Analgesic QualityNCT03355352
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 of Analgesic Quality and Mobility, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesic Quality, Mobility
- What is being tested?
- Sufentanil
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2017to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients at the teaching hospital of university tuebingen which get an surgical urological intervention and which correspond with the inclusion criteria.
Who may be able to join
- Patients after urological interventions with no indication of an periduralanästesia
- Patients compliant for a PCA system, and complied with the analysis of their data
Who cannot join
- 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
Show all 10Show fewer
- F15.2 dependence syndrome coffin
- F.16.2 dependence syndrome hallucinogens
- F22 schizophrenia
- F41.1 generalized anxiety disorder
Trial locations and contacts
1 site in 1 country.
Fabian Kreß contact
Germany1 site, 1 recruiting
- Recruiting
University Tuebingen, clinic of anästhesiology and intensiv care
Tübingen, 72074
Barabar Schlisio, Dr. med, 07071/2985612, barbara.schlisio@med.uni-tuebingen.de
About this study
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
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
- Being tested
- Sufentanil
- Keywords
- Zalviso, sufentanyl, PCA, Dipidolor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SufentanilDrug
Sufentail sublingual 15ug nanopills
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with conventional i.v. PCA | Not described | |
| Patients treated with Zalviso | Not described Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
mobility
Recording of the patients mobility postoperative while being treated with the conventional PCA or the Zalviso system.
Measured: 1 year
Secondary outcomes (1)
medical cost efficiency
Comparison of the cost efficiency of both systems
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start1 Nov 2017
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesic QualityStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355352
- Sponsor's protocol ID
- 277/2017BO1
- Status last verified
- Nov 2017
- First submitted
- 20 Nov 2017
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03355352
- Acronym / sponsor ID
- 277/2017BO1
- Conditions
- Analgesic Quality, Mobility
- Keywords
- Zalviso, sufentanyl, PCA, Dipidolor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with conventional i.v. PCA | – | – |
| Patients treated with Zalviso | – | Drug: Sufentanil |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients at the teaching hospital of university tuebingen which get an surgical urological intervention and which correspond with the inclusion criteria.
Key inclusion criteria (2 listed)
- Patients after urological interventions with no indication of an periduralanästesia
- Patients compliant for a PCA system, and complied with the analysis of their data
Key exclusion criteria (10 listed)
- F03 dementia
- F10.2 dependence syndrome alcohol
- F11.2 dependence syndrome opioids
- F12.2 dependence syndrome cannabinoids
- F13.2 dependence syndrome sedatives and hypnotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SufentanilSufentail sublingual 15ug nanopills | Drug | Patients treated with Zalviso |
Primary outcome
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.
mobility
Time frame: 1 year
Recording of the patients mobility postoperative while being treated with the conventional PCA or the Zalviso system.
1 secondary outcome
medical cost efficiency
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabian Kreß contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesic Quality and Mobility, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Schlisio, Dr. med. (07071/2985612, barbara.schlisio@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analgesic quality (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.