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

NCT07603271 | Not Yet Recruiting

• 1 other identifier: 2026-A00419-42
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Pain, Postoperative; Sternotomy Pain

Keywords

Early and chronic neuropathic pain

Outcome Measures

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.

  Day 5

Secondary Outcomes (3)

• Numeric Rating Scale (NRS)

  3 and 6 months

• Neuropathic Pain Questionnaire Interview (DN4i)

  3 and 6 month

• 5-level EQ-5D (EQ-5D-5L)

  3 months and 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute Arnault Tzanck, France: lead

Study Sites (1)

Institut Arnault Tzanck

Saint-Laurent-du-Var, France, 06700, France

Location

Related Publications (8)

• 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.

  PMID: 31149930 BACKGROUND

• 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.

  PMID: 15733628 BACKGROUND

• 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.

  PMID: 28937533 BACKGROUND

• 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.

  PMID: 23273105 BACKGROUND

• 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.

  PMID: 28437260 BACKGROUND

• 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.

  PMID: 24566643 BACKGROUND

• 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.

  PMID: 38414426 BACKGROUND

• 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.

  PMID: 30983589 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Marc F. LOPEZ, MD

CONTACT

+33492273991; ma.lopez@tzanck.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 22, 2026
• Study Start: May 3, 2026
• Primary Completion (Estimated): May 3, 2027
• Study Completion (Estimated): November 3, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

FR (1)