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

NCT03164954 | Terminated

• 1 other identifier: ALDO
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• CPSP at 6 months

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

  6 months

Secondary Outcomes (6)

• CPSP at 12 months

  12 months

• clinically significant pain at 6/12 months

  6/12 months

• neuropathic pain at 6/12 months

  6/12 months

• acute postoperative pain

  24h postoperative

• pain-related functional deficit at 6/12 months

  6/12 months

Interventions

automatic risk detection DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

elective surgery

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Benno Rehberg-Klug: lead

Study Sites (1)

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ali Bourezg, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: médecin adjoint agrégé

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 24, 2017
• Study Start: July 1, 2017
• Primary Completion: November 1, 2020
• Study Completion: June 1, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-10

Locations

CH (1)