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Completed

NCT Number: NCT03882320

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Controlled Analgesia (PCA)

Procedure

Patient Controlled Analgesia (PCA)

Primary outcomes

  1. Costs of each Intravenous Patient Controlled Analgesia (PCA)

    Time frame: until 72 hours after knee arthroplasty

    Comparison of costs associated with the use of sublingual PCA to those of intravenous PCA

Secondary outcomes

  1. Length of hospitalization

    Time frame: until 72 hours after knee arthroplasty

    Length of hospitalization

  2. Efficiency of acute postoperative pain management

    Time frame: 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).

  3. Global satisfaction of the patient

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Pitié-Salpêtrière Hospital

Registry information

Official study title

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

Acronym: MEZO

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 20, 2019
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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