AnalgesiaMEZONCT03882320
Medico-economic Evaluation of Sublingual PCA (Zalviso) Versus Oxycodone-PCA in the Management of Postoperative Pain.
A study of Analgesia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medico-economic Evaluation of Sublingual PCA (Zalviso) Versus Oxycodone-PCA in the Management of Postoperative Pain. ''MEZO''
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.
- Conditions
- Analgesia
- Being tested
- Patient Controlled Analgesia (PCA)
- Keywords
- Sublingual Patient Controlled Analgesia (PCA), Intravenous Patient Controlled Analgesia (PCA), Patient Controlled Analgesia (PCA)
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Controlled Analgesia (PCA)Procedure or surgery
Patient Controlled Analgesia (PCA)
| Study group | Role | What they receive |
|---|---|---|
| Sublingual Patient Controlled Analgesia (PCA) | Experimental | Sufentanil Sublingual Patient Controlled Analgesia (PCA) Receives: Procedure: Patient Controlled Analgesia (PCA) |
| Intravenous Patient Controlled Analgesia (PCA) | Active comparator | Oxycodone Intravenous Patient Controlled Analgesia (PCA) Receives: Procedure: Patient Controlled Analgesia (PCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Costs of each Intravenous Patient Controlled Analgesia (PCA)
Comparison of costs associated with the use of sublingual PCA to those of intravenous PCA
Measured: until 72 hours after knee arthroplasty
Secondary outcomes (3)
Length of hospitalization
Length of hospitalization
Measured: until 72 hours after knee arthroplasty
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).
Measured: until 72 hours after knee arthroplasty
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)
Measured: until 72 hours after knee arthroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start1 Mar 2019
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Pitié-Salpêtrière Hospital
- Responsible party
- Sponsor
- Investigators
- Alexandre NTOUBA, MD, Principal investigator, CHU AmiensSandrine THOMAS SORIOT, MD, Principal investigator, CHU AmiensPierre CORIAT, Pr, Principal investigator, Pitié-Salpêtrière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882320
- Sponsor's protocol ID
- PI2018_843_0044
- Acronym
- MEZO
- Status last verified
- May 2023
- First submitted
- 15 Mar 2019
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Evaluation of Sublingual PCA (Zalviso) Versus Oxycodone-PCA in the Management of Postoperative Pain. ''MEZO''
- ClinicalTrials.gov ID
- NCT03882320
- Acronym / sponsor ID
- MEZO / PI2018_843_0044
- Conditions
- Analgesia
- Keywords
- Sublingual Patient Controlled Analgesia (PCA), Intravenous Patient Controlled Analgesia (PCA), Patient Controlled Analgesia (PCA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Pitié-Salpêtrière Hospital
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublingual Patient Controlled Analgesia (PCA) | Experimental | Procedure: Patient Controlled Analgesia (PCA)Sufentanil Sublingual Patient Controlled Analgesia (PCA) |
| Intravenous Patient Controlled Analgesia (PCA) | Active comparator | Procedure: Patient Controlled Analgesia (PCA)Oxycodone Intravenous Patient Controlled Analgesia (PCA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Controlled Analgesia (PCA)Patient Controlled Analgesia (PCA) | Procedure or surgery | Intravenous Patient Controlled Analgesia (PCA), Sublingual Patient Controlled Analgesia (PCA) |
Primary outcome
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
3 secondary outcomes
Length of hospitalization
Time frame: until 72 hours after knee arthroplasty
Efficiency of acute postoperative pain management
Time frame: until 72 hours after knee arthroplasty
Global satisfaction of the patient
Time frame: until 72 hours after knee arthroplasty
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre NTOUBA, MD principal investigator
CHU Amiens
Sandrine THOMAS SORIOT, MD principal investigator
CHU Amiens
Pierre CORIAT, Pr principal investigator
Pitié-Salpêtrière Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Analgesia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Costs of each Intravenous Patient Controlled Analgesia (PCA) (time frame: until 72 hours after knee arthroplasty). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.