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

NCT ID: NCT06681272

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-27

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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Chronic pain prediction cardiac surgery algocartography area of hyperalgesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Questionnaire

Intervention Type OTHER

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

Questionnaire

Intervention Type OTHER

assessment of emotional state using the Neuropathic Pain Symptom Inventory score (NPSI)

Questionnaire

Intervention Type OTHER

To assess whether pain measured by a Numercial rating scale (NRS) predicts chronic postoperative pain.

Interventions

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Questionnaire

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

Intervention Type OTHER

Questionnaire

assessment of emotional state using the Neuropathic Pain Symptom Inventory score (NPSI)

Intervention Type OTHER

Questionnaire

To assess whether pain measured by a Numercial rating scale (NRS) predicts chronic postoperative pain.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Judit JORDANA BOFILL, PI-nurse

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Bron, France, France

Site Status

Countries

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France

Other Identifiers

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2024-A01249-38

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL24_0457

Identifier Type: -

Identifier Source: org_study_id