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

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ClinicalTrials.gov Identifier: NCT03882320
Recruitment Status : Not yet recruiting
First Posted : March 20, 2019
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
Pitié-Salpêtrière Hospital
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Analgesia Procedure: Patient Controlled Analgesia (PCA) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medico-economic Evaluation of Sublingual PCA (Zalviso) Versus Oxycodone-PCA in the Management of Postoperative Pain. ''MEZO''
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sublingual Patient Controlled Analgesia (PCA)
Sufentanil Sublingual Patient Controlled Analgesia (PCA)
Procedure: Patient Controlled Analgesia (PCA)
Patient Controlled Analgesia (PCA)

Active Comparator: Intravenous Patient Controlled Analgesia (PCA)
Oxycodone Intravenous Patient Controlled Analgesia (PCA)
Procedure: Patient Controlled Analgesia (PCA)
Patient Controlled Analgesia (PCA)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Length of hospitalization [ Time Frame: until 72 hours after knee arthroplasty ]
    Length of hospitalization

  2. 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).

  3. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882320


Contacts
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Contact: Alexandre NTOUBA, MD (33)322087947 ntouba.alexandre@chu-amiens.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Pitié-Salpêtrière Hospital
Investigators
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Principal Investigator: Alexandre NTOUBA, MD CHU Amiens
Principal Investigator: Sandrine THOMAS SORIOT, MD CHU Amiens
Principal Investigator: Pierre CORIAT, Pr Pitié-Salpêtrière Hospital

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03882320     History of Changes
Other Study ID Numbers: PI2018_843_0044
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Sublingual Patient Controlled Analgesia (PCA)
Intravenous Patient Controlled Analgesia (PCA)
Patient Controlled Analgesia (PCA)

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents