Surgical Procedures, OperativePATCHNCT02599233
Characterization of Post-operative Pain Trajectories Over Seven Days and Links With Chronicity
An observational study of Surgical Procedures, Operative and Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to establish the postoperative "pain pathways" observed from D1 to D7 in the context of the current management after orthopedic, digestive, obstetrics and gynecology, urology, neurosurgery, vascular and thoracicn surgeries. 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?
- Telephone conctact at 3 months, In hospital pain evaluation and In hospital questionnaires
- How many people
- 392 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to 3 Nov 2016
- 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 for a predefined six month period and for a predefined list of surgeries. The latter list of surgical acts was established according to the Medicalization of Information Systems Progam (PMSI) database. Patients are recruited either the day before or the day after surgery, in their respective departments.
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 (HADS, PCS, EN, DN4)
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.
About this study
Official title: Characterization of Post-operative Pain Trajectories Over Seven Days and Their Potential Links With Chronicity After 3 Months: a Single-center, Prospective, Pilot Cohort Study at the Nîmes University Hospital
The main objective of this study is to establish the postoperative "pain pathways" observed from D1 to D7 in the context of the current management after orthopedic, digestive, obstetrics and gynecology, urology, neurosurgery, vascular and thoracicn surgeries.
Read the detailed description
The secondary objectives of this study are:
- To assess the incidence of Post-Surgical Chronic Pain (PSCP) Chronic 3 months post intervention.
- To asses the incidence of neuropathic type pain (DN4 Questionnaire) at 3 months post intervention.
- To study the potential links between pain trajectories and the presence or absence of PSCP.
- To study the potential links between the presence or absence of PSCP and known risk factors for PSCP (patient-related data, data on the surgery, anesthesia data).
- Conditions
- Surgical Procedures, Operative, Pain, Chronic Pain
- Being tested
- Telephone conctact at 3 months, In hospital pain evaluation, In hospital questionnaires
- 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.
Telephone conctact at 3 monthsOther
Patients will be contacted at 3 months post-surgery for pain questionnaires.
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 HADS and PCS questionnaires between on day -1 or +1.
| 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 for a predefined six month period and for a predefined list of surgeries. The latter list of surgical acts was established according to the Medicalization of Information Systems Progam (PMSI) database. Patients are recruited either the day before or the day after surgery, in their respective departments.
Interventions:
* In hospital pain evaluation
* In hospital questionnaires
* Telephone conctact at 3 months Receives: Other: Telephone conctact at 3 months; Other: In hospital pain evaluation; Other: In hospital questionnaires |
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 vector of 7 verbal numerical pain estimates (from 0 to 10) taken over 7 days (days 1 (or -1), 2, 3, 4, 5, 6 \& 7).
Day 0 is the day of surgery.
Measured: Day 7 post-surgery
Secondary outcomes (14)
The DN4 questionnaire
Measured: month 3
Since the surgery, do you have persistent pain? yes/no
Measured: month 3
Is it the same pain before the surgery? yes/no
Measured: month 3
Verbal numberical scale for pain (ranging from 0 to 10)
Measured: month 3
Have you had complications from your surgery? yes/no
Measured: month 3
Hospital Anxiety and Depression Scale (HADS)
Measured: day -1 or day +1
Pain Catastrophizing Scale (PCS)
Measured: day -1 or day +1
Cumulative consumption of antalgic drugs
Measured: day -1 or day +1
Cumulative consumption of antalgic drugs
Measured: day 2
Cumulative consumption of antalgic drugs
Measured: day 3
Cumulative consumption of antalgic drugs
Measured: day 4
Cumulative consumption of antalgic drugs
Measured: day 5
Cumulative consumption of antalgic drugs
Measured: day 6
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 posted6 Nov 2015 (estimated)
- Study startMar 2016
- Primary completion3 Nov 2016
- Study completion3 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 392 participants (actual)
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
- NCT02599233
- Sponsor's protocol ID
- LOCAL/2015/JLH-01
- Other IDs
- 2015-A00868-41
- Acronym
- PATCH
- Status last verified
- Jan 2017
- First submitted
- 4 Nov 2015
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
L'Hermite J, Page MG, Chevallier T, Occean B, Viel E, Bredeau O, Lefrant JY, Cuvillon P. Characterisation of pragmatic postoperative PAin Trajectories over seven days and their association with CHronicity after 3 months: a prospective, pilot cohort study (PATCH study). Anaesth Crit Care Pain Med. 2021 Feb;40(1):100793. doi: 10.1016/j.accpm.2020.100793. Epub 2020 Dec 23.
PubMed 33359373
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Post-operative Pain Trajectories Over Seven Days and Their Potential Links With Chronicity After 3 Months: a Single-center, Prospective, Pilot Cohort Study at the Nîmes University Hospital
- ClinicalTrials.gov ID
- NCT02599233
- Acronym / sponsor ID
- PATCH / LOCAL/2015/JLH-01
- Conditions
- Surgical Procedures, Operative, Pain, Chronic Pain
- Keywords
- pain trajectory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 3 Nov 2016 (actual)
- Study completion
- 3 Nov 2016 (actual)
- First posted
- 6 Nov 2015 (estimated)
- 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 main objective of this study is to establish the postoperative "pain pathways" observed from D1 to D7 in the context of the current management after orthopedic, digestive, obstetrics and gynecology, urology, neurosurgery, vascular and thoracicn surgeries.
Detailed description
The secondary objectives of this study are:
- To assess the incidence of Post-Surgical Chronic Pain (PSCP) Chronic 3 months post intervention.
- To asses the incidence of neuropathic type pain (DN4 Questionnaire) at 3 months post intervention.
- To study the potential links between pain trajectories and the presence or absence of PSCP.
- To study the potential links between the presence or absence of PSCP and known risk factors for PSCP (patient-related data, data on the surgery, anesthesia data).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Other: Telephone conctact at 3 months, Other: In hospital pain evaluation, Other: In hospital questionnairesThe study population consists of adult surgery patients at the Nîmes University Hospital, with recruitment based on the operating theater program for a predefined six month period and for a predefined list of surgeries. The latter list of surgical acts was established according to the Medicalization of Information Systems Progam (PMSI) database. Patients are recruited either the day before or the day after surgery, in their respective departments. Interventions: * In hospital pain evaluation * In hospital questionnaires * Telephone conctact at 3 months |
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 for a predefined six month period and for a predefined list of surgeries. The latter list of surgical acts was established according to the Medicalization of Information Systems Progam (PMSI) database. Patients are recruited either the day before or the day after surgery, in their respective departments.
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 (HADS, PCS, EN, DN4)
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 |
|---|---|---|
| Telephone conctact at 3 monthsPatients will be contacted at 3 months post-surgery for pain questionnaires. | Other | The study population |
| 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 HADS and PCS questionnaires between on day -1 or +1. | Other | The study population |
Primary outcome
The pain trajectory for the first 7 post-operative days.
Time frame: Day 7 post-surgery
The pain trajectory is the vector of 7 verbal numerical pain estimates (from 0 to 10) taken over 7 days (days 1 (or -1), 2, 3, 4, 5, 6 \& 7). Day 0 is the day of surgery.
14 secondary outcomes
The DN4 questionnaire
Time frame: month 3
Since the surgery, do you have persistent pain? yes/no
Time frame: month 3
Is it the same pain before the surgery? yes/no
Time frame: month 3
Verbal numberical 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
Hospital Anxiety and Depression Scale (HADS)
Time frame: day -1 or day +1
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 33359373L'Hermite J, Page MG, Chevallier T, Occean B, Viel E, Bredeau O, Lefrant JY, Cuvillon P. Characterisation of pragmatic postoperative PAin Trajectories over seven days and their association with CHronicity after 3 months: a prospective, pilot cohort study (PATCH study). Anaesth Crit Care Pain Med. 2021 Feb;40(1):100793. doi: 10.1016/j.accpm.2020.100793. Epub 2020 Dec 23.
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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: finished, as of the sponsor's last update on 19 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The pain trajectory for the first 7 post-operative days. (time frame: Day 7 post-surgery). 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 NCT02599233, which also lists 1 linked publication.
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 19 Nov 2025.