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

NCT ID: NCT03164954

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 355 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2021-06-01

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.

Conditions

Pain, Postoperative

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

automatic risk detection

automatic alert of the risk for CPSP, triggered by one of the following entries in the hospital information system: psychological risk factors (depression, anxiety, PTSD, catastrophizing, high pain anticipation), chronic use of benzodiazepines or opioids, intense postoperative pain or need of large opioid doses in the recovery room

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benno Rehberg-Klug

OTHER

Sponsor Role: lead

Responsible Party

Benno Rehberg-Klug

médecin adjoint agrégé

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ali Bourezg, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

ALDO

Identifier Type: -

Identifier Source: org_study_id