Early Screening of Chronic Post-sternotomy Pain Using the DN4-i Questionnaire
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitute Arnault Tzanck, France
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
History of sternotomy
Early reoperation < 30 days
Chronic treatment with strong opioids or neuropahtic pain medications
Severe cognitive impairment
Trial population
Any adult patient undergoing scheduled cardiac surgery with coronary artery bypass via median sternotomy with internal mammary artery harvesting in Institut Arnault Tzanck Hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Neuropathic Pain Questionnaire Interview (DN4i)
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.
Time frame
Day 5Secondary outcomes
1
Numeric Rating Scale (NRS)
Pain intensity was assessed using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain).
Time frame
3 and 6 months2
Neuropathic Pain Questionnaire Interview (DN4i)
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.
Time frame
3 and 6 month3
5-level EQ-5D (EQ-5D-5L)
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).
Time frame
3 months and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
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