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

NCT03355352 | Unknown

• 1 other identifier: 277/2017BO1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesic Quality; Mobility

Keywords

Zalviso; sufentanyl; PCA; Dipidolor

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• mobility

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

  1 year

Secondary Outcomes (1)

• medical cost efficiency

  1 year

Study Arms (2)

Patients treated with conventional i.v. PCA

Patients treated with Zalviso

Drug: Sufentanil

Interventions

Sufentanil DRUG

Sufentail sublingual 15ug nanopills

Patients treated with Zalviso

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients after urological interventions with no indication of an periduralanästesia
• Patients compliant for a PCA system, and complied with the analysis of their data

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Tuebingen, clinic of anästhesiology and intensiv care

Tübingen, 72074, Germany

RECRUITING

MeSH Terms

Interventions

Sufentanil

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Barbara Schlisio, Dr. med.

CONTACT

07071/2985612; barbara.schlisio@med.uni-tuebingen.de

Fabian Kreß

CONTACT

Fabian.kress@student.uni-tuebingen.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 28, 2017
• Study Start: November 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 28, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)