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

Analgesia Clinical Trial

— MEZO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03882320
• Other study ID #: PI2018_843_0044
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Pain, Postoperative

Intervention

Procedure:
• Patient Controlled Analgesia (PCA)
Patient Controlled Analgesia (PCA)

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Pitié-Salpêtrière Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of hospitalization	Length of hospitalization	until 72 hours after knee arthroplasty
Secondary	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
Secondary	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