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

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03355352
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 7.7

Study Details

Study Description

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	Phase
Analgesic Quality; Mobility	Drug: Sufentanil

Study Design

• Study Type: Observational
• Anticipated 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: Nov 1, 2017
• Anticipated Primary Completion Date: Aug 1, 2018
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. analgesic quality [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 [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 [1 year]

   Comparison of the cost efficiency of both systems

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University Tuebingen, clinic of anästhesiology and intensiv care	Tuebingen		Germany	72074

Sponsors and Collaborators

• University Hospital Tuebingen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Tuebingen
• ClinicalTrials.gov Identifier: NCT03355352
• Other Study ID Numbers: 277/2017BO1
• First Posted: Nov 28, 2017
• Last Update Posted: Nov 28, 2017
• Last Verified: Nov 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Sufentanil

Study Results

No Results Posted as of Nov 28, 2017