Medico-economic Evaluation of Sublingual PCA (Zalviso) Versus Oxycodone-PCA in the Management of Postoperative Pain.

Study Overview
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Brief Summary
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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.

Official Title
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Medico-economic Evaluation of Sublingual PCA (Zalviso) Versus Oxycodone-PCA in the Management of Postoperative Pain. ''MEZO''

Conditions
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Analgesia

Intervention / Treatment
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* Procedure: Patient Controlled Analgesia (PCA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults patients able to express consent signed written informed consent form patient covered by national health insurance patient undergoing total knee arthroplasty and requiring postoperative analgesia with the use of a PCA (patient controlled analgesia) Exclusion Criteria: minors obstruction to participate patient non covered by national health insurance patient requiring a stay in intensive care immediately after the surgery patient unable to use a PCA a assessed by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sublingual Patient Controlled Analgesia (PCA)<br>Sufentanil Sublingual Patient Controlled Analgesia (PCA) | Procedure: Patient Controlled Analgesia (PCA)<br>* Patient Controlled Analgesia (PCA)<br>|
| Active Comparator: Intravenous Patient Controlled Analgesia (PCA)<br>Oxycodone Intravenous Patient Controlled Analgesia (PCA) | Procedure: Patient Controlled Analgesia (PCA)<br>* Patient Controlled Analgesia (PCA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sublingual Patient Controlled Analgesia (PCA), Intravenous Patient Controlled Analgesia (PCA), Patient Controlled Analgesia (PCA)