Sublingual Sufentanil PCA Usability for Postoperative Pain (Zalviso® System)

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.

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