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Observational Study of Analgesia and Cost-efficiency of Analgetic Medication Pumps (Zalviso and PCA-syringe Pump (PCA=Patient Controlled Analgesia)) After Urogenital Intervention at the Clinical Daily Routine

U

University Hospital Tuebingen

Status

Unknown

Conditions

Mobility
Analgesic Quality

Treatments

Drug: Sufentanil

Study type

Observational

Funder types

Other

Identifiers

NCT03355352
277/2017BO1

Details and patient eligibility

About

The observational study will check if there is a difference in the postoperative care of patients with urogenital intervention while using the standard PCA-syringe pump or using the Zalviso sufentanyl sublingual analgetic system.

The study will exactly examine, using questionaire for the patient, the medical stuff (nurses and anesthesiologist) the difference in the analgetic quality, the difference of the patients' mobility while being treated with one of the analgetic system and if there is a difference in the cost-efficiency.

We want to examine 50 Patients in each group. The studies should be finished in about one year.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients after urological interventions with no indication of an periduralanästesia
  • Patients compliant for a PCA system, and complied with the analysis of their data

Exclusion criteria

  • F03 dementia
  • F10.2 dependence syndrome alcohol
  • F11.2 dependence syndrome opioids
  • F12.2 dependence syndrome cannabinoids
  • F13.2 dependence syndrome sedatives and hypnotics
  • F14.2 dependence syndrome cocaine
  • F15.2 dependence syndrome coffin
  • F.16.2 dependence syndrome hallucinogens
  • F22 schizophrenia
  • F41.1 generalized anxiety disorder

Trial design

100 participants in 2 patient groups

Patients treated with conventional i.v. PCA
Patients treated with Zalviso
Treatment:
Drug: Sufentanil

Trial contacts and locations

1

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Central trial contact

Barbara Schlisio, Dr. med.; Fabian Kreß

Data sourced from clinicaltrials.gov

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