Chronic Pain, PostoperativeDEPDN4iNCT07603271
Early Screening of Chronic Post-sternotomy Pain Using the DN4-i Questionnaire
An observational study of Chronic Pain, Postoperative and Sternotomy Pain, run by Institute Arnault Tzanck, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Postoperative, Sternotomy Pain
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2026to 3 Nov 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Institut Arnault Tzanck
Saint-Laurent-du-Var, France, 06700
Marc F. LOPEZ, MD, +33492273991, ma.lopez@tzanck.org
About this study
Official title: 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
- Conditions
- Chronic Pain, Postoperative, Sternotomy Pain
- Keywords
- Early and chronic neuropathic pain
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 5
Secondary outcomes (3)
Numeric Rating Scale (NRS)
Pain intensity was assessed using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain).
Measured: 3 and 6 months
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.
Measured: 3 and 6 month
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).
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start3 May 2026 (estimated)
- Primary completion3 May 2027 (estimated)
- Study completion3 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Institute Arnault Tzanck, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc LOPEZ, MD, Institute Arnault Tzanck, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603271
- Sponsor's protocol ID
- 2026-A00419-42
- Other IDs
- 2026-A00419-42
- Acronym
- DEPDN4i
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31149930Bouhassira 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.
PubMed 15733628Kleiman 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.
PubMed 28937533Haroutiunian 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.
PubMed 23273105Beloeil 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.
PubMed 28437260Choiniere 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.
PubMed 24566643Martinez 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.
PubMed 38414426Glare 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.
PubMed 30983589
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Early Neuropathic Pain and Chronic Post-Sternotomy Pain After Coronary Artery Bypass Grafting (CABG): A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07603271
- Acronym / sponsor ID
- DEPDN4i / 2026-A00419-42
- Conditions
- Chronic Pain, Postoperative, Sternotomy Pain
- Keywords
- Early and chronic neuropathic pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institute Arnault Tzanck, FranceUniversity, hospital or other
- Study start
- 3 May 2026 (estimated)
- Primary completion
- 3 May 2027 (estimated)
- Study completion
- 3 Nov 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Numeric Rating Scale (NRS)
Time frame: 3 and 6 months
Neuropathic Pain Questionnaire Interview (DN4i)
Time frame: 3 and 6 month
5-level EQ-5D (EQ-5D-5L)
Time frame: 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 31149930Anwar 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.
- Background: PubMed 15733628Bouhassira 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.
- Background: PubMed 28937533Kleiman 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.
- Background: PubMed 23273105Haroutiunian 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.
- Background: PubMed 28437260Beloeil 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.
- Background: PubMed 24566643Choiniere 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.
- Background: PubMed 38414426Martinez 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.
- Background: PubMed 30983589Glare 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, Postoperative and Sternotomy Pain, run by Institute Arnault Tzanck, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc F. LOPEZ, MD (+33492273991, ma.lopez@tzanck.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic Pain Questionnaire Interview (DN4i) (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07603271, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.