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

NCT06681272 | Completed

• 2 other identifiers: 69HCL24_04572024-A01249-38
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  90 days after surgery

Secondary Outcomes (9)

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

  48 first hours after surgery

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

  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

  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

  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.

  2 days after surgey

Study Arms (1)

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.

Other: Questionnaire

Interventions

Questionnaire OTHER

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

Adult patients undergoing scheduled sternotomy cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, France, 69677, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Judit JORDANA BOFILL, PI-nurse

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 8, 2024
• Study Start: November 27, 2024
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)