Knee ArthropathyPhase 4NCT04026074
Concepts for Analgosedation During Placement of Regional Anaesthesia Before Operations.
A Phase 4 study testing Fentanyl, Remifentanil and Clonidine in people with Knee Arthropathy and Hip Arthritis, run by Medical University of Graz at 1 site in Austria.
Trial summary
Aim of the study is to specify the best analgosedation technique during placement of regional anaesthesia from the patients' view. In this double blind randomized trial the investigators will be testing the application of drugs administered intravenously (fentanyl-bolus, remifentanil-infusion, clonidine-bolus) or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthropathy, Hip Arthritis, Fractures, Closed
- What is being tested?
- Fentanyl, Remifentanil and Clonidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 26 Jul 2019to 18 Oct 2019
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients planed electively for orthopedic surgery
Who cannot join
- Missing patient's consent
- Intolerance against study medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Doubleblind Pilot Study Comparing Analgosedation Concepts During Placement of Regional Anaesthesia With Either Fentanyl, Remifentanil, Clonidine, EMLA-Patch or Placebo in Regard of Pain Reduction.
Aim of the study is to specify the best analgosedation technique during placement of regional anaesthesia from the patients' view.
In this double blind randomized trial the investigators will be testing the application of drugs administered intravenously (fentanyl-bolus, remifentanil-infusion, clonidine-bolus) or transcutaneously (EMLA salve) or placebo (NaCl 0,9% i.v. and skin protection salve).
Read the detailed description
In this doubleblind randomized pilot trial, patients will receive one of five possible combinations to assess which medication leads to the best medication during placement of regional anaesthesia. This assessement includes NRS, patients' satisfaction and wellbeing. The tested substances will be administered intravenously (fentanyl-bolus, remifentanil-infusion, clonidine-bolus) or transcutaneously (EMLA salve). The fifth combination will be the control group with only placebo medication. We expected to get first information for objectifying analgosedation during placement of regional anaesthesia for the conduction of further studies in this field.
- Conditions
- Knee Arthropathy, Hip Arthritis, Fractures, Closed
- Being tested
- Fentanyl, Remifentanil, Clonidine, EMLA Cream, Placebo iv
- Medical subject headings
- Fractures, Closed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Weight adapted drug application
RemifentanilDrug
Weight adapted drug application
ClonidineDrug
Weight adapted drug application
EMLA CreamDrug
Salve application on the body part where the regional anaesthesia will be administered
Placebo ivDrug
i.v. administration of 0,9% NaCl
Placebo salveDrug
Skin protection salve (placebo salve) application on the body part where the regional anaesthesia will be administered
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl i.v. (intravenously) | Experimental | Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve) Receives: Drug: Fentanyl; Drug: Placebo salve |
| Remifentanil i.v. | Experimental | Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve) Receives: Drug: Remifentanil; Drug: Placebo salve |
| Clonidine i.v. | Experimental | Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve) Receives: Drug: Clonidine; Drug: Placebo salve |
| EMLA salve | Experimental | Patients will be administered the medication (salve) and additionally will be administered i.v. saline as placebo Receives: Drug: EMLA Cream; Drug: Placebo iv |
| Placebo | Placebo comparator | Patients will be administered i.v. placebo (0,9% NaCl) and placebo salve (skin protection salve) Receives: Drug: Placebo iv; Drug: Placebo salve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity during placement of the regional anaesthesia
Pain assessment during placement of the regional anaesthesia with the Numeric Rating Scale (NRS 1 to 10, with 1=lowest pain score, 10=highest pain score). Lower NRS describes a better outcome.
Measured: 1 day
Secondary outcomes (2)
Patients' wellbeing
Wellbeing assessment during placement of the regional anaesthesia with the anaesthesiological questionnaire (ANP anaesthesiological Questionnaire is a self-rating method for the assessment of postoperative complaints, patient wellbeing and satisfaction. The rating scales from 0 to 3, with 0="none" and 3="strongly"). Higher wellbeing values represent a better outcome.
Measured: 1 day
Complication rate (delirium, allergic reactions, cardiopulmonary decompensation)
Complications on operation day will be recorded and compared between the treatment groups.
Measured: Through study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start26 Jul 2019
- Primary completion16 Oct 2019
- Study completion18 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregor A Schittek, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026074
- Sponsor's protocol ID
- 2
- Status last verified
- Oct 2019
- First submitted
- 17 Jul 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of our results, all data will be made available in respect to the austrian data privacy laws
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Doubleblind Pilot Study Comparing Analgosedation Concepts During Placement of Regional Anaesthesia With Either Fentanyl, Remifentanil, Clonidine, EMLA-Patch or Placebo in Regard of Pain Reduction.
- ClinicalTrials.gov ID
- NCT04026074
- Acronym / sponsor ID
- 2
- Conditions
- Knee Arthropathy, Hip Arthritis, Fractures, Closed
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 19 Jul 2019 (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.
Aim of the study is to specify the best analgosedation technique during placement of regional anaesthesia from the patients' view.
In this double blind randomized trial the investigators will be testing the application of drugs administered intravenously (fentanyl-bolus, remifentanil-infusion, clonidine-bolus) or transcutaneously (EMLA salve) or placebo (NaCl 0,9% i.v. and skin protection salve).
Detailed description
In this doubleblind randomized pilot trial, patients will receive one of five possible combinations to assess which medication leads to the best medication during placement of regional anaesthesia. This assessement includes NRS, patients' satisfaction and wellbeing. The tested substances will be administered intravenously (fentanyl-bolus, remifentanil-infusion, clonidine-bolus) or transcutaneously (EMLA salve). The fifth combination will be the control group with only placebo medication. We expected to get first information for objectifying analgosedation during placement of regional anaesthesia for the conduction of further studies in this field.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Fentanyl i.v. (intravenously) | Experimental | Drug: Fentanyl, Drug: Placebo salvePatients will be administered the medication and additionally will be treated with placebo salve (skin protection salve) |
| Remifentanil i.v. | Experimental | Drug: Remifentanil, Drug: Placebo salvePatients will be administered the medication and additionally will be treated with placebo salve (skin protection salve) |
| Clonidine i.v. | Experimental | Drug: Clonidine, Drug: Placebo salvePatients will be administered the medication and additionally will be treated with placebo salve (skin protection salve) |
| EMLA salve | Experimental | Drug: EMLA Cream, Drug: Placebo ivPatients will be administered the medication (salve) and additionally will be administered i.v. saline as placebo |
| Placebo | Placebo comparator | Drug: Placebo iv, Drug: Placebo salvePatients will be administered i.v. placebo (0,9% NaCl) and placebo salve (skin protection salve) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients planed electively for orthopedic surgery
Key exclusion criteria (2 listed)
- Missing patient's consent
- Intolerance against study medication
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 |
|---|---|---|
| FentanylWeight adapted drug application | Drug | Fentanyl i.v. (intravenously) |
| RemifentanilWeight adapted drug application | Drug | Remifentanil i.v. |
| ClonidineWeight adapted drug application | Drug | Clonidine i.v. |
| EMLA CreamSalve application on the body part where the regional anaesthesia will be administered | Drug | EMLA salve |
| Placebo ivi.v. administration of 0,9% NaCl | Drug | EMLA salve, Placebo |
| Placebo salveSkin protection salve (placebo salve) application on the body part where the regional anaesthesia will be administered | Drug | Clonidine i.v., Fentanyl i.v. (intravenously), Placebo, Remifentanil i.v. |
Primary outcome
Pain intensity during placement of the regional anaesthesia
Time frame: 1 day
Pain assessment during placement of the regional anaesthesia with the Numeric Rating Scale (NRS 1 to 10, with 1=lowest pain score, 10=highest pain score). Lower NRS describes a better outcome.
2 secondary outcomes
Patients' wellbeing
Time frame: 1 day
Complication rate (delirium, allergic reactions, cardiopulmonary decompensation)
Time frame: Through study completion, an average of 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Individual participant dataSharing planned: Yes. After publication of our results, all data will be made available in respect to the austrian data privacy laws
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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.
Gregor A Schittek, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl, Remifentanil and Clonidine in people with Knee Arthropathy and Hip Arthritis, run by Medical University of Graz at 1 site in Austria.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 21 Oct 2019. 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 Austria. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity during placement of the regional anaesthesia (time frame: 1 day). 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 21 Oct 2019.