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

Pain, Postoperative Clinical Trial

— ALDO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03164954
• Other study ID #: ALDO
• Status: Terminated
• Start date: July 1, 2017
• Est. completion date: June 1, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 355
• Est. completion date: June 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Switzerland	Hôpitaux Universitaires de Genève	Genève

Sponsors (1)

Lead Sponsor	Collaborator
Benno Rehberg-Klug

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPSP at 6 months	mean pain intensity in the "brief pain inventory" of at least 3/10	6 months
Secondary	CPSP at 12 months	mean pain intensity in the "brief pain inventory" of at least 3/10	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	pain-related functional deficit at 6/12 months	pain interference scales of the brief pain inventory, number of days not working	6/12 months
Secondary	persistent opioid use	patient reported use of tramadol (yes/no) or use of strong opioids (yes/no)	6/12 months