TraumaUSE-SSPCNCT03373851
Sublingual Sufentanil PCA Usability for Postoperative Pain (Zalviso® System)
An observational study of Trauma and Surgery, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Intravenous patient-controlled analgesia (iv-PCA) is the gold standard for the treatment of moderate to severe postoperative pain. It is used in more than 20% of cases after major surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Zalviso Device
- Type of treatment
- Medical device
- How many people
- 119 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2018to 24 May 2019
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients with major functional surgery associated with moderate-to severe postoperative pain in the enhanced recovery settings.
Who may be able to join
- Adults
- 16 <BMI <40
- ASA I and II
- Patient with traumatic functional surgery - Knee and hip arthroplasty, shoulder surgery, tibial osteotomy / femoral osteotomy; or plastic and aesthetic surgery with volume correction of more than 30% of body surface area (bodylift), DIEP, DLA.
- Patient who should theoretically benefit of a postop self-controlled analgesia of morphine for 72 hours on average
- Patient informed of the modalities of the study with delivery of an information leaflet
- Free and informed consent collection
Who cannot join
- Patient refusing to participate in the study
- Language barrier
- Hypersensitivity to sufentanil,
- Respiratory failure
- Renal insufficiency (GFR <30 ml / min)
- Epilepsy not controlled by treatment
Show all 12Show fewer
- Psychic and mental illness not controlled by treatment
- Hepatocellular insufficiency (TP <50%)
- Heart failure (LVEF <50%)
- patients with chronic pain, treated with level 3 analgesic and / or already treated for neuropathic pain
- Drug-addicted patients
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital de la Croix Rousse - Service d'Anesthésie-Réanimation
Lyon, 69004
About this study
Official title: Usability and Satisfaction Evaluation of Sufentanil Sublingual Patient-Controlled Analgesia After Elective Surgery With Moderate-to-Severe Postoperative Pain
Intravenous patient-controlled analgesia (iv-PCA) is the gold standard for the treatment of moderate to severe postoperative pain. It is used in more than 20% of cases after major surgery. Well known disadvantages of this method include the need of intravenous line (invasive, infection risk), the risk of pump programming error, possible delay for ambulation/barrier for enhanced rehabilitation programmes, and time/resource demanding (the need of preparation and installation). Sublingual sufentanil based PCA (Zalviso®) addresses cited issues. The safety and analgesia efficiency of this system is well described. However, the usability and satisfaction of Zalviso® varies depending on clinical settings. The goal of this study is to evaluate the usability and satisfaction of patients, nurses, and physical therapists using Zalviso® System during the first 72 hours in the settings of Enhanced Recovery After Surgery protocol after major interventions associated with moderate to severe postoperative pain.
- Being tested
- Zalviso Device
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zalviso DeviceDevice
The Zalviso device will be provided immediately before the Post anesthesia care unit (PACU) discharge. Patients will be queried every day during three postoperative days for the ability to use the device, their satisfaction, the level of pain, and the incidence of side effects. There will be no changes in usual care.
In the end of this study ward nurses carrying Zalviso patients will be asked to provide their usability and satisfaction evaluation for Zalviso device management. Physical therapist will be asked to provide their satisfaction regarding patients' ability to follow physical therapy program.
| Study group | Role | What they receive |
|---|---|---|
| Zalviso | Patient willing to participate to the study, and scheduled for major functional surgery (arthroplasty, valgisation osteotomy, DIEP flap surgery, total body lift procedures) will be consented to use the Zalviso device in postoperative period as a main analgesia method. Receives: Device: Zalviso Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Score
A 10 items Licket type System Usability Score will be used in patients with ZALVISO® analgesia and in carrying ward nurses 72 hours the surgery per each case.
Measured: 72 hours after use of Zalviso
Secondary outcomes (1)
Satisfaction Score
100 points (0 - no satisfaction; 100 - entire satisfaction) satisfaction score will be used in physical therapist 72 hours after the surgery per each case.
Measured: 72 hours after use of Zalviso
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start25 Jun 2018
- Primary completion24 May 2019
- Study completion24 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric AUBRUN, MD, PhD, Principal investigator, Service d'Anesthésie Réanimation - Hôpital de la Croix-Rousse - LyonMikhail DZIADZKO, MD, Principal investigator, Service d'Anesthésie Réanimation - Hôpital de la Croix-Rousse - Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373851
- Sponsor's protocol ID
- 69HCL17_0511
- Acronym
- USE-SSPC
- Status last verified
- Sep 2022
- First submitted
- 6 Dec 2017
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amson H, Lasselin P, Naegels B, Pardey Bracho GF, Aubrun F, Dziadzko M. Usability evaluation of sufentanil sublingual tablet analgesia in patients following Enhanced Recovery After Surgery. J Comp Eff Res. 2021 Jun;10(9):743-750. doi: 10.2217/cer-2020-0239. Epub 2021 Apr 21.
PubMed 33880939
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability and Satisfaction Evaluation of Sufentanil Sublingual Patient-Controlled Analgesia After Elective Surgery With Moderate-to-Severe Postoperative Pain
- ClinicalTrials.gov ID
- NCT03373851
- Acronym / sponsor ID
- USE-SSPC / 69HCL17_0511
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 24 May 2019 (actual)
- First posted
- 14 Dec 2017 (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.
Intravenous patient-controlled analgesia (iv-PCA) is the gold standard for the treatment of moderate to severe postoperative pain. It is used in more than 20% of cases after major surgery. Well known disadvantages of this method include the need of intravenous line (invasive, infection risk), the risk of pump programming error, possible delay for ambulation/barrier for enhanced rehabilitation programmes, and time/resource demanding (the need of preparation and installation). Sublingual sufentanil based PCA (Zalviso®) addresses cited issues. The safety and analgesia efficiency of this system is well described. However, the usability and satisfaction of Zalviso® varies depending on clinical settings. The goal of this study is to evaluate the usability and satisfaction of patients, nurses, and physical therapists using Zalviso® System during the first 72 hours in the settings of Enhanced Recovery After Surgery protocol after major interventions associated with moderate to severe postoperative pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zalviso | – | Device: Zalviso DevicePatient willing to participate to the study, and scheduled for major functional surgery (arthroplasty, valgisation osteotomy, DIEP flap surgery, total body lift procedures) will be consented to use the Zalviso device in postoperative period as a main analgesia method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with major functional surgery associated with moderate-to severe postoperative pain in the enhanced recovery settings.
Key inclusion criteria (7 listed)
- Adults
- 16 <BMI <40
- ASA I and II
- Patient with traumatic functional surgery - Knee and hip arthroplasty, shoulder surgery, tibial osteotomy / femoral osteotomy; or plastic and aesthetic surgery with volume correction of more than 30% of body surface area (bodylift), DIEP, DLA.
- Patient who should theoretically benefit of a postop self-controlled analgesia of morphine for 72 hours on average
Key exclusion criteria (12 listed)
- Patient refusing to participate in the study
- Language barrier
- Hypersensitivity to sufentanil,
- Respiratory failure
- Renal insufficiency (GFR <30 ml / min)
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 |
|---|---|---|
| Zalviso DeviceThe Zalviso device will be provided immediately before the Post anesthesia care unit (PACU) discharge. Patients will be queried every day during three postoperative days for the ability to use the device, their satisfaction, the level of pain, and the incidence of side effects. There will be no changes in usual care. In the end of this study ward nurses carrying Zalviso patients will be asked to provide their usability and satisfaction evaluation for Zalviso device management. Physical therapist will be asked to provide their satisfaction regarding patients' ability to follow physical therapy program. | Device | Zalviso |
Primary outcome
System Usability Score
Time frame: 72 hours after use of Zalviso
A 10 items Licket type System Usability Score will be used in patients with ZALVISO® analgesia and in carrying ward nurses 72 hours the surgery per each case.
1 secondary outcome
Satisfaction Score
Time frame: 72 hours after use of Zalviso
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 2 Sep 2022.
- Derived from this study: PubMed 33880939Amson H, Lasselin P, Naegels B, Pardey Bracho GF, Aubrun F, Dziadzko M. Usability evaluation of sufentanil sublingual tablet analgesia in patients following Enhanced Recovery After Surgery. J Comp Eff Res. 2021 Jun;10(9):743-750. doi: 10.2217/cer-2020-0239. Epub 2021 Apr 21.
- 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.
Frédéric AUBRUN, MD, PhD principal investigator
Service d'Anesthésie Réanimation - Hôpital de la Croix-Rousse - Lyon
Mikhail DZIADZKO, MD principal investigator
Service d'Anesthésie Réanimation - Hôpital de la Croix-Rousse - Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Surgery, run by Hospices Civils de Lyon 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 7 inclusion and 12 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 2 Sep 2022. 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?
System Usability Score (time frame: 72 hours after use of Zalviso). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03373851, which also lists 1 linked publication.
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 2 Sep 2022.