intensity was assessed using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain).

  2. Neuropathic Pain Questionnaire Interview (DN4i)

    Time frame: 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. 5-level EQ-5D (EQ-5D-5L)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Marc F. LOPEZ, MD

CONTACT

[email protected]

+33492273991

Sponsors and collaborators

Lead sponsor

Institute Arnault Tzanck, France

Other

Registry information

Official study title

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

Acronym: DEPDN4i

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 2026

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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