Clinical trial NCT06681272: Prediction of Chronic Pain in Cardiac Surgery: Evaluation by Algocartography Predict-ALGOCARTE
Official title: Prediction of Chronic Pain in Cardiac Surgery: Evaluation by Algocartography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sternotomy Closure,open Heart Surgery
Cardiac Surgery
Chronic Pain Post-Procedural
Keywords: Chronic pain prediction
cardiac surgery
algocartography
area of hyperalgesia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate whether the area of postoperative hyperalgesia predicts chronic pain at 3 months postoperatively in cardiac surgery.
timeFrame: 2 days after surgery
measure: Evaluate whether the area of postoperative hyperalgesia predicts chronic pain at 3 months postoperatively in cardiac surgery
timeFrame: 90 days after surgery
Secondary outcomes:
measure: Assess whether pain measured by a NRS predicts chronic postoperative pain.
timeFrame: 48 first hours after surgery
measure: assess whether total morphine consumption at 3 days predicts chronic postoperative pain
timeFrame: 48 hours after surgery
measure: Evaluate the relationship between the area of the zone of hyperalgesia by mapping the second day and postoperative morphine consumption 3 days after surgery
timeFrame: During 48 first hours after surgery
measure: Evaluate the area of the hyperalgesia zone by mapping 2 days after surgery to predict the use of analgesics at 3 months postoperatively
timeFrame: 2 days after surgery
measure: assess the relationship between the area of hyperalgesia by mapping 2 days after surgery and sleep quality at 3 months postoperatively.
timeFrame: 2 days after surgey
measure: assess the relationship between the area of hyperalgesia by mapping 2 days after surgery and sleep quality at 3 months postoperatively.
timeFrame: 90 days after surgey
measure: Evaluate the area of the zone of hyperalgesia by mapping 2days after surgery to predict neuropathic pain at 3 months postoperatively
timeFrame: 2 days after surgey
measure: Evaluate the area of the zone of hyperalgesia by mapping 2days after surgery to predict neuropathic pain at 3 months postoperatively
timeFrame: 90 days after
measure: Assessing whether preoperative anxiety predicts chronic postoperative pain
timeFrame: 1 to 2 days before surgey
Other outcomes:
Locations:
city: Bron
country: France
facility: Service Anesthésie réanimation Hôpital Louis Pradel, Groupement Hospitalier Est Adresse 28 av. de Doyen Lépine 69677 BRON Cedex
Study officials:
affiliation: Service d'Anesthésie Réanimation Hôpital Louis Pradel, Groupement Hospitalier Est 28 av. du Doyen Lépine
name: Judit JORDANA BOFILL, PI-nurse
role: PRINCIPAL_INVESTIGATOR
References: