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

NCT ID: NCT03355352

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-12-01

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.

Detailed Description

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Conditions

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Analgesic Quality Mobility

Keywords

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Zalviso sufentanyl PCA Dipidolor

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients treated with conventional i.v. PCA

No interventions assigned to this group

Patients treated with Zalviso

Sufentanil

Intervention Type DRUG

Sufentail sublingual 15ug nanopills

Interventions

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Sufentanil

Sufentail sublingual 15ug nanopills

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Tuebingen, clinic of anästhesiology and intensiv care

Tübingen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Barbara Schlisio, Dr. med.

Role: CONTACT

Phone: 07071/2985612

Email: [email protected]

Fabian Kreß

Role: CONTACT

Email: [email protected]

Facility Contacts

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Barabar Schlisio, Dr. med

Role: primary

Other Identifiers

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277/2017BO1

Identifier Type: -

Identifier Source: org_study_id