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The prevalence of Chronic Post-Surgical Pain (CPSP) after knee replacement, defined as pain greater than or equal to 4/10 on the visual analogue scale after the third postoperative month, is recognised as high, with an average of 20% (extremes of 7 to 45%).
These CPSP, when present, cause poor long-term joint functional prognosis and impaired quality of life for patients. Many predictive, pre-, per- and post-operative factors of these CPSP have been identified in recent years. The most common postoperative risk factor found in the literature is the intensity of early pain.
The treatment protocols for this early post-surgical pain are currently and mainly multimodal in nature, combining systemic analgesics (paracetamol, NSAIDs, morphine, gabapentins) and local anaesthetics, administered either in the form of peripheral nerve blocks (continuous or single injection) or in the form of tissue infiltration (TI) performed by the surgeon during the operation.
Very few of these techniques have been evaluated for their ability to reduce the incidence of CPSP. Drugs with antihyperalgesic properties such as ketamine or nefopam have been shown to be of no interest, except to reduce the proportion of pain of a neuropathic nature. Only the continuous femoral block has shown, to date, an interest in IT to reduce the incidence of these CPSP.
The main objective of this study is to show that a multimodal analgesia protocol based on continuous locoregional analgesia by femoral triangle catheterization could reduce the incidence of chronic post surgical pain compared to a protocol based on tissue infiltration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Locoregional analgesia by femoral triangle catheterization | Experimental |
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| Tissue infiltration | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Locoregional analgesia by femoral triangle catheterization |
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| Measure | Description | Time Frame |
|---|---|---|
| Walking Pain Assessment Scale | Self-assessment scale to quantify the patient's pain on a virtual scale from 0 (no pain) to 10 (maximum pain imaginable). Measure is positive when score is >= 4 | Three months from the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jérôme GUILLEY | CHD Vendée | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Victor PAUCHET | Amiens | France | ||||
| Centre Hospitalier de Béthune Beuvry |
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| ID | Title | Description |
|---|---|---|
| FG000 | Locoregional Analgesia by Femoral Triangle Catheterization | Ropivacaine: Locoregional analgesia by femoral triangle catheterization |
| FG001 | Tissue Infiltration | Ropivacaine: Tissue infiltration |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 12, 2022 |
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| Ropivacaine | Drug | Tissue infiltration |
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| Béthune |
| France |
| Centre Hospitalier Départemental Vendée | La Roche-sur-Yon | 85925 | France |
| Hôpital des Diaconesses Croix Saint Simon | Paris | France |
| Hôpital Privé Sévigné | Rennes | France |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Locoregional Analgesia by Femoral Triangle Catheterization | Ropivacaine: Locoregional analgesia by femoral triangle catheterization |
| BG001 | Tissue Infiltration | Ropivacaine: Tissue infiltration |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Missing data | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| BMI | Median | Inter-Quartile Range | kg/m² |
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| Rest Pain Assessment Scale | Self-assessment scale to quantify the patient's pain on a virtual scale from 0 (no pain) to 10 (maximum pain imaginable) | Median | Inter-Quartile Range | units on a scale |
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| Walking Pain Assessment Scale | Self-assessment scale to quantify the patient's pain on a virtual scale from 0 (no pain) to 10 (maximum pain imaginable) | Median | Inter-Quartile Range | units on a scale |
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| Douleur Neuropathique en 4 questions | The DN4 (Douleur Neuropathique en 4 questions) is a validated clinician-administered screening tool for neuropathic pain. It comprises 10 items, each scored 0 (absent) or 1 (present). The total score is calculated by summing all item scores and ranges from 0 to 10. Higher scores indicate a greater likelihood of neuropathic pain (worse outcome), while lower scores indicate a lower likelihood (better outcome). A total score of ≥4/10 indicates likely neuropathic pain. The DN4 is generally interpreted using the total score; separate subscale scores are not typically calculated or reported. | Median | Inter-Quartile Range | units on a scale |
| ||||||||||||||
| WOMAC Score | The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a validated patient-reported questionnaire assessing pain, stiffness, and physical function in osteoarthritis. Higher scores indicate worse symptoms and functional impairment. Range : 0 -100 | Median | Inter-Quartile Range | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Walking Pain Assessment Scale | Self-assessment scale to quantify the patient's pain on a virtual scale from 0 (no pain) to 10 (maximum pain imaginable). Measure is positive when score is >= 4 | Patient is count when EN at walking is greater or equal to 4 | Posted | Count of Participants | Participants | Three months from the intervention |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Locoregional Analgesia by Femoral Triangle Catheterization | Ropivacaine: Locoregional analgesia by femoral triangle catheterization | 0 | 143 | 0 | 143 | 0 | 143 |
| EG001 | Tissue Infiltration | Ropivacaine: Tissue infiltration | 0 | 144 | 0 | 144 | 0 | 144 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jérôme GUILLEY | CHD VENDEE | 02 51 44 65 72 | +33 | jerome.guilley@ght85.fr |
| Sep 3, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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