Orthopedic DisorderALGOBASESNCT04546594
Epidemiological Data on Pain
An observational study of Orthopedic Disorder and Thoracic, run by University Hospital, Lille.
Trial summary
The ALGOBASES project is an observational epidemiological study of pain through the collection of pain evaluation questionnaires and information with the aim of creating a descriptive "pain" evaluation in all patients who need to benefit from orthopedic, thoracic or gynecological surgery. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Orthopedic Disorder, Thoracic, Gynecological; Surgery (Previous), Causing Obstructed Labor, Affecting Fetus
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Dec 2025
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients consulting at the university hospital of Lille and needing orthopedic, thoracic, gynecological surgical management with or without painful symptoms and chronic painful patients in the context of organ pathologies.
Who may be able to join
- Patient over 17 years old Patient needing orthopedic surgery Patient needing gynecological surgery Patient needing thoracic surgery Patient who has given written consent to participate in the trial. Socially insured patient Patient willing to comply with all study procedures and study duration
Who cannot join
- Age under 18 years old
- Non-communicating patient
- Patient does not understand French
- Patient without social protection
- Patient refusing to participate
About this study
Official title: Collection of Epidemiological Data on Pain Related to Orthopedic, Thoracic or Gynecological Surgery
The ALGOBASES project is an observational epidemiological study of pain through the collection of pain evaluation questionnaires and information with the aim of creating a descriptive "pain" evaluation in all patients who need to benefit from orthopedic, thoracic or gynecological surgery. The painful symptomatology will thus be evaluated in all its dimensions (demographic data, physical, psychological, socio-cultural components) and linked to the pathology justifying the specialized care. It is planned to collect the same data at each subsequent event in order to allow the determination of predictive factors, pain trajectories according to the type of surgery, and the profile of subjects at risk of acute or chronic postoperative pain.
- Conditions
- Orthopedic Disorder, Thoracic, Gynecological; Surgery (Previous), Causing Obstructed Labor, Affecting Fetus, Pain
- Keywords
- Pain,, perioperative pain, epidemiology, predictive factors
- Medical subject headings
- Musculoskeletal Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Orthopedic surgery | Not described | |
| Thoracic surgery | Not described | |
| Gynecological surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive analysis of the typology of pain in patients needing surgery.
The typology of pain will be analyzed on the basis of responses to questionnaires on the affective and sensory dimension of pain, quality of life, depression, anxiety and catastrophizing
Measured: Baseline
Secondary outcomes (5)
Descriptive analysis of specific symptomatology of pain Description of the general and painful symptomatology in patients needing surgery.
Describe the specific symptomatology of pain separately according to the 3 pathologies: patients needing orthopedic, thoracic and gynecological surgery.
Measured: follow-up over a period of five years during post-operative or pain medical consultation
Pain Catastrophizing Scale (PCS) according to pain
Measured: Baseline and follow-up over a period of five years during post-operative or pain medical consultation
Hospital Anxiety Depression scale (HAD) according to pain
Measured: Baseline and follow-up over a period of five years during post-operative or pain medical consultation
EQD5 according to pain
Measured: Baseline and follow-up over a period of five years during post-operative or pain medical consultation
Identification of factors predictive of acute or chronic pain.
The presence of pain will be defined by the presence of severe pain and/or the presence of neuropathic pain.
Measured: Baseline and at three months, six months, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study startOct 2020 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: LACK OF RESOURCES
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel Wattier, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546594
- Sponsor's protocol ID
- RNI_2018_76
- Other IDs
- 2020-A01112-37
- Acronym
- ALGOBASES
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2020
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Epidemiological Data on Pain Related to Orthopedic, Thoracic or Gynecological Surgery
- ClinicalTrials.gov ID
- NCT04546594
- Acronym / sponsor ID
- ALGOBASES / RNI_2018_76
- Conditions
- Orthopedic Disorder, Thoracic, Gynecological; Surgery (Previous), Causing Obstructed Labor, Affecting Fetus, Pain
- Keywords
- Pain,, perioperative pain, epidemiology, predictive factors
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: LACK OF RESOURCES
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Sep 2020 (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.
The ALGOBASES project is an observational epidemiological study of pain through the collection of pain evaluation questionnaires and information with the aim of creating a descriptive "pain" evaluation in all patients who need to benefit from orthopedic, thoracic or gynecological surgery. The painful symptomatology will thus be evaluated in all its dimensions (demographic data, physical, psychological, socio-cultural components) and linked to the pathology justifying the specialized care. It is planned to collect the same data at each subsequent event in order to allow the determination of predictive factors, pain trajectories according to the type of surgery, and the profile of subjects at risk of acute or chronic postoperative pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Orthopedic surgery | – | – |
| Thoracic surgery | – | – |
| Gynecological surgery | – | – |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients consulting at the university hospital of Lille and needing orthopedic, thoracic, gynecological surgical management with or without painful symptoms and chronic painful patients in the context of organ pathologies.
Key inclusion criteria (1 listed)
- Patient over 17 years old Patient needing orthopedic surgery Patient needing gynecological surgery Patient needing thoracic surgery Patient who has given written consent to participate in the trial. Socially insured patient Patient willing to comply with all study procedures and study duration
Key exclusion criteria (5 listed)
- Age under 18 years old
- Non-communicating patient
- Patient does not understand French
- Patient without social protection
- Patient refusing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Descriptive analysis of the typology of pain in patients needing surgery.
Time frame: Baseline
The typology of pain will be analyzed on the basis of responses to questionnaires on the affective and sensory dimension of pain, quality of life, depression, anxiety and catastrophizing
5 secondary outcomes
Descriptive analysis of specific symptomatology of pain Description of the general and painful symptomatology in patients needing surgery.
Time frame: follow-up over a period of five years during post-operative or pain medical consultation
Pain Catastrophizing Scale (PCS) according to pain
Time frame: Baseline and follow-up over a period of five years during post-operative or pain medical consultation
Hospital Anxiety Depression scale (HAD) according to pain
Time frame: Baseline and follow-up over a period of five years during post-operative or pain medical consultation
EQD5 according to pain
Time frame: Baseline and follow-up over a period of five years during post-operative or pain medical consultation
Identification of factors predictive of acute or chronic pain.
Time frame: Baseline and at three months, six months, one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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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.
Jean-Michel Wattier, MD principal investigator
University Hospital, Lille
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder and Thoracic, run by University Hospital, Lille.
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 1 inclusion and 5 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: withdrawn, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Descriptive analysis of the typology of pain in patients needing surgery. (time frame: Baseline). 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 23 Dec 2025.