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

Terminated

• Conditions: Pain, Postoperative

• Registration Number: NCT03164954
• Lead Sponsor: Benno Rehberg-Klug

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.

Study Timeline

• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-22
• Study First Posted: 2017-05-24
• Study Start: 2017-07-01
• Primary Completion: 2020-11-01
• Study Completion: 2021-06-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-03
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 355

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CPSP at 6 months	6 months	mean pain intensity in the "brief pain inventory" of at least 3/10

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpitaux Universitaires de Genève; 🇨🇭 Genève, Switzerland