Clinical trial NCT03882320: Medico-economic Evaluation of Sublingual PCA (Zalviso) Versus Oxycodone-PCA in the Management of Postoperative Pain.
Official title: Medico-economic Evaluation of Sublingual PCA (Zalviso) Versus Oxycodone-PCA in the Management of Postoperative Pain. ''MEZO''
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: Sublingual Patient Controlled Analgesia (PCA)
Intravenous Patient Controlled Analgesia (PCA)
Patient Controlled Analgesia (PCA)
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Pitié-Salpêtrière Hospital
First posted: 2019-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Costs of each Intravenous Patient Controlled Analgesia (PCA)
timeFrame: until 72 hours after knee arthroplasty
Secondary outcomes:
measure: Length of hospitalization
timeFrame: until 72 hours after knee arthroplasty
measure: Efficiency of acute postoperative pain management
timeFrame: until 72 hours after knee arthroplasty
measure: Global satisfaction of the patient
timeFrame: until 72 hours after knee arthroplasty
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
affiliation: CHU Amiens
name: Alexandre NTOUBA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Sandrine THOMAS SORIOT, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pitié-Salpêtrière Hospital
name: Pierre CORIAT, Pr
role: PRINCIPAL_INVESTIGATOR
References: