Prevention of Chronic Postsurgical Pain in Chronic Opioid Users: (PRE-OPIOID)
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Paul Tarpin, MD
- Telefonnummer: 33+3.22.08.79.80
- E-post: Tarpin.paul@chu-amiens.fr
Studiesteder
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Amiens, Frankrike, 80054
- Rekruttering
- CHU Amiens-Picardie
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Ta kontakt med:
- Paul TARPIN, MD
- Telefonnummer: 0322087980
- E-post: Tarpin.Paul@chu-amiens.fr
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Underetterforsker:
- Ottilie Fumery, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Standard care + specialized postoperative teleconsultation
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standard institutional perioperative management
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.
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Aktiv komparator: Standard postoperative care alone
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standard institutional perioperative management
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of chronic postsurgical pain (CPSP)
Tidsramme: at 3 months
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Incidence of chronic postsurgical pain (CPSP) at 3 months, defined as:
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at 3 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pain trajectory
Tidsramme: at 3 months
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Pain trajectory is measured by using intensity (BPI), + neuropathic features (DN4) +Quality of life (EQ-5D-5L)
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at 3 months
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Pain trajectory
Tidsramme: at 6 months
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Pain trajectory is measured with intensity (BPI), neuropathic features (DN4), Quality of life (EQ-5D- 5L)
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at 6 months
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Opioid use
Tidsramme: at 3 months
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Opioid use is defined as oral morphine equivalent consumption, proportion with reduction/discontinuation, POMI-5F, SOWS, DSM-5 OUD criteria
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at 3 months
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Opioid use
Tidsramme: at 6 months
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Opioid use is defined as oral morphine equivalent consumption, proportion with reduction/discontinuation, POMI-5F, SOWS, DSM-5 OUD criteria
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at 6 months
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Descriptive medico-economic analysis
Tidsramme: at 6 months
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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
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at 6 months
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PI2025_843_0191
Plan for individuelle deltakerdata (IPD)
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