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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03882320
Acronym
MEZO
Enrollment
60
Registered
2019-03-20
Start date
2019-03-01
Completion date
2021-03-01
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia

Keywords

Sublingual Patient Controlled Analgesia (PCA), Intravenous Patient Controlled Analgesia (PCA), Patient Controlled Analgesia (PCA)

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.

Interventions

Patient Controlled Analgesia (PCA)

Sponsors

Pitié-Salpêtrière Hospital
CollaboratorOTHER
Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Costs of each Intravenous Patient Controlled Analgesia (PCA)until 72 hours after knee arthroplastyComparison of costs associated with the use of sublingual PCA to those of intravenous PCA

Secondary

MeasureTime frameDescription
Length of hospitalizationuntil 72 hours after knee arthroplastyLength of hospitalization
Efficiency of acute postoperative pain managementuntil 72 hours after knee arthroplastyPain 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 patientuntil 72 hours after knee arthroplastyGlobal 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026