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

Mobility Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03355352
• Other study ID #: 277/2017BO1
• Status: Recruiting
• Phase: N/A
• First received: November 20, 2017
• Last updated: November 27, 2017
• Start date: November 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: November 2017
• Source: University Hospital Tuebingen
• Contact: Barbara Schlisio, Dr. med.
• Phone: 07071/2985612
• Email: barbara.schlisio[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesic Quality
• Mobility

Intervention

Drug:
• Sufentanil
Sufentail sublingual 15ug nanopills

Locations

Country	Name	City	State
Germany	University Tuebingen, clinic of anästhesiology and intensiv care	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	mobility	Recording of the patients mobility postoperative while being treated with the conventional PCA or the Zalviso system.	1 year
Secondary	medical cost efficiency	Comparison of the cost efficiency of both systems	1 year