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Status unknownNCT03355352Updated Nov 28, 2017

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

An observational study in Analgesic Quality and Mobility, sponsored by University Hospital Tuebingen. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-28.

Sponsored by University Hospital Tuebingen · Observational

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Analgesic Quality
  • Mobility

Keywords

  • Zalviso
  • sufentanyl
  • PCA
  • Dipidolor
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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.

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

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
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients treated with conventional i.v. PCA
  • Patients treated with Zalviso

    Drug: Sufentanil

Interventions

  • DrugSufentanil

    Sufentail sublingual 15ug nanopills

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

  2. mobility

    Recording of the patients mobility postoperative while being treated with the conventional PCA or the Zalviso system.

    Time frame: 1 year

Secondary outcomes

  1. medical cost efficiency

    Comparison of the cost efficiency of both systems

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • University Tuebingen, clinic of anästhesiology and intensiv care
    Tuebingen, 72074, Germany
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03355352
Lead sponsor
University Hospital Tuebingen
Responsible party
Sponsor
First posted
Nov 28, 2017
Start date
Nov 1, 2017
Primary completion
Aug 1, 2018 (estimated)
Completion
Dec 1, 2018 (estimated)
Last update
Nov 28, 2017

Study contacts

Barbara Schlisio, Dr. med.
Contact
barbara.schlisio@med.uni-tuebingen.de
07071/2985612

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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