Observational Study of an Automatic Detection of Patients at Risk of Chronic Postoperative Pain ("Alerte Douleur") (ALDO)

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

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.

Study Overview

• Status: Terminated
• Conditions: Pain, Postoperative
• Intervention / Treatment: Diagnostic test: automatic risk detection

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.

• Study Type: Observational
• Enrollment (Actual): 355

Contacts and Locations

Study Locations

• Switzerland
  • Genève, Switzerland
    • Hôpitaux Universitaires de Genève

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

elective surgery

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPSP at 6 months	mean pain intensity in the "brief pain inventory" of at least 3/10	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPSP at 12 months	mean pain intensity in the "brief pain inventory" of at least 3/10	12 months
clinically significant pain at 6/12 months	either a pain intensity of >=3 at rest or >=5 on movement or use of analgesics	6/12 months
neuropathic pain at 6/12 months	mean pain intensity in the "brief pain inventory" of at least 3/10 AND a DN4 score of at least 4	6/12 months
acute postoperative pain	mean pain score and highest pain score in the first 24h postoperative on a 0-10 verbal numeric rating scale	24h postoperative
pain-related functional deficit at 6/12 months	pain interference scales of the brief pain inventory, number of days not working	6/12 months
persistent opioid use	patient reported use of tramadol (yes/no) or use of strong opioids (yes/no)	6/12 months

Collaborators and Investigators

• Sponsor: Benno Rehberg-Klug
• Investigators: Principal Investigator: Ali Bourezg, MD, Hôpitaux Universitaires de Genève

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 11, 2021
• Last Update Submitted That Met QC Criteria: October 3, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: ALDO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: part of the data will be entered into the international Pain-Out database

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No