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Clinical Trials/NCT03164954
NCT03164954
Terminated
Not Applicable

Étude Observationnelle Prospective d'Une Alerte Douleur informatisée Automatique Par Les Applications Informatiques hospitalières Des HUG Pour prédire l'Apparition de Douleurs Chroniques Post opératoires

Benno Rehberg-Klug1 site in 1 country355 target enrollmentJuly 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Benno Rehberg-Klug
Enrollment
355
Locations
1
Primary Endpoint
CPSP at 6 months
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

Following surgery, some but not all patients develop persistent (or chronic) postoperative pain CPSP. Several risk factors for this persistent pain have been confirmed in previous studies, but neither surgeons nor anesthesiologists have or take the time to systematically screen patients for this risk. However, hospital information systems often contain the data already, entered during preoperative consultations (e.g. chronic opioid medication) or obtained during the postoperative period (e.g. pain scores).

Here the investigators test an automatic detection algorithm which alerts the analgesia team when a patient at risk of CPSP is or has been operated.

Detailed Description

The primary aim of the study is to confirm that the sensitivity of the automatic alert is at least 80%, i.e. that 80% of patients with the primary outcome had an automatic alert. The secondary aim of the study is to develop an algorithm (combination of risk factors) with which the specificity of the alert can be improved.

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
June 1, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Benno Rehberg-Klug
Responsible Party
Sponsor Investigator
Principal Investigator

Benno Rehberg-Klug

médecin adjoint agrégé

University Hospital, Geneva

Eligibility Criteria

Inclusion Criteria

  • 18 years of age
  • elective surgery
  • perioperative use of the hospital information system
  • surgery of the following types: endoprosthesis of the knee or shoulder, amputation other than toe or finger, spinal surgery, cardio-thoracic thoracotomy, laparotomy, inguinal hernia repair, breast surgery

Exclusion Criteria

  • inability to read and understand the consent form or the questionnaires
  • emergency surgery
  • having already participated in the study for another surgery

Outcomes

Primary Outcomes

CPSP at 6 months

Time Frame: 6 months

mean pain intensity in the "brief pain inventory" of at least 3/10

Secondary Outcomes

  • clinically significant pain at 6/12 months(6/12 months)
  • acute postoperative pain(24h postoperative)
  • CPSP at 12 months(12 months)
  • neuropathic pain at 6/12 months(6/12 months)
  • pain-related functional deficit at 6/12 months(6/12 months)
  • persistent opioid use(6/12 months)

Study Sites (1)

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