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

• Conditions: Mobility; Analgesic Quality
• Interventions: Drug: Sufentanil

• Registration Number: NCT03355352
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-11
• Study Start: 2017-11-01
• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-11-27
• Last Update Submitted: 2017-11-27
• Study First Posted: 2017-11-28
• Last Update Posted: 2017-11-28
• Primary Completion: 2018-08-01
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with Zalviso	Sufentanil	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
medical cost efficiency	1 year	Comparison of the cost efficiency of both systems

Trial Locations

Locations (1)

University Tuebingen, clinic of anästhesiology and intensiv care; 🇩🇪 Tuebingen, Germany