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

Not Applicable

Completed

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

• Registration Number: NCT03882320
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-20
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sublingual Patient Controlled Analgesia (PCA)	Patient Controlled Analgesia (PCA)	Sufentanil Sublingual Patient Controlled Analgesia (PCA)
Intravenous Patient Controlled Analgesia (PCA)	Patient Controlled Analgesia (PCA)	Oxycodone Intravenous Patient Controlled Analgesia (PCA)

Primary Outcome Measures

Name	Time	Method
Costs of each Intravenous Patient Controlled Analgesia (PCA)	until 72 hours after knee arthroplasty	Comparison of costs associated with the use of sublingual PCA to those of intravenous PCA

Secondary Outcome Measures

Name	Time	Method
Length of hospitalization	until 72 hours after knee arthroplasty	Length of hospitalization
Efficiency of acute postoperative pain management	until 72 hours after knee arthroplasty	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	until 72 hours after knee arthroplasty	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)

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, Picardie, France