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

Primary Purpose

Analgesia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patient Controlled Analgesia (PCA)
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia focused on measuring Sublingual Patient Controlled Analgesia (PCA), Intravenous Patient Controlled Analgesia (PCA), Patient Controlled Analgesia (PCA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens Picardie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sublingual Patient Controlled Analgesia (PCA)

Intravenous Patient Controlled Analgesia (PCA)

Arm Description

Sufentanil Sublingual Patient Controlled Analgesia (PCA)

Oxycodone Intravenous Patient Controlled Analgesia (PCA)

Outcomes

Primary Outcome Measures

Costs of each Intravenous Patient Controlled Analgesia (PCA)
Comparison of costs associated with the use of sublingual PCA to those of intravenous PCA

Secondary Outcome Measures

Length of hospitalization
Length of hospitalization
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).
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)

Full Information

First Posted
March 15, 2019
Last Updated
May 9, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Pitié-Salpêtrière Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03882320
Brief Title
Medico-economic Evaluation of Sublingual PCA (Zalviso) Versus Oxycodone-PCA in the Management of Postoperative Pain.
Acronym
MEZO
Official Title
Medico-economic Evaluation of Sublingual PCA (Zalviso) Versus Oxycodone-PCA in the Management of Postoperative Pain. ''MEZO''
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Pitié-Salpêtrière Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
Keywords
Sublingual Patient Controlled Analgesia (PCA), Intravenous Patient Controlled Analgesia (PCA), Patient Controlled Analgesia (PCA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sublingual Patient Controlled Analgesia (PCA)
Arm Type
Experimental
Arm Description
Sufentanil Sublingual Patient Controlled Analgesia (PCA)
Arm Title
Intravenous Patient Controlled Analgesia (PCA)
Arm Type
Active Comparator
Arm Description
Oxycodone Intravenous Patient Controlled Analgesia (PCA)
Intervention Type
Procedure
Intervention Name(s)
Patient Controlled Analgesia (PCA)
Intervention Description
Patient Controlled Analgesia (PCA)
Primary Outcome Measure Information:
Title
Costs of each Intravenous Patient Controlled Analgesia (PCA)
Description
Comparison of costs associated with the use of sublingual PCA to those of intravenous PCA
Time Frame
until 72 hours after knee arthroplasty
Secondary Outcome Measure Information:
Title
Length of hospitalization
Description
Length of hospitalization
Time Frame
until 72 hours after knee arthroplasty
Title
Efficiency of acute postoperative pain management
Description
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).
Time Frame
until 72 hours after knee arthroplasty
Title
Global satisfaction of the patient
Description
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)
Time Frame
until 72 hours after knee arthroplasty

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre NTOUBA, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandrine THOMAS SORIOT, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre CORIAT, Pr
Organizational Affiliation
Pitié-Salpêtrière Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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