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

Overview

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.

Full Title of Study: “Medico-economic Evaluation of Sublingual PCA (Zalviso) Versus Oxycodone-PCA in the Management of Postoperative Pain. ”MEZO””

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 1, 2021

Interventions

  • Procedure: Patient Controlled Analgesia (PCA)
    • Patient Controlled Analgesia (PCA)

Arms, Groups and Cohorts

  • Experimental: Sublingual Patient Controlled Analgesia (PCA)
    • Sufentanil Sublingual Patient Controlled Analgesia (PCA)
  • Active Comparator: Intravenous Patient Controlled Analgesia (PCA)
    • Oxycodone Intravenous Patient Controlled Analgesia (PCA)

Clinical Trial Outcome Measures

Primary Measures

  • Costs of each Intravenous Patient Controlled Analgesia (PCA)
    • Time Frame: until 72 hours after knee arthroplasty
    • Comparison of costs associated with the use of sublingual PCA to those of intravenous PCA

Secondary Measures

  • Length of hospitalization
    • Time Frame: until 72 hours after knee arthroplasty
    • Length of hospitalization
  • Efficiency of acute postoperative pain management
    • Time Frame: until 72 hours after knee arthroplasty
    • 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).
  • Global satisfaction of the patient
    • Time Frame: until 72 hours after knee arthroplasty
    • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire, Amiens
  • Collaborator
    • Pitié-Salpêtrière Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alexandre NTOUBA, MD, Principal Investigator, CHU Amiens
    • Sandrine THOMAS SORIOT, MD, Principal Investigator, CHU Amiens
    • Pierre CORIAT, Pr, Principal Investigator, Pitié-Salpêtrière Hospital

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