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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

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ClinicalTrials.gov Identifier: NCT03355352
Recruitment Status : Unknown
Verified November 2017 by University Hospital Tuebingen.
Recruitment status was:  Recruiting
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Study Description
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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.


Condition or disease Intervention/treatment
Analgesic Quality Mobility Drug: Sufentanil

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Observational Study of Analgesia and Cost-efficiency of Analgetic Medication Pumps (Zalviso and PCA-syringe Pump) After Urogenital Intervention at the Clinical Daily Routine
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients treated with conventional i.v. PCA
Patients treated with Zalviso Drug: Sufentanil
Sufentail sublingual 15ug nanopills


Outcome Measures
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Primary Outcome Measures :
  1. analgesic quality [ Time Frame: 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.

  2. mobility [ Time Frame: 1 year ]
    Recording of the patients mobility postoperative while being treated with the conventional PCA or the Zalviso system.


Secondary Outcome Measures :
  1. medical cost efficiency [ Time Frame: 1 year ]
    Comparison of the cost efficiency of both systems


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients at the teaching hospital of university tuebingen which get an surgical urological intervention and which correspond with the inclusion criteria.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355352


Contacts
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Contact: Barbara Schlisio, Dr. med. 07071/2985612 barbara.schlisio@med.uni-tuebingen.de
Contact: Fabian Kreß Fabian.kress@student.uni-tuebingen.de

Locations
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Germany
University Tuebingen, clinic of anästhesiology and intensiv care Recruiting
Tuebingen, Germany, 72074
Contact: Barabar Schlisio, Dr. med    07071/2985612    barbara.schlisio@med.uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
More Information
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03355352    
Other Study ID Numbers: 277/2017BO1
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Tuebingen:
Zalviso
sufentanyl
PCA
Dipidolor
Additional relevant MeSH terms:
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Sufentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics