Sternotomy Closure,Open Heart SurgeryPredict-ALGOCANCT06681272
Prediction of Chronic Pain in Cardiac Surgery: Evaluation by Algocartography Predict-ALGOCARTE
An observational study of Sternotomy Closure,Open Heart Surgery and Cardiac Surgery, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Sternotomy results in chronic postoperative pain in 30-55% of subjects. Few studies have been published on chronic pain in cardiac surgery, but there appears to be a relationship between the area of peri-scar hyperalgesia, which is indicative of postoperative hyperalgesia, and the occurrence of persistent pain 6… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sternotomy Closure,Open Heart Surgery, Cardiac Surgery, Chronic Pain Post-Procedural
- What is being tested?
- Questionnaire
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2024to 27 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: This study focuses on adult patients undergoing scheduled cardiac surgery via sternotomy. 84 patients required for the study Only patients operated at Hopital Louis Pradel will be included
Who may be able to join
- Scheduled surgery
- Conventional cardiac surgery by sternotomy: valve repair or replacement, coronary, thoracic aortic or combined surgery
- Age over 18
- No opposition from patient
- Patient affiliated to a social security
Who cannot join
- Emergency surgery
- Patient refusal
- Redux surgery
- Patients under guardianship
- History of drug addiction
- Preoperative opioid treatment
Show all 9Show fewer
- Morbid obesity (body mass index >30kg/m2)
- Pregnant or breast-feeding women
- Patients taking part in another clinical study likely to interfere with the results of the present study.
Trial locations and contacts
1 site in 1 country.
France1 site
Service Anesthésie réanimation Hôpital Louis Pradel, Groupement Hospitalier Est Adresse 28 av. de Doyen Lépine 69677 BRON Cedex
Bron, France, 69677
About this study
Official title: Prediction of Chronic Pain in Cardiac Surgery: Evaluation by Algocartography
Sternotomy results in chronic postoperative pain in 30-55% of subjects. Few studies have been published on chronic pain in cardiac surgery, but there appears to be a relationship between the area of peri-scar hyperalgesia, which is indicative of postoperative hyperalgesia, and the occurrence of persistent pain 6 months after surgery. The aim of this study was therefore to assess whether the area of the postoperative hyperalgesia zone predicts chronic pain at 3 months post-surgery in cardiac surgery. To define the area of hyperalgesia at Day 2, pain mapping (algocartography) will be performed in patients who have had a sternotomy in cardiac surgery, together with pain assessment using the Simple Digital Pain Scale. Von Frey filaments of different sizes will be used for mapping. At Day 90, additional quality-of-life questionnaires will be carried out to check whether chronic pain is still present. A simple numerical scale (ENS) assessment at rest and during activity, and a record of pain-relieving treatments related to the surgery will also be carried out during this call.
The investigators hypothesize that the area of the zone of hyperalgesia assessed at Day 2 predicts the occurrence of chronic pain at 3 months.
- Being tested
- Questionnaire
- Keywords
- Chronic pain prediction, cardiac surgery, algocartography, area of hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
sleep quality assessment using the PROMIS (Patient-Reported Outcomes Measurement Information System) item Bank score
QuestionnaireOther
assessment of emotional state using the Neuropathic Pain Symptom Inventory score (NPSI)
QuestionnaireOther
To assess whether pain measured by a Numercial rating scale (NRS) predicts chronic postoperative pain.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients undergoing scheduled sternotomy cardiac surgery | Cohort, cardiac surgery patients who develop chronic pain Chronic post-surgical pain is defined as pain localized to the surgical site, with no other attributable cause, that persists for more than three months after surgery and has an impact on quality of life. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate whether the area of postoperative hyperalgesia predicts chronic pain at 3 months postoperatively in cardiac surgery.
To define the zone of hyperalgesia on Day 2, pain mapping will be carried out in patients who had a sternotomy in cardiac surgery. To this end, Von Frey filaments of different calibers will be used. Depending on the filament used and the discomfort or pain felt in different areas, we can construct a pain intensity map (or algocartography). To define chronic pain, we will use the NRS (Numerical Rating Scale) to measure pain. The gold standard is the occurrence of chronic postoperative pain defined by NRS > 3
Measured: 2 days after surgery
Evaluate whether the area of postoperative hyperalgesia predicts chronic pain at 3 months postoperatively in cardiac surgery
To define the zone of hyperalgesia on Day 2, pain mapping will be carried out in patients who had a sternotomy in cardiac surgery. To this end, Von Frey filaments of different calibers will be used. Depending on the filament used and the discomfort or pain felt in different areas, we can construct a pain intensity map (or algocartography). To define chronic pain, we will use the NRS (Numerical Rating Scale) to measure pain. The gold standard is the occurrence of chronic postoperative pain defined by NRS > 3
Measured: 90 days after surgery
Secondary outcomes (9)
Assess whether pain measured by a NRS predicts chronic postoperative pain.
AUC of the ability of pain intensity assessment by NRS in the immediate postoperative period (first 48 hours) to predict the occurrence of chronic postoperative pain, and correlation test.
Measured: 48 first hours after surgery
assess whether total morphine consumption at 3 days predicts chronic postoperative pain
AUC ROC of the capacity of cumulative morphine consumption at day 3 to predict the onset of chronic postoperative pain, and correlation test
Measured: 48 hours after surgery
Evaluate the relationship between the area of the zone of hyperalgesia by mapping the second day and postoperative morphine consumption 3 days after surgery
AUC ROC of the area of hyperalgesia at day 2 (area of hyperalgesia) to predict postoperative morphine consumption and correlation test
Measured: During 48 first hours after surgery
Evaluate the area of the hyperalgesia zone by mapping 2 days after surgery to predict the use of analgesics at 3 months postoperatively
AUC ROC of hyperalgesia area capacity at day 2 (hyperalgesia area surface), to predict analgesic consumption at 3 months and correlation test.
Measured: 2 days after surgery
assess the relationship between the area of hyperalgesia by mapping 2 days after surgery and sleep quality at 3 months postoperatively.
AUC ROC of hyperalgesia area capacity at day (hyperalgesia area surface), to predict sleep quality (PROMIS item BANK scale)
Measured: 2 days after surgey
assess the relationship between the area of hyperalgesia by mapping 2 days after surgery and sleep quality at 3 months postoperatively.
AUC ROC of hyperalgesia area capacity at day (hyperalgesia area surface), to predict sleep quality (PROMIS item BANK scale)
Measured: 90 days after surgey
Evaluate the area of the zone of hyperalgesia by mapping 2days after surgery to predict neuropathic pain at 3 months postoperatively
AUC ROC of hyperalgesia area capacity at day 2 (areas of high pain intensity and hyperalgesia area surface), to predict neuropathic pain (NPSI: neuropathic pain symptom inventory) and correlation test.
Measured: 2 days after surgey
Evaluate the area of the zone of hyperalgesia by mapping 2days after surgery to predict neuropathic pain at 3 months postoperatively
AUC ROC of hyperalgesia area capacity at day 2 (areas of high pain intensity and hyperalgesia area surface), to predict neuropathic pain (NPSI: neuropathic pain symptom inventory) and correlation test
Measured: 90 days after
Assessing whether preoperative anxiety predicts chronic postoperative pain
AUC ROC of the ability of preoperative anxiety to predict the occurrence of chronic postoperative pain, and correlation test.
Measured: 1 to 2 days before surgey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start27 Nov 2024
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sternotomy Closure,Open Heart SurgeryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judit JORDANA BOFILL, PI-nurse, Principal investigator, Service d'Anesthésie Réanimation Hôpital Louis Pradel, Groupement Hospitalier Est 28 av. du Doyen Lépine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681272
- Sponsor's protocol ID
- 69HCL24_0457
- Other IDs
- 2024-A01249-38
- Acronym
- Predict-ALGOCA
- Status last verified
- Mar 2026
- First submitted
- 6 Nov 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Chronic Pain in Cardiac Surgery: Evaluation by Algocartography
- ClinicalTrials.gov ID
- NCT06681272
- Acronym / sponsor ID
- Predict-ALGOCA / 69HCL24_0457
- Keywords
- Chronic pain prediction, cardiac surgery, algocartography, area of hyperalgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 8 Nov 2024 (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.
Sternotomy results in chronic postoperative pain in 30-55% of subjects. Few studies have been published on chronic pain in cardiac surgery, but there appears to be a relationship between the area of peri-scar hyperalgesia, which is indicative of postoperative hyperalgesia, and the occurrence of persistent pain 6 months after surgery. The aim of this study was therefore to assess whether the area of the postoperative hyperalgesia zone predicts chronic pain at 3 months post-surgery in cardiac surgery. To define the area of hyperalgesia at Day 2, pain mapping (algocartography) will be performed in patients who have had a sternotomy in cardiac surgery, together with pain assessment using the Simple Digital Pain Scale. Von Frey filaments of different sizes will be used for mapping. At Day 90, additional quality-of-life questionnaires will be carried out to check whether chronic pain is still present. A simple numerical scale (ENS) assessment at rest and during activity, and a record of pain-relieving treatments related to the surgery will also be carried out during this call.
The investigators hypothesize that the area of the zone of hyperalgesia assessed at Day 2 predicts the occurrence of chronic pain at 3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients undergoing scheduled sternotomy cardiac surgery | – | Other: QuestionnaireCohort, cardiac surgery patients who develop chronic pain Chronic post-surgical pain is defined as pain localized to the surgical site, with no other attributable cause, that persists for more than three months after surgery and has an impact on quality of life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study focuses on adult patients undergoing scheduled cardiac surgery via sternotomy. 84 patients required for the study Only patients operated at Hopital Louis Pradel will be included
Key inclusion criteria (5 listed)
- Scheduled surgery
- Conventional cardiac surgery by sternotomy: valve repair or replacement, coronary, thoracic aortic or combined surgery
- Age over 18
- No opposition from patient
- Patient affiliated to a social security
Key exclusion criteria (9 listed)
- Emergency surgery
- Patient refusal
- Redux surgery
- Patients under guardianship
- History of drug addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnairesleep quality assessment using the PROMIS (Patient-Reported Outcomes Measurement Information System) item Bank score | Other | Adult patients undergoing scheduled sternotomy cardiac surgery |
| Questionnaireassessment of emotional state using the Neuropathic Pain Symptom Inventory score (NPSI) | Other | Adult patients undergoing scheduled sternotomy cardiac surgery |
| QuestionnaireTo assess whether pain measured by a Numercial rating scale (NRS) predicts chronic postoperative pain. | Other | Adult patients undergoing scheduled sternotomy cardiac surgery |
Primary outcome
Evaluate whether the area of postoperative hyperalgesia predicts chronic pain at 3 months postoperatively in cardiac surgery.
Time frame: 2 days after surgery
To define the zone of hyperalgesia on Day 2, pain mapping will be carried out in patients who had a sternotomy in cardiac surgery. To this end, Von Frey filaments of different calibers will be used. Depending on the filament used and the discomfort or pain felt in different areas, we can construct a pain intensity map (or algocartography). To define chronic pain, we will use the NRS (Numerical Rating Scale) to measure pain. The gold standard is the occurrence of chronic postoperative pain defined by NRS > 3
Evaluate whether the area of postoperative hyperalgesia predicts chronic pain at 3 months postoperatively in cardiac surgery
Time frame: 90 days after surgery
To define the zone of hyperalgesia on Day 2, pain mapping will be carried out in patients who had a sternotomy in cardiac surgery. To this end, Von Frey filaments of different calibers will be used. Depending on the filament used and the discomfort or pain felt in different areas, we can construct a pain intensity map (or algocartography). To define chronic pain, we will use the NRS (Numerical Rating Scale) to measure pain. The gold standard is the occurrence of chronic postoperative pain defined by NRS > 3
9 secondary outcomes
Assess whether pain measured by a NRS predicts chronic postoperative pain.
Time frame: 48 first hours after surgery
assess whether total morphine consumption at 3 days predicts chronic postoperative pain
Time frame: 48 hours after surgery
Evaluate the relationship between the area of the zone of hyperalgesia by mapping the second day and postoperative morphine consumption 3 days after surgery
Time frame: During 48 first hours after surgery
Evaluate the area of the hyperalgesia zone by mapping 2 days after surgery to predict the use of analgesics at 3 months postoperatively
Time frame: 2 days after surgery
assess the relationship between the area of hyperalgesia by mapping 2 days after surgery and sleep quality at 3 months postoperatively.
Time frame: 2 days after surgey
assess the relationship between the area of hyperalgesia by mapping 2 days after surgery and sleep quality at 3 months postoperatively.
Time frame: 90 days after surgey
Evaluate the area of the zone of hyperalgesia by mapping 2days after surgery to predict neuropathic pain at 3 months postoperatively
Time frame: 2 days after surgey
Evaluate the area of the zone of hyperalgesia by mapping 2days after surgery to predict neuropathic pain at 3 months postoperatively
Time frame: 90 days after
Assessing whether preoperative anxiety predicts chronic postoperative pain
Time frame: 1 to 2 days before surgey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Judit JORDANA BOFILL, PI-nurse principal investigator
Service d'Anesthésie Réanimation Hôpital Louis Pradel, Groupement Hospitalier Est 28 av. du Doyen Lépine
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 Sternotomy Closure,Open Heart Surgery and Cardiac Surgery, run by Hospices Civils de Lyon 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 12 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate whether the area of postoperative hyperalgesia predicts chronic pain at 3 months postoperatively in cardiac surgery. (time frame: 2 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2026.