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

November 27, 2017 updated by: University Hospital Tuebingen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72074
        • Recruiting
        • University Tuebingen, clinic of anästhesiology and intensiv care
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
mobility
Time Frame: 1 year
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
Time Frame: 1 year
Comparison of the cost efficiency of both systems
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 20, 2017

First Submitted That Met QC Criteria

November 27, 2017

First Posted (Actual)

November 28, 2017

Study Record Updates

Last Update Posted (Actual)

November 28, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 277/2017BO1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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