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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03355352

Enrollment

100

Registered

2017-11-28

Start date

2017-11-01

Completion date

2018-12-01

Last updated

2017-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesic Quality, Mobility

Keywords

Zalviso, sufentanyl, PCA, Dipidolor

Brief summary

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.

Interventions

DRUGSufentanil

Sufentail sublingual 15ug nanopills

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
analgesic quality	1 year	Recording of the analgesic quality measured by the request of more analgesic postoperative while being treated with the conventional PCA or the Zalviso system.
mobility	1 year	Recording of the patients mobility postoperative while being treated with the conventional PCA or the Zalviso system.

Secondary

Measure	Time frame	Description
medical cost efficiency	1 year	Comparison of the cost efficiency of both systems

Countries

Germany

Contacts

Primary ContactBarbara Schlisio, Dr. med.

barbara.schlisio@med.uni-tuebingen.de07071/2985612

Backup ContactFabian Kreß

Fabian.kress@student.uni-tuebingen.de

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026