Clinical trial NCT03373851: Sublingual Sufentanil PCA Usability for Postoperative Pain (Zalviso® System)
Official title: Usability and Satisfaction Evaluation of Sufentanil Sublingual Patient-Controlled Analgesia After Elective Surgery With Moderate-to-Severe Postoperative Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Surgery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with major functional surgery associated with moderate-to severe postoperative pain in the enhanced recovery settings.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: System Usability Score
timeFrame: 72 hours after use of Zalviso
Secondary outcomes:
measure: Satisfaction Score
timeFrame: 72 hours after use of Zalviso
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse - Service d'Anesthésie-Réanimation
Study officials:
affiliation: Service d'Anesthésie Réanimation - Hôpital de la Croix-Rousse - Lyon
name: Frédéric AUBRUN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service d'Anesthésie Réanimation - Hôpital de la Croix-Rousse - Lyon
name: Mikhail DZIADZKO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.