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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Paul Tarpin, MD
- Telefonnummer: 33+3.22.08.79.80
- E-post: Tarpin.paul@chu-amiens.fr
Studieorter
-
-
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Amiens, Frankrike, 80054
- Rekrytering
- CHU Amiens-Picardie
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Kontakt:
- Paul TARPIN, MD
- Telefonnummer: 0322087980
- E-post: Tarpin.Paul@chu-amiens.fr
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Underutredare:
- Ottilie Fumery, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of chronic postsurgical pain (CPSP)
Tidsram: at 3 months
|
Incidence of chronic postsurgical pain (CPSP) at 3 months, defined as:
|
at 3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain trajectory
Tidsram: at 3 months
|
Pain trajectory is measured by using intensity (BPI), + neuropathic features (DN4) +Quality of life (EQ-5D-5L)
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at 3 months
|
|
Pain trajectory
Tidsram: 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
|
|
Opioid use
Tidsram: 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
|
|
Opioid use
Tidsram: at 6 months
|
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
Tidsram: at 6 months
|
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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PI2025_843_0191
Plan för individuella deltagardata (IPD)
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