Pain, PostoperativeALDONCT03164954
Observational Study of an Automatic Detection of Patients at Risk of Chronic Postoperative Pain ("Alerte Douleur")
An observational study of Pain, Postoperative, run by Benno Rehberg-Klug at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- automatic risk detection
- How many people
- 355 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2017to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: elective surgery
Who may be able to join
- 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
Who cannot join
- inability to read and understand the consent form or the questionnaires
- emergency surgery
- having already participated in the study for another surgery
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- automatic risk detection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
automatic risk detectionDiagnostic 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
What is being measured
The primary outcome is the main question the study is designed to answer.
CPSP at 6 months
mean pain intensity in the "brief pain inventory" of at least 3/10
Measured: 6 months
Secondary outcomes (6)
CPSP at 12 months
mean pain intensity in the "brief pain inventory" of at least 3/10
Measured: 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
Measured: 6/12 months
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
Measured: 6/12 months
acute postoperative pain
mean pain score and highest pain score in the first 24h postoperative on a 0-10 verbal numeric rating scale
Measured: 24h postoperative
pain-related functional deficit at 6/12 months
pain interference scales of the brief pain inventory, number of days not working
Measured: 6/12 months
persistent opioid use
patient reported use of tramadol (yes/no) or use of strong opioids (yes/no)
Measured: 6/12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Jul 2017
- Primary completion1 Nov 2020
- Study completion1 Jun 2021
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benno Rehberg-Klug
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Benno Rehberg-Klug, University Hospital, Geneva
- Investigators
- Ali Bourezg, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164954
- Sponsor's protocol ID
- ALDO
- Acronym
- ALDO
- Status last verified
- Oct 2021
- First submitted
- 22 May 2017
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: part of the data will be entered into the international Pain-Out database
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03164954
- Acronym / sponsor ID
- ALDO / ALDO
- Conditions
- Pain, Postoperative
- Study type
- Observational
- Recruitment status
- TerminatedReason 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
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Benno Rehberg-KlugUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- elective surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- inability to read and understand the consent form or the questionnaires
- emergency surgery
- having already participated in the study for another surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| automatic risk detectionautomatic 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 | Diagnostic test | – |
Primary outcome
CPSP at 6 months
Time frame: 6 months
mean pain intensity in the "brief pain inventory" of at least 3/10
6 secondary outcomes
CPSP at 12 months
Time frame: 12 months
clinically significant pain at 6/12 months
Time frame: 6/12 months
neuropathic pain at 6/12 months
Time frame: 6/12 months
acute postoperative pain
Time frame: 24h postoperative
pain-related functional deficit at 6/12 months
Time frame: 6/12 months
persistent opioid use
Time frame: 6/12 months
Results and safety
The study was stopped early (reason given: 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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: Undecided. part of the data will be entered into the international Pain-Out database
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Bourezg, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Benno Rehberg-Klug at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPSP at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.