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| Name | Class |
|---|---|
| Pitié-Salpêtrière Hospital | OTHER |
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More than 230 million surgical operations are been realized all over the world every year. A surgical intervention can cause postoperative acute pain. The management of postoperative acute pain is multimodal and the use of patient-controlled analgesia (PCA) is often a part of this Pain-Management.
Intravenous PCA has established itself as a therapeutic concept and constitutes the reference treatment for the management of postoperative acute pain for the first 48 hours. The PCA offers patients autonomy in managing their pain with the intravenous delivery of morphine on demand.
Since 2017 PCA Zalviso is marketed. It allows the sublingual administration of sufentanil and it does not require venous access. It seems interesting to allow the early rehabilitation of patients who are no longer limited in their movements by an infusion. However, its acquisition cost appears to be higher than that of the intravenous PCA. In order to verify this hypothesis, the investigators propose to compare the set of costs associated with the use of sublingual PCA with those of intravenous PCA in the management of acute postoperative pain (less than 72 hours) in the context of patients benefiting from the placement of a total knee arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sublingual Patient Controlled Analgesia (PCA) | Experimental | Sufentanil Sublingual Patient Controlled Analgesia (PCA) |
|
| Intravenous Patient Controlled Analgesia (PCA) | Active Comparator | Oxycodone Intravenous Patient Controlled Analgesia (PCA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Controlled Analgesia (PCA) | Procedure | Patient Controlled Analgesia (PCA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Costs of each Intravenous Patient Controlled Analgesia (PCA) | Comparison of costs associated with the use of sublingual PCA to those of intravenous PCA | until 72 hours after knee arthroplasty |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospitalization | Length of hospitalization | until 72 hours after knee arthroplasty |
| Efficiency of acute postoperative pain management | Pain intensity is measured with numeric score (scale 0 to 10) (10 is the highest pain intensity; 0 is the score for the absence of pain). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre NTOUBA, MD | CHU Amiens | Principal Investigator |
| Sandrine THOMAS SORIOT, MD | CHU Amiens | Principal Investigator |
| Pierre CORIAT, Pr | Pitié-Salpêtrière Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Picardie | Amiens | Picardie | 80054 | France |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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| until 72 hours after knee arthroplasty |
| Global satisfaction of the patient | Global satisfaction of the patient is measured with " Echelle Visuelle Analogique" EVA score (scale 0 to 10; score 0= no pain; score 10 = pain with the highest intensity) | until 72 hours after knee arthroplasty |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |