A multicentre, non-interventional, prospective observational study of the use of the sufentanil sublingual tablet system (Zalviso®) for the management of acute postoperative pain in a hospital setting (ZAS)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective observational study

Study drug and medical condition

• Medical condition to be studied:
  Pain

  Hospitalisation

  Postoperative care

Population studied

• Short description of the study population:
  Patients with postoperative moderate to severe acute pain who have received Zalviso®.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Renal impaired
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  The demographic and surgical characteristics of patient-controlled analgesia with Zalviso® will be studied in in-patients with acute postoperative pain.
• Outcomes:
  The primary study endpoint is the “Patient Global Assessment of the Method of Pain Control (PGA)” questionnaire. - Course of pain on a Numeric Rating Scale (NRS) of 0-10- Quality of sleep.- Global Assessment of the method of pain control by Health Professionals (HPGA).- Safety and tolerability and "Nurse Ease of Care Questionnaires" (EoC).- Results derived from the EQ-5D will be summarized descriptively by individual parameter and summary scores.
• Data analysis plan:
  Descriptive statistical analyses will be performed on all data collected from patients enrolled.Descriptive statistics of all endpoints will include specifically but not exclusively arithmetic mean, medians, standard deviations, minimum, maximum, proportions, frequency counts, 25th and 75th percentiles, and 95% confidence intervals of select point estimates.The primary parameters analyzed will be the pain intensity profile as well as the ease of use of the Zalviso device from the data collected in the 3 domains of the Nurse & Physical Therapist Ease of Care (EOC) Questionnaire.For the Nurse EoC questionnaire, descriptive statistics will be presented for all single items, the three subscores and the total score. Tolerability will be reported in the form of incidence of adverse drug reactions, based on MedDRA coded preferred terms.The same analysis will be done on Incident or Risk of Incident with Medical Device.