- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07717151
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paul Tarpin, MD
- Phone Number: 33+3.22.08.79.80
- Email: Tarpin.paul@chu-amiens.fr
Study Locations
-
-
-
Amiens, France, 80054
- Recruiting
- CHU Amiens-Picardie
-
Contact:
- Paul TARPIN, MD
- Phone Number: 0322087980
- Email: Tarpin.Paul@chu-amiens.fr
-
Sub-Investigator:
- Ottilie Fumery, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Standard care + specialized postoperative teleconsultation
|
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.
|
|
Active Comparator: Standard postoperative care alone
|
standard institutional perioperative management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of chronic postsurgical pain (CPSP)
Time Frame: at 3 months
|
Incidence of chronic postsurgical pain (CPSP) at 3 months, defined as:
|
at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain trajectory
Time Frame: at 3 months
|
Pain trajectory is measured by using intensity (BPI), + neuropathic features (DN4) +Quality of life (EQ-5D-5L)
|
at 3 months
|
|
Pain trajectory
Time Frame: at 6 months
|
Pain trajectory is measured with intensity (BPI), neuropathic features (DN4), Quality of life (EQ-5D- 5L)
|
at 6 months
|
|
Opioid use
Time Frame: at 3 months
|
Opioid use is defined as oral morphine equivalent consumption, proportion with reduction/discontinuation, POMI-5F, SOWS, DSM-5 OUD criteria
|
at 3 months
|
|
Opioid use
Time Frame: at 6 months
|
Opioid use is defined as oral morphine equivalent consumption, proportion with reduction/discontinuation, POMI-5F, SOWS, DSM-5 OUD criteria
|
at 6 months
|
|
Descriptive medico-economic analysis
Time Frame: 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
|
at 6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2025_843_0191
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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