An observational study in Sternotomy Closure,Open Heart Surgery, Cardiac Surgery and Chronic Pain Post-Procedural, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Hospices Civils de Lyon · Observational
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.
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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
Exclusion Criteria:
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.
Other: Questionnaire
sleep quality assessment using the PROMIS (Patient-Reported Outcomes Measurement Information System) item Bank score
assessment of emotional state using the Neuropathic Pain Symptom Inventory score (NPSI)
To assess whether pain measured by a Numercial rating scale (NRS) predicts chronic postoperative pain.
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
Time frame: 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
Time frame: 90 days after surgery
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.
Time frame: 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
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
AUC ROC of the area of hyperalgesia at day 2 (area of hyperalgesia) to predict postoperative morphine consumption and correlation test
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
AUC ROC of hyperalgesia area capacity at day 2 (hyperalgesia area surface), to predict analgesic consumption at 3 months and correlation test.
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.
AUC ROC of hyperalgesia area capacity at day (hyperalgesia area surface), to predict sleep quality (PROMIS item BANK scale)
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.
AUC ROC of hyperalgesia area capacity at day (hyperalgesia area surface), to predict sleep quality (PROMIS item BANK scale)
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
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.
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
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
Time frame: 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.
Time frame: 1 to 2 days before surgey
Plan to share: No
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Hospices Civils de Lyon