Chronic Postoperative PainDROPSNCT07160595
Benefit on Chronic Pain of Early Screening and Management of Patients With Persistent Postoperative Pain at 3 Months
A study testing Early management of postoperative pain at 3 months detected using sms in people with Chronic Postoperative Pain, run by Fondation Hôpital Saint-Joseph at 16 sites in France.
Trial summary
Chronic postoperative pain has an overall incidence of approximately 30%, with 5% to 10% of cases classified as severe (numerical rating scale > 6/10). However, its management remains suboptimal, primarily due to underdiagnosis and delayed referral of patients to specialized chronic pain centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Postoperative Pain
- What is being tested?
- Early management of postoperative pain at 3 months detected using sms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,052 participants
- Where
- 16 sitesFrance
- Study dates
- Nov 2025to Apr 2028
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have undergone one of the following procedures:
- Inguinal hernia repair, regardless of the surgical technique used
- Breast reduction
- Mastectomy with or without reconstruction but with lymph node dissection
- Knee arthroscopy or knee ligamentoplasty
- Patients with a smartphone
Show all 9Show fewer
- French-speaking patients
- Patients affiliated with a social security
- Patients who have given their free and informed verbal consent
Who cannot join
- Patients with pain sensitivity defined by the presence of chronic pain, use of level 3 morphine analgesics, use of anxiolytics, gabapentinoids and/or antidepressants
- Patients subject to legal protection measures
- Patients deprived of their liberty
- Pregnant, labouring or breastfeeding patients
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
France16 sites
Hôpital Prive Claude Galien
Boussy-Saint-Antoine
Célia MAMMA, 01 44 12 32 54, cmamma@ghpsj.fr
Olivier MAUPAIN
Hospices Civils de Lyon
Lyon
Célia MAMMA, 01 44 12 32 54, cmamma@ghpsj.fr
Fréderic AUBRUN
Clinique Jules Verne
Nantes
Célia MAMMA, 01 44 12 32 54, cmamma@ghpsj.fr
Sébastien CAMPARD
Hôpital Privé du confluent Santé Atlantique
Nantes
Célia MAMMA, 01 44 12 32 54, cmamma@ghpsj.fr
Gwillerm PLEDEL
AP-HP : Hôpital de la Pitié Salpêtrière
Paris
Célia MAMMA, 01 44 12 32 54, cmamma@ghpsj.fr
Sophie DI-MARIA
AP-HP : Hôpital Saint-Louis
Paris
Célia MAMMA, 01 44 12 32 54, cmamma@ghpsj.fr
Delphine CHERON-LEROY
Clinique Drouot Remusat
Paris
Célia MAMMA, 01 44 12 32 54, cmamma@ghpsj.fr
Cyril QUEMENEUR
Clinique Geoffroy Saint Hilaire
Paris
Célia MAMMA, 01 44 12 32 54, cmamma@ghpsj.fr
Dan Alexandru COSTIN
Hôpital de la Croix Saint-Simon
Paris
Célia MAMMA, 01 44 12 32 54, cmamma@ghpsj.fr
Jean Michel DEVYS
Hôpital Paris Saint-Joseph
Paris
Célia MAMMA, 01 44 12 32 54, cmamma@ghpsj.fr
Fréderic ADAM
Institut Curie : Hôpital de Paris
Paris
Célia MAMMA, 01 44 12 32 54, cmamma@ghpsj.fr
Jane MURET
Institut Mutualiste Montsouris
Paris
Célia MAMMA, 01 44 12 32 54, cmamma@ghpsj.fr
Marc BEAUSSIER
Institut Curie : Hôpital de Saint Cloud
Saint-Cloud
Célia MAMMA, 01 44 12 32 54, cmamma@ghpsj.fr
Aline ALBI
CHU de Saint-Etienne
Saint-Etienne
Célia MAMMA, 01 44 12 32 54, cmamma@ghpsj.fr
David CHARIER
Hôpital Foch
Suresnes
Célia MAMMA, 01 44 12 32 54, cmamma@ghpsj.fr
Morgan LEGUEN
CHU de Toulouse
Toulouse
Célia MAMMA, 01 44 12 32 54, cmamma@ghpsj.fr
Vincent MINVILLE
About this study
Chronic postoperative pain has an overall incidence of approximately 30%, with 5% to 10% of cases classified as severe (numerical rating scale > 6/10). However, its management remains suboptimal, primarily due to underdiagnosis and delayed referral of patients to specialized chronic pain centers.
Improving the screening of patients with chronic postoperative pain is therefore crucial. Our research has shown that early detection of postoperative neuropathic pain is possible using just two text messages (SMS), as early as three months after surgery. Early screening, combined with prompt management, can prevent pain from becoming chronic and mitigate its harmful effects.
Read more
Study design
This study is a cluster crossover randomized trial. All participating centers (n=16) will take part in two sequential study periods:
- Control Period: "Without early treatment at 3 months" During this period, patients with persistent postoperative pain-identified via SMS-will receive treatment at 6 months. This reflects the current standard of care for patients with postoperative pain.
- Intervention Period: "With early treatment at 3 months" During this period, patients with persistent postoperative pain-identified via SMS-will receive early treatment starting at 3 months.
Study Population
The study will include patients undergoing the following minor surgical procedures:
- Inguinal hernia repair
- Breast reduction
- Mastectomy with lymph node dissection
- Knee arthroscopy
- Knee ligament reconstruction
Study Schedule Recruitment Period: 24 months Patient Follow-up: 6 months Total Estimated Study Duration: 30 months
- Conditions
- Chronic Postoperative Pain
- Being tested
- Early management of postoperative pain at 3 months detected using sms
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early management of postoperative pain at 3 months detected using smsOther
During this period, patients with persistent post-operative pain, identified through SMS screening, will receive early treatment starting at 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Control period 'without early intervention at 3 months' | No intervention | During this period, patients with persistent post-operative pain, identified through SMS screening, will be treated at 6 months (this reflects the current standard experience for patients with postoperative pain). |
| Intervention period 'with early intervention at 3 months' | Experimental | During this period, patients with persistent post-operative pain, identified through SMS screening, will receive early treatment starting at 3 months. Receives: Other: Early management of postoperative pain at 3 months detected using sms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with chronic post-operative pain at 6 months.
Measured: 6 months post-operative
Secondary outcomes (4)
Types of chronic post-operative pain at 3 and 6 months: frequency of neuropathic pain and pain due to excessive nociception
Measured: 3 and 6 months post-operative
Proportion of patients responding to SMS during the various assessments
Measured: 3 and 6 months post-operative
Sensitivity and specificity of SMS for diagnosing pain with neuropathic characteristics post-operatively at 3 and 6 months
Measured: 3 and 6 month post-operative
Proportion of patients with pain at 3 and 6 months according to the type of surgery
Measured: 3 and 6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study startNov 2025 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Postoperative PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a cluster crossover randomized trial. All participating centers (n=16) will take part in two sequential study periods: * Control Period: "Without early treatment at 3 months" During this period, patients with persistent postoperative pain-identified via SMS-will receive treatment at 6 months. This reflects the current standard of care for patients with postoperative pain. * Intervention Period: "With early treatment at 3 months" During this period, patients with persistent postoperative pain-identified via SMS-will receive early treatment starting at 3 months. Each center will be randomized into one of two sequences: "control period followed by intervention period" or "intervention period followed by control period."
- Masking
- None (open label)
- Enrolment
- 2,052 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160595
- Sponsor's protocol ID
- 731_DROPS
- Other IDs
- ID RCB
- Acronym
- DROPS
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit on Chronic Pain of Early Screening and Management of Patients With Persistent Postoperative Pain at 3 Months
- ClinicalTrials.gov ID
- NCT07160595
- Acronym / sponsor ID
- DROPS / 731_DROPS
- Conditions
- Chronic Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,052 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 8 Sep 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 has an overall incidence of approximately 30%, with 5% to 10% of cases classified as severe (numerical rating scale > 6/10). However, its management remains suboptimal, primarily due to underdiagnosis and delayed referral of patients to specialized chronic pain centers.
Improving the screening of patients with chronic postoperative pain is therefore crucial. Our research has shown that early detection of postoperative neuropathic pain is possible using just two text messages (SMS), as early as three months after surgery. Early screening, combined with prompt management, can prevent pain from becoming chronic and mitigate its harmful effects.
Study design
This study is a cluster crossover randomized trial. All participating centers (n=16) will take part in two sequential study periods:
- Control Period: "Without early treatment at 3 months" During this period, patients with persistent postoperative pain-identified via SMS-will receive treatment at 6 months. This reflects the current standard of care for patients with postoperative pain.
- Intervention Period: "With early treatment at 3 months" During this period, patients with persistent postoperative pain-identified via SMS-will receive early treatment starting at 3 months.
Study Population
The study will include patients undergoing the following minor surgical procedures:
- Inguinal hernia repair
- Breast reduction
- Mastectomy with lymph node dissection
- Knee arthroscopy
- Knee ligament reconstruction
Study Schedule Recruitment Period: 24 months Patient Follow-up: 6 months Total Estimated Study Duration: 30 months
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a cluster crossover randomized trial. All participating centers (n=16) will take part in two sequential study periods: * Control Period: "Without early treatment at 3 months" During this period, patients with persistent postoperative pain-identified via SMS-will receive treatment at 6 months. This reflects the current standard of care for patients with postoperative pain. * Intervention Period: "With early treatment at 3 months" During this period, patients with persistent postoperative pain-identified via SMS-will receive early treatment starting at 3 months. Each center will be randomized into one of two sequences: "control period followed by intervention period" or "intervention period followed by control period."
| Arm | Type | Receives |
|---|---|---|
| Control period 'without early intervention at 3 months' | No intervention | –During this period, patients with persistent post-operative pain, identified through SMS screening, will be treated at 6 months (this reflects the current standard experience for patients with postoperative pain). |
| Intervention period 'with early intervention at 3 months' | Experimental | Other: Early management of postoperative pain at 3 months detected using smsDuring this period, patients with persistent post-operative pain, identified through SMS screening, will receive early treatment starting at 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who have undergone one of the following procedures:
Key exclusion criteria (4 listed)
- Patients with pain sensitivity defined by the presence of chronic pain, use of level 3 morphine analgesics, use of anxiolytics, gabapentinoids and/or antidepressants
- Patients subject to legal protection measures
- Patients deprived of their liberty
- Pregnant, labouring or breastfeeding patients
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 |
|---|---|---|
| Early management of postoperative pain at 3 months detected using smsDuring this period, patients with persistent post-operative pain, identified through SMS screening, will receive early treatment starting at 3 months. | Other | Intervention period 'with early intervention at 3 months' |
Primary outcome
Proportion of patients with chronic post-operative pain at 6 months.
Time frame: 6 months post-operative
4 secondary outcomes
Types of chronic post-operative pain at 3 and 6 months: frequency of neuropathic pain and pain due to excessive nociception
Time frame: 3 and 6 months post-operative
Proportion of patients responding to SMS during the various assessments
Time frame: 3 and 6 months post-operative
Sensitivity and specificity of SMS for diagnosing pain with neuropathic characteristics post-operatively at 3 and 6 months
Time frame: 3 and 6 month post-operative
Proportion of patients with pain at 3 and 6 months according to the type of surgery
Time frame: 3 and 6 months post-operative
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 8 Sep 2025.
- Individual participant dataSharing planned: No
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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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early management of postoperative pain at 3 months detected using sms in people with Chronic Postoperative Pain, run by Fondation Hôpital Saint-Joseph at 16 sites 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 9 inclusion and 4 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 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
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 Frédéric ADAM, Doctor of Medicine (01 44 12 36 18, fadam@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with chronic post-operative pain at 6 months. (time frame: 6 months post-operative). 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 8 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.