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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zalviso Device | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours after use of Zalviso |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours after use of Zalviso |
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Inclusion Criteria:
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Patients with major functional surgery associated with moderate-to severe postoperative pain in the enhanced recovery settings.
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric AUBRUN, MD, PhD | Service d'Anesthésie Réanimation - Hôpital de la Croix-Rousse - Lyon | Principal Investigator |
| Mikhail DZIADZKO, MD | Service d'Anesthésie Réanimation - Hôpital de la Croix-Rousse - Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Croix Rousse - Service d'Anesthésie-Réanimation | Lyon | 69004 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33880939 | Derived | 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. |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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