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Prediction of Chronic Pain in Cardiac Surgery: Evaluation by Algocartography Predict-ALGOCARTE

Prediction of Chronic Pain in Cardiac Surgery: Evaluation by Algocartography

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06681272
Acronym
Predict-ALGOCA
Enrollment
84
Registered
2024-11-08
Start date
2024-11-27
Completion date
2026-02-27
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Chronic Pain Post-Procedural, Sternotomy Closure,Open Heart Surgery

Keywords

Chronic pain prediction, cardiac surgery, algocartography, area of hyperalgesia

Brief 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 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.

Interventions

OTHERQuestionnaire

sleep quality assessment using the PROMIS (Patient-Reported Outcomes Measurement Information System) item Bank score

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* 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

Exclusion criteria

* Emergency surgery * Patient refusal * Redux surgery * Patients under guardianship * History of drug addiction * Preoperative opioid treatment * 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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluate whether the area of postoperative hyperalgesia predicts chronic pain at 3 months postoperatively in cardiac surgery.2 days after surgeryTo 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 surgery90 days after surgeryTo 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

Secondary

MeasureTime frameDescription
Assess whether pain measured by a NRS predicts chronic postoperative pain.48 first hours after surgeryAUC 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.
assess whether total morphine consumption at 3 days predicts chronic postoperative pain48 hours after surgeryAUC ROC of the capacity of cumulative morphine consumption at day 3 to predict the onset of chronic postoperative pain, and correlation test
Evaluate the relationship between the area of the zone of hyperalgesia by mapping the second day and postoperative morphine consumption 3 days after surgeryDuring 48 first hours after surgeryAUC ROC of the area of hyperalgesia at day 2 (area of hyperalgesia) to predict postoperative morphine consumption and correlation test
Evaluate the area of the hyperalgesia zone by mapping 2 days after surgery to predict the use of analgesics at 3 months postoperatively2 days after surgeryAUC ROC of hyperalgesia area capacity at day 2 (hyperalgesia area surface), to predict analgesic consumption at 3 months and correlation test.
assess the relationship between the area of hyperalgesia by mapping 2 days after surgery and sleep quality at 3 months postoperatively.2 days after surgeyAUC ROC of hyperalgesia area capacity at day (hyperalgesia area surface), to predict sleep quality (PROMIS item BANK scale)
Evaluate the area of the zone of hyperalgesia by mapping 2days after surgery to predict neuropathic pain at 3 months postoperatively2 days after surgeyAUC 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.
Assessing whether preoperative anxiety predicts chronic postoperative pain1 to 2 days before surgeyAUC ROC of the ability of preoperative anxiety to predict the occurrence of chronic postoperative pain, and correlation test.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJudit JORDANA BOFILL, PI-nurse

Service d'Anesthésie Réanimation Hôpital Louis Pradel, Groupement Hospitalier Est 28 av. du Doyen Lépine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026