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

Study Overview
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Brief Summary
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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.

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

Conditions
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Analgesic Quality, Mobility

Intervention / Treatment
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* Drug: Sufentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated with conventional i.v. PCA<br> | |
| Patients treated with Zalviso<br> | Drug: Sufentanil<br>* Sufentail sublingual 15ug nanopills<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| medical cost efficiency | Comparison of the cost efficiency of both systems | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zalviso, sufentanyl, PCA, Dipidolor