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 (ZEUS - Germany)

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

• Anatomical Therapeutic Chemical (ATC) code:
  (N01AH03) sufentanil

  sufentanil
• Medical condition to be studied:
  Pain

  Hospitalisation

  Postoperative care

Population studied

• Short description of the study population:
  Patients with acute postoperative pain undergoing a broad variety of surgery types 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 & surgical characteristics of patient-controlled analgesia with Zalviso® will be studied in in-patients with acute postoperative pain. Key parameters: - Pain intensity - Max pain intensity- Quality of sleep- Postoperative mobility- Patient Global Assessment of the Method of Pain Control- Nurse & Physical Therapist Ease of Care Questionnaire for device performance.
• Outcomes:
  Patient Global Assessment of the Method of Pain Control.Worst pain. Quality of sleep. Concomitant medication.Safety using safety reporting forms for risk assessment endpoints. Nurse & Physical Therapist Ease of Care (EOC) Questionnaire.Device performance.
• Data analysis plan:
  Descriptive statistical analyses will be performed on all data collected from patients enrolled. An exploratory data analysis will be performed. Continous variables will be analyzed which 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 following parameters will be analyzed: - demographic data- pain intensity profile - quality of sleep, - postoperative mobility- Patient Global Assessment of the Method of Pain Control- Nurse & Physical Therapist Ease of Care (EOC) Questionnaire for device performance).Tolerability will be reported in the form of incidence of adverse drug reactions, based on MedDRA coded preferred Terms.