Chronic Postsurgical PainPRE-OPIOIDNCT07717151
Prevention of Chronic Postsurgical Pain in Chronic Opioid Users:
A study testing standard institutional perioperative management and specialized teleconsultation in people with Chronic Postsurgical Pain and Chronic Opioid Users, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Chronic opioid users undergoing surgery are at increased risk of CPSP, contributing to long-term disability, decreased quality of life, and prolonged opioid exposure. Existing preventive strategies remain limited, and early postoperative monitoring may represent a key opportunity for intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Postsurgical Pain, Chronic Opioid Users, Transitional Pain Service
- What is being tested?
- standard institutional perioperative management and specialized teleconsultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2026to Jan 2029
- 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
- Age ≥18 years
- Elective non-urgent surgery with expected moderate or higher postoperative pain
- Chronic preoperative opioid use
- Written informed consent
- affiliated with a national social security scheme
Who cannot join
- Ambulatory surgery
- Endoscopic or palliative surgery
- Patients receiving opioid substitution therapy
- Non-medical opioid use
- Intrathecal/epidural analgesia or implanted neurostimulator
- Legally protected adults
- Severe psychiatric or neurodegenerative disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens-Picardie
Amiens, 80054
Paul TARPIN, MD, 0322087980, Tarpin.Paul@chu-amiens.fr
Ottilie Fumery, MD
About this study
Official title: Ransitional Teleconsultation to Prevent Chronic Postsurgical Pain in Chronic Opioid Users
Chronic opioid users undergoing surgery are at increased risk of CPSP, contributing to long-term disability, decreased quality of life, and prolonged opioid exposure. Existing preventive strategies remain limited, and early postoperative monitoring may represent a key opportunity for intervention. Evidence suggests that transitional pain services can improve outcomes by optimizing pain control and reducing long-term opioid consumption, but implementation is heterogeneous and often resource-intensive. Telemedicine offers a scalable alternative, enabling early specialized evaluation and timely therapeutic adjustments while maintaining accessibility. This randomized controlled trial will compare standard postoperative follow-up with standard follow-up plus a specialized teleconsultation performed between postoperative day 15 and 28. The intervention aims to detect insufficiently controlled pain, signs of neuropathic pain, or maladaptive opioid use, and to propose individualized therapeutic adjustments when required.
Participants will be followed for 6 months. Primary assessment will occur at 3 months to determine CPSP incidence. Secondary assessments will include pain trajectory (intensity, neuropathic features, functional interference), opioid consumption and misuse, quality of life, and a descriptive medico- economic evaluation
- Conditions
- Chronic Postsurgical Pain, Chronic Opioid Users, Transitional Pain Service, Postoperative Pain, Perioperative Medicine
- Being tested
- standard institutional perioperative management, specialized teleconsultation
- Keywords
- Chronic postsurgical pain, chronic opioid users, transitional pain service, postoperative pain, perioperative medicine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard institutional perioperative managementOther
standard institutional perioperative management
specialized teleconsultationOther
Patients in the intervention arm participate in a specialized teleconsultation between postoperative day 15-28 to detect poorly controlled pain, neuropathic features, or opioid-related concerns, and to adjust treatment if needed.
| Study group | Role | What they receive |
|---|---|---|
| Standard care + specialized postoperative teleconsultation | Experimental | Standard care + specialized postoperative teleconsultation Receives: Other: standard institutional perioperative management; Other: specialized teleconsultation |
| Standard postoperative care alone | Active comparator | Standard postoperative care alone Receives: Other: standard institutional perioperative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chronic postsurgical pain (CPSP)
Incidence of chronic postsurgical pain (CPSP) at 3 months, defined as:
- new or aggravated postsurgical pain located at the surgical site or innervated territory,
- persistent for ≥3 months,
- intensity ≥3/10 (new pain) or increase ≥2/10 from baseline (aggravation),
- with significant functional impact (≥3/10 on at least one Brief Pain Inventory interference item),
- assessed at day 90 ±14.
Measured: at 3 months
Secondary outcomes (5)
Pain trajectory
Pain trajectory is measured by using intensity (BPI), + neuropathic features (DN4) +Quality of life (EQ-5D-5L)
Measured: at 3 months
Pain trajectory
Pain trajectory is measured with intensity (BPI), neuropathic features (DN4), Quality of life (EQ-5D- 5L)
Measured: at 6 months
Opioid use
Opioid use is defined as oral morphine equivalent consumption, proportion with reduction/discontinuation, POMI-5F, SOWS, DSM-5 OUD criteria
Measured: at 3 months
Opioid use
Opioid use is defined as oral morphine equivalent consumption, proportion with reduction/discontinuation, POMI-5F, SOWS, DSM-5 OUD criteria
Measured: at 6 months
Descriptive medico-economic analysis
Descriptive medico-economic analysis is determined with assessment of direct and indirect costs, descriptive comparison of effectiveness (incidence of CPSP at 6 months),descriptive reporting of utility values derived from EQ-5D-5L at 6 months
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start14 Jan 2026
- Primary completionJul 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Postsurgical PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717151
- Sponsor's protocol ID
- PI2025_843_0191
- Acronym
- PRE-OPIOID
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 21 Jul 2026
- 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ransitional Teleconsultation to Prevent Chronic Postsurgical Pain in Chronic Opioid Users
- ClinicalTrials.gov ID
- NCT07717151
- Acronym / sponsor ID
- PRE-OPIOID / PI2025_843_0191
- Conditions
- Chronic Postsurgical Pain, Chronic Opioid Users, Transitional Pain Service, Postoperative Pain, Perioperative Medicine
- Keywords
- Chronic postsurgical pain, chronic opioid users, transitional pain service, postoperative pain, perioperative medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 21 Jul 2026 (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 opioid users undergoing surgery are at increased risk of CPSP, contributing to long-term disability, decreased quality of life, and prolonged opioid exposure. Existing preventive strategies remain limited, and early postoperative monitoring may represent a key opportunity for intervention. Evidence suggests that transitional pain services can improve outcomes by optimizing pain control and reducing long-term opioid consumption, but implementation is heterogeneous and often resource-intensive. Telemedicine offers a scalable alternative, enabling early specialized evaluation and timely therapeutic adjustments while maintaining accessibility. This randomized controlled trial will compare standard postoperative follow-up with standard follow-up plus a specialized teleconsultation performed between postoperative day 15 and 28. The intervention aims to detect insufficiently controlled pain, signs of neuropathic pain, or maladaptive opioid use, and to propose individualized therapeutic adjustments when required.
Participants will be followed for 6 months. Primary assessment will occur at 3 months to determine CPSP incidence. Secondary assessments will include pain trajectory (intensity, neuropathic features, functional interference), opioid consumption and misuse, quality of life, and a descriptive medico- economic evaluation
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care + specialized postoperative teleconsultation | Experimental | Other: standard institutional perioperative management, Other: specialized teleconsultationStandard care + specialized postoperative teleconsultation |
| Standard postoperative care alone | Active comparator | Other: standard institutional perioperative managementStandard postoperative care alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Elective non-urgent surgery with expected moderate or higher postoperative pain
- Chronic preoperative opioid use
- Written informed consent
- affiliated with a national social security scheme
Key exclusion criteria (7 listed)
- Ambulatory surgery
- Endoscopic or palliative surgery
- Patients receiving opioid substitution therapy
- Non-medical opioid use
- Intrathecal/epidural analgesia or implanted neurostimulator
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 |
|---|---|---|
| standard institutional perioperative managementstandard institutional perioperative management | Other | Standard care + specialized postoperative teleconsultation, Standard postoperative care alone |
| specialized teleconsultationPatients in the intervention arm participate in a specialized teleconsultation between postoperative day 15-28 to detect poorly controlled pain, neuropathic features, or opioid-related concerns, and to adjust treatment if needed. | Other | Standard care + specialized postoperative teleconsultation |
Primary outcome
Incidence of chronic postsurgical pain (CPSP)
Time frame: at 3 months
Incidence of chronic postsurgical pain (CPSP) at 3 months, defined as: * new or aggravated postsurgical pain located at the surgical site or innervated territory, * persistent for ≥3 months, * intensity ≥3/10 (new pain) or increase ≥2/10 from baseline (aggravation), * with significant functional impact (≥3/10 on at least one Brief Pain Inventory interference item), * assessed at day 90 ±14.
5 secondary outcomes
Pain trajectory
Time frame: at 3 months
Pain trajectory
Time frame: at 6 months
Opioid use
Time frame: at 3 months
Opioid use
Time frame: at 6 months
Descriptive medico-economic analysis
Time frame: at 6 months
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 21 Jul 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard institutional perioperative management and specialized teleconsultation in people with Chronic Postsurgical Pain and Chronic Opioid Users, run by Centre Hospitalier Universitaire, Amiens 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 21 Jul 2026. 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?
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 Paul Tarpin, MD (33+3.22.08.79.80, Tarpin.paul@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of chronic postsurgical pain (CPSP) (time frame: at 3 months). 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 21 Jul 2026.