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

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Procedure: Patient Controlled Analgesia (PCA)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandre NTOUBA, MD; Phone Number: (33)322087947; Email: ntouba.alexandre@chu-amiens.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • CHU Amiens Picardie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 20, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Patient Controlled Analgesia (PCA); Sublingual Patient Controlled Analgesia (PCA); Intravenous Patient Controlled Analgesia (PCA)
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: PI2018_843_0044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No