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NCT Number: NCT06681272

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service Anesthésie réanimation Hôpital Louis Pradel, Groupement Hospitalier Est Adresse 28 av. de Doyen Lépine 69677 BRON Cedex

Bron, France, 69677

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire

Other

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Assess whether pain measured by a NRS predicts chronic postoperative pain.

    Time frame: 48 first hours after surgery

    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.

  2. assess whether total morphine consumption at 3 days predicts chronic postoperative pain

    Time frame: 48 hours after surgery

    AUC ROC of the capacity of cumulative morphine consumption at day 3 to predict the onset of chronic postoperative pain, and correlation test

  3. 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

    AUC ROC of the area of hyperalgesia at day 2 (area of hyperalgesia) to predict postoperative morphine consumption and correlation test

  4. 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

    AUC ROC of hyperalgesia area capacity at day 2 (hyperalgesia area surface), to predict analgesic consumption at 3 months and correlation test.

  5. 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

    AUC ROC of hyperalgesia area capacity at day (hyperalgesia area surface), to predict sleep quality (PROMIS item BANK scale)

  6. 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

    AUC ROC of hyperalgesia area capacity at day (hyperalgesia area surface), to predict sleep quality (PROMIS item BANK scale)

  7. 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

    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.

  8. 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

    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

  9. Assessing whether preoperative anxiety predicts chronic postoperative pain

    Time frame: 1 to 2 days before surgey

    AUC ROC of the ability of preoperative anxiety to predict the occurrence of chronic postoperative pain, and correlation test.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Prediction of Chronic Pain in Cardiac Surgery: Evaluation by Algocartography

Acronym: Predict-ALGOCA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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