Surgical Procedures, OperativeETADOLNCT05326737
Evaluation of Pain Trajectories After Surgery and Their Potential Relationship With Chronicity at 3 Months
An observational study of Surgical Procedures, Operative and Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The effective management of acute postoperative pain remains a daily challenge despite the organizational efforts made and the techniques put in place. Thirty percent of patients who undergo surgery suffer from chronic post-surgical pain, of which 5 to 10% are of severe intensity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Procedures, Operative, Pain, Chronic Pain
- What is being tested?
- In hospital pain evaluation, In hospital questionnaires and Telephone contact at 3 months
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2021to 23 May 2024
- 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: The study population consists of adult surgery patients at the Nîmes University Hospital, with recruitment based on the operating theater program ffor a predefined list of surgeries.
Who may be able to join
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 3 months of follow-up
- The patient has undergone a planned surgical procedure in one of the participating departments
- The patient is willing and able to respond to the study questionnaires
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- It is impossible to correctly inform the patient
- Patient admitted to the ICU and still intubated at day 1
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
Joël L'Hermite, MD
Philippe Cuvillon, MD, PhD
About this study
Official title: Evaluation of Pain Trajectories After Surgery and Their Potential Relationship With Chronicity at 3 Months: a Single-center Prospective Cohort Study
The effective management of acute postoperative pain remains a daily challenge despite the organizational efforts made and the techniques put in place.
Thirty percent of patients who undergo surgery suffer from chronic post-surgical pain, of which 5 to 10% are of severe intensity. Many preoperative, intraoperative, and postoperative factors, related to the patient, the surgical procedure, or the anesthetic technique, have been incriminated as risk factors for chronic post-surgical pain. The severity of acute postoperative pain is recognized as one of the risk factors for the occurrence of chronic post-surgical pain on which we can hope to interact during the peri-operative period.
In this cohort study, we wish to define the typologies of postoperative pain trajectories observed from Day 0 to Day 7 and to estimate the proportion of patients with an abnormal resolution of pain in a model of organization such as that of our institution, in classic hospitalization and in ambulatory care.
- Conditions
- Surgical Procedures, Operative, Pain, Chronic Pain
- Being tested
- In hospital pain evaluation, In hospital questionnaires, Telephone contact at 3 months
- Keywords
- pain trajectory
- Medical subject headings
- Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In hospital pain evaluationOther
Patients will evaluate their pain levels via a verbal numerical scale on days 1(or-1), 2, 3, 4, 5, 6 \& 7.
In hospital questionnairesOther
Patients are required to fill out the PCS questionnaire between on day -1 or +1.
Telephone contact at 3 monthsOther
Patients will be contacted at 3 months post-surgery for pain questionnaires DN4 and EQ5D5L.
| Study group | Role | What they receive |
|---|---|---|
| The study population | The study population consists of adult surgery patients at the Nîmes University Hospital, with recruitment based on the operating theater program and for a predefined list of surgeries. Receives: Other: In hospital pain evaluation; Other: In hospital questionnaires; Other: Telephone contact at 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain trajectory for the first 7 post-operative days.
The pain trajectory is the change in pain level evaluated by verbal numerical pain (from 0 to 10) from day 0 (surgery) to day 7.
Measured: Day 7
Secondary outcomes (13)
The DN4 questionnaire
The Douleur Neuropathique 4 (DN4) questionnaire was developed by the French Neuropathic Pain Group and is a simple and objective tool, with the ability to distinguish nociceptive from neuropathic pain
Measured: month 3
The EuroQuol EQ5D5L questionnaire
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: month 3
Since the surgery, do you have persistent pain? yes/no
Since the surgery, do you have persistent pain? yes/no
Measured: month 3
Verbal numerical scale for pain (ranging from 0 to 10)
Verbal numerical scale for pain (ranging from 0 to 10)
Measured: month 3
Have you had complications from your surgery? yes/no
Have you had complications from your surgery? yes/no
Measured: month 3
Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain.
Measured: day -1 or day +1
Cumulative consumption of antalgic drugs
Cumulative consumption of antalgic drugs
Measured: day -1 or day +1
Cumulative consumption of antalgic drugs
Cumulative consumption of antalgic drugs
Measured: day 2
Cumulative consumption of antalgic drugs
Cumulative consumption of antalgic drugs
Measured: day 3
Cumulative consumption of antalgic drugs
Cumulative consumption of antalgic drugs
Measured: day 4
Cumulative consumption of antalgic drugs
Cumulative consumption of antalgic drugs
Measured: day 5
Cumulative consumption of antalgic drugs
Cumulative consumption of antalgic drugs
Measured: day 6
Cumulative consumption of antalgic drugs
Cumulative consumption of antalgic drugs
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start23 Feb 2021
- Primary completion23 Feb 2024 (estimated)
- Study completion23 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surgical Procedures, OperativeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joël L'Hermite, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326737
- Sponsor's protocol ID
- LOCAL/2020/PC-02
- Other IDs
- 2020-A03223-36
- Acronym
- ETADOL
- Status last verified
- Apr 2022
- First submitted
- 4 Apr 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lanteri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. doi: 10.1016/j.pain.2004.12.010. Epub 2005 Jan 26.
PubMed 15733628Sullivan, M. J., Bishop, S. R., & Pivik, J. The pain catastrophizing scale: development and validation. Psychological assessment, 1995, 7(4), 524.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain Trajectories After Surgery and Their Potential Relationship With Chronicity at 3 Months: a Single-center Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05326737
- Acronym / sponsor ID
- ETADOL / LOCAL/2020/PC-02
- Conditions
- Surgical Procedures, Operative, Pain, Chronic Pain
- Keywords
- pain trajectory
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 23 Feb 2024 (estimated)
- Study completion
- 23 May 2024 (estimated)
- First posted
- 14 Apr 2022 (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 effective management of acute postoperative pain remains a daily challenge despite the organizational efforts made and the techniques put in place.
Thirty percent of patients who undergo surgery suffer from chronic post-surgical pain, of which 5 to 10% are of severe intensity. Many preoperative, intraoperative, and postoperative factors, related to the patient, the surgical procedure, or the anesthetic technique, have been incriminated as risk factors for chronic post-surgical pain. The severity of acute postoperative pain is recognized as one of the risk factors for the occurrence of chronic post-surgical pain on which we can hope to interact during the peri-operative period.
In this cohort study, we wish to define the typologies of postoperative pain trajectories observed from Day 0 to Day 7 and to estimate the proportion of patients with an abnormal resolution of pain in a model of organization such as that of our institution, in classic hospitalization and in ambulatory care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Other: In hospital pain evaluation, Other: In hospital questionnaires, Other: Telephone contact at 3 monthsThe study population consists of adult surgery patients at the Nîmes University Hospital, with recruitment based on the operating theater program and for a predefined list of surgeries. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult surgery patients at the Nîmes University Hospital, with recruitment based on the operating theater program ffor a predefined list of surgeries.
Key inclusion criteria (4 listed)
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 3 months of follow-up
- The patient has undergone a planned surgical procedure in one of the participating departments
- The patient is willing and able to respond to the study questionnaires
Key exclusion criteria (5 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- It is impossible to correctly inform the patient
- Patient admitted to the ICU and still intubated at day 1
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 |
|---|---|---|
| In hospital pain evaluationPatients will evaluate their pain levels via a verbal numerical scale on days 1(or-1), 2, 3, 4, 5, 6 \& 7. | Other | The study population |
| In hospital questionnairesPatients are required to fill out the PCS questionnaire between on day -1 or +1. | Other | The study population |
| Telephone contact at 3 monthsPatients will be contacted at 3 months post-surgery for pain questionnaires DN4 and EQ5D5L. | Other | The study population |
Primary outcome
The pain trajectory for the first 7 post-operative days.
Time frame: Day 7
The pain trajectory is the change in pain level evaluated by verbal numerical pain (from 0 to 10) from day 0 (surgery) to day 7.
13 secondary outcomes
The DN4 questionnaire
Time frame: month 3
The EuroQuol EQ5D5L questionnaire
Time frame: month 3
Since the surgery, do you have persistent pain? yes/no
Time frame: month 3
Verbal numerical scale for pain (ranging from 0 to 10)
Time frame: month 3
Have you had complications from your surgery? yes/no
Time frame: month 3
Pain Catastrophizing Scale (PCS)
Time frame: day -1 or day +1
Cumulative consumption of antalgic drugs
Time frame: day -1 or day +1
Cumulative consumption of antalgic drugs
Time frame: day 2
Cumulative consumption of antalgic drugs
Time frame: day 3
Cumulative consumption of antalgic drugs
Time frame: day 4
Cumulative consumption of antalgic drugs
Time frame: day 5
Cumulative consumption of antalgic drugs
Time frame: day 6
Cumulative consumption of antalgic drugs
Time frame: day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Background: PubMed 15733628Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lanteri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. doi: 10.1016/j.pain.2004.12.010. Epub 2005 Jan 26.
- BackgroundSullivan, M. J., Bishop, S. R., & Pivik, J. The pain catastrophizing scale: development and validation. Psychological assessment, 1995, 7(4), 524.
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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.
Joël L'Hermite, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
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 Surgical Procedures, Operative and Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 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: status not confirmed, as of the sponsor's last update on 14 Apr 2022. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joël L'Hermite, MD (+33.(0)4.66.68.36.18, joel.lhermite@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pain trajectory for the first 7 post-operative days. (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05326737, which also lists 2 linked publications.
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 14 Apr 2022.