Observational Study of an Automatic Detection of Patients... | NCT03164954

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

NCT03164954

Sponsor

Benno Rehberg-Klug

Status

Terminated

Last Update Posted

Oct 11, 2021Actual

Enrollment

355Actual

Phase

Not provided

Conditions

Pain, Postoperative

Interventions

automatic risk detection

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no recruitement possible for >12 months due to highly reduced surgical activity because of the COVID pandemic, all elective surgery was transferred to private hospitals for several months

Expanded Access Info

Start Date

Jul 1, 2017Actual

Primary Completion Date

Nov 1, 2020Actual

Completion Date

Jun 1, 2021Actual

First Submitted Date

May 22, 2017

First Submission Date that Met QC Criteria

May 22, 2017

First Posted Date

May 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2021

Last Update Posted Date

Oct 11, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Benno Rehberg-Klug, médecin adjoint agrégé, University Hospital, GenevaSponsor-Investigator

Lead Sponsor

Benno Rehberg-KlugOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

355Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

elective surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ali Bourezg, MD	University Hospital, Geneva	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpitaux Universitaires de Genève		Geneva			Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

part of the data will be entered into the international Pain-Out database

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided