Chronic Post-operative PainPhase 3EVADRAINSNCT07108582
Reducing Chronic Pain After Lung Surgery: A Trial of Limiting NSAIDs During Recovery
A Phase 3 study testing no NSAID and protocol for administering NSAIDs already used in routine care in people with Chronic Post-operative Pain, run by University Hospital, Strasbourg, France.
Trial summary
Chronic postoperative pain (CPOP) after video-assisted thoracic surgery (VATS) is severe because it results from lesions at multiple levels: incisions, pulmonary or nerve contusions. PCOD is defined by the IASP (International Association for the Study of Pain) as persistent pain 3 months after surgery. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Chronic Post-operative Pain
- What is being tested?
- no NSAID and protocol for administering NSAIDs already used in routine care
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients aged 18 to 75
- Patients scheduled for video-assisted thoracic surgery
- Able to give informed consent to participate in the study
- Affiliated to a social health insurance scheme
Who cannot join
- History of renal insufficiency or chronic pain
- Surgical contraindications to NSAIDs (talc surgery)
- Contraindications to NSAIDs described in the VIDAL RCP (renal insufficiency, allergy, etc.)
- History of chronic use of opioids or anti-inflammatories (continuous use for more than 3 months in the year preceding surgery)
- Urgent surgery;
- Participation in another interventional drug clinical trial.
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- Impossibility of giving the subject informed information in the event of difficulties in understanding the subject
- Incapacitated subject (subject to a legal protection measure: safeguard of justice, curatorship, guardianship, future protection mandate, family habilitation)
- Pregnant or breast-feeding
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Impact of a Strategy of Perioperative NSAID Suppression in Patients Undergoing Video-assisted Thoracic Surgery (VATS) on the Presence of Chronic Postoperative Pain (CPOP): a Randomised Clinical Trial
Chronic postoperative pain (CPOP) after video-assisted thoracic surgery (VATS) is severe because it results from lesions at multiple levels: incisions, pulmonary or nerve contusions. PCOD is defined by the IASP (International Association for the Study of Pain) as persistent pain 3 months after surgery. It affects around 30% of patients and significantly impairs recovery and quality of life.
One of the many factors contributing to the appearance of PCOD is acute perioperative pain. To combat this acute pain and limit postoperative chronic pain, a multimodal analgesia strategy is necessary, particularly during thoracic surgery with a high nociceptive potential. This type of protocol will enable acute pain to be controlled by various means: tier 1 analgesics (paracetamol, NSAIDs), tier 2 (nefopam, tramadol) and tier 3 (opioid drugs), locoregional anaesthesia, co-analgesics and non-medicinal techniques. Thus, avoiding NSAIDs will have no effect on the increase in acute pain. A study of the impact of eliminating NSAIDs on chronic pain can therefore be carried out without increasing patients' acute pain.
Read more
A team from McGill University, Montreal, Canada, recently discovered a paradoxical effect of anti-inflammatory drugs on the chronicisation of pain. They demonstrated that although anti-inflammatory drugs initially had an acute analgesic effect, they induced neutrophil depletion and a drastic change in the transcriptome postoperatively, leading to more chronic pain. These studies highlight the fact that although NSAIDs have an acute analgesic effect, their use could ultimately prove counterproductive by encouraging the development of CD. However, to date there are no studies demonstrating that a minimum dose or duration of NSAID treatment leads to the development of DCPO. On the basis of these results, it is justified to assess the impact of NSAIDs widely used in routine care in thoracic surgery on the development of DCPO.
In order to improve pain management in the intraoperative phase, nociception monitoring is necessary. The PMD200® (Medasense Biometrics Ltd.) is the most recent monitor designed for this purpose, having demonstrated sensitivity and specificity in detecting nociceptive stimuli under general anaesthesia (4). It will make it possible to guide the administration of analgesic agents by displaying a nociception index (NOL index).
Our hypothesis, based on this work, is that anti-inflammatory drugs, despite having an acute analgesic effect, could promote the development of DCPO after VATS.
- Conditions
- Chronic Post-operative Pain
- Being tested
- no NSAID, protocol for administering NSAIDs already used in routine care
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no NSAIDDrug
no NSAID but a placebo with identical galenic formulations to maintain blindness at all times during participation in the study
protocol for administering NSAIDs already used in routine careDrug
- 100 mg ketoprofen LP orally administered 30 minutes before surgery,
- 50 mg ketoprofen intravenously at the end of surgery
- then 100 mg ketoprofen LP PO twice a day for 7 days following surgery
| Study group | Role | What they receive |
|---|---|---|
| AINS+ | Active comparator | * 100 mg ketoprofen LP orally administered 30 minutes before surgery,
* 50 mg ketoprofen intravenously at the end of surgery
* then 100 mg ketoprofen LP PO twice a day for 7 days following surgery Receives: Drug: protocol for administering NSAIDs already used in routine care |
| AINS- | Experimental | no NSAID but a placebo with identical galenic formulations to maintain blindness at all times during participation in the study Receives: Drug: no NSAID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Postoperative Pain at 3 Months Using a Numerical Rating Scale (NRS)
Measured: 3 months post-op
Secondary outcomes (12)
Assessment of Maximum Pain Scores at Rest and During Mobilisation Using a Numerical Rating Scale
Measured: Days 0, 1, 3, 1 month and 3 months post-op
Assessment of Neuropathic Pain Using the DN4 Questionnaire
Measured: Days 1, 3, 1 month and 3 months post-op
Cumulative Morphine Equivalent Dose of Opioids Administered Intraoperatively
Measured: Days 1, 3, 1 month and 3 months post-op
Length of Hospital Stay in Both Patient Groups
Measured: up to 3 months post-op
QoR-15 Score
Measured: 1 month and 3 months post-op
Collection of Adverse Events and Serious Adverse Events
Measured: up to 3 months post-op
Global Proteomic and Transcriptomic (RNA-seq) Analysis and Targeted RT-qPCR of Blood Samples
Measured: Days 1, 3 and 3 months post-op
Blood tests for Complete Blood Count by cytometry
Erythrocytes, leukocytes, thrombocytes and associated indices (haemoglobin, haematocrit, etc.)
Measured: Days 0, 1, and 3 months post-op
SF-36 Score
Measured: 1 month and 3 months post-op
Physical and Mental Component Scores
Measured: 1 month and 3 months post-op
Inflammatory Marker Assessment Including Interleukins
Measured: Days 0, 1, and 3 months post-op
Blood tests for C-reactive protein by immunoassay
The results are expressed in mg/L (milligrams per litre)
Measured: Days 0, 1, and 3 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Post-operative PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- phase 3, double-blind, multicentre, placebo-controlled, randomised, parallel-arm trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108582
- Sponsor's protocol ID
- 9797
- Acronym
- EVADRAINS
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Strategy of Perioperative NSAID Suppression in Patients Undergoing Video-assisted Thoracic Surgery (VATS) on the Presence of Chronic Postoperative Pain (CPOP): a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT07108582
- Acronym / sponsor ID
- EVADRAINS / 9797
- Conditions
- Chronic Post-operative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 7 Aug 2025 (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.
Chronic postoperative pain (CPOP) after video-assisted thoracic surgery (VATS) is severe because it results from lesions at multiple levels: incisions, pulmonary or nerve contusions. PCOD is defined by the IASP (International Association for the Study of Pain) as persistent pain 3 months after surgery. It affects around 30% of patients and significantly impairs recovery and quality of life.
One of the many factors contributing to the appearance of PCOD is acute perioperative pain. To combat this acute pain and limit postoperative chronic pain, a multimodal analgesia strategy is necessary, particularly during thoracic surgery with a high nociceptive potential. This type of protocol will enable acute pain to be controlled by various means: tier 1 analgesics (paracetamol, NSAIDs), tier 2 (nefopam, tramadol) and tier 3 (opioid drugs), locoregional anaesthesia, co-analgesics and non-medicinal techniques. Thus, avoiding NSAIDs will have no effect on the increase in acute pain. A study of the impact of eliminating NSAIDs on chronic pain can therefore be carried out without increasing patients' acute pain.
A team from McGill University, Montreal, Canada, recently discovered a paradoxical effect of anti-inflammatory drugs on the chronicisation of pain. They demonstrated that although anti-inflammatory drugs initially had an acute analgesic effect, they induced neutrophil depletion and a drastic change in the transcriptome postoperatively, leading to more chronic pain. These studies highlight the fact that although NSAIDs have an acute analgesic effect, their use could ultimately prove counterproductive by encouraging the development of CD. However, to date there are no studies demonstrating that a minimum dose or duration of NSAID treatment leads to the development of DCPO. On the basis of these results, it is justified to assess the impact of NSAIDs widely used in routine care in thoracic surgery on the development of DCPO.
In order to improve pain management in the intraoperative phase, nociception monitoring is necessary. The PMD200® (Medasense Biometrics Ltd.) is the most recent monitor designed for this purpose, having demonstrated sensitivity and specificity in detecting nociceptive stimuli under general anaesthesia (4). It will make it possible to guide the administration of analgesic agents by displaying a nociception index (NOL index).
Our hypothesis, based on this work, is that anti-inflammatory drugs, despite having an acute analgesic effect, could promote the development of DCPO after VATS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- phase 3, double-blind, multicentre, placebo-controlled, randomised, parallel-arm trial
| Arm | Type | Receives |
|---|---|---|
| AINS+ | Active comparator | Drug: protocol for administering NSAIDs already used in routine care* 100 mg ketoprofen LP orally administered 30 minutes before surgery, * 50 mg ketoprofen intravenously at the end of surgery * then 100 mg ketoprofen LP PO twice a day for 7 days following surgery |
| AINS- | Experimental | Drug: no NSAIDno NSAID but a placebo with identical galenic formulations to maintain blindness at all times during participation in the study |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 18 to 75
- Patients scheduled for video-assisted thoracic surgery
- Able to give informed consent to participate in the study
- Affiliated to a social health insurance scheme
Key exclusion criteria (9 listed)
- History of renal insufficiency or chronic pain
- Surgical contraindications to NSAIDs (talc surgery)
- Contraindications to NSAIDs described in the VIDAL RCP (renal insufficiency, allergy, etc.)
- History of chronic use of opioids or anti-inflammatories (continuous use for more than 3 months in the year preceding surgery)
- Urgent 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 |
|---|---|---|
| no NSAIDno NSAID but a placebo with identical galenic formulations to maintain blindness at all times during participation in the study | Drug | AINS- |
| protocol for administering NSAIDs already used in routine care* 100 mg ketoprofen LP orally administered 30 minutes before surgery, * 50 mg ketoprofen intravenously at the end of surgery * then 100 mg ketoprofen LP PO twice a day for 7 days following surgery | Drug | AINS+ |
Primary outcome
Assessment of Postoperative Pain at 3 Months Using a Numerical Rating Scale (NRS)
Time frame: 3 months post-op
12 secondary outcomes
Assessment of Maximum Pain Scores at Rest and During Mobilisation Using a Numerical Rating Scale
Time frame: Days 0, 1, 3, 1 month and 3 months post-op
Assessment of Neuropathic Pain Using the DN4 Questionnaire
Time frame: Days 1, 3, 1 month and 3 months post-op
Cumulative Morphine Equivalent Dose of Opioids Administered Intraoperatively
Time frame: Days 1, 3, 1 month and 3 months post-op
Length of Hospital Stay in Both Patient Groups
Time frame: up to 3 months post-op
QoR-15 Score
Time frame: 1 month and 3 months post-op
Collection of Adverse Events and Serious Adverse Events
Time frame: up to 3 months post-op
Global Proteomic and Transcriptomic (RNA-seq) Analysis and Targeted RT-qPCR of Blood Samples
Time frame: Days 1, 3 and 3 months post-op
Blood tests for Complete Blood Count by cytometry
Time frame: Days 0, 1, and 3 months post-op
SF-36 Score
Time frame: 1 month and 3 months post-op
Physical and Mental Component Scores
Time frame: 1 month and 3 months post-op
Inflammatory Marker Assessment Including Interleukins
Time frame: Days 0, 1, and 3 months post-op
Blood tests for C-reactive protein by immunoassay
Time frame: Days 0, 1, and 3 months post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing no NSAID and protocol for administering NSAIDs already used in routine care in people with Chronic Post-operative Pain, run by University Hospital, Strasbourg, 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 9 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: opening soon, as of the sponsor's last update on 7 Aug 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walid OULEHRI (+33 3 69 55 12 71, walid.oulehri@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Postoperative Pain at 3 Months Using a Numerical Rating Scale (NRS) (time frame: 3 months post-op). 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 7 Aug 2025.