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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl i.v. (intravenously) | Experimental | Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve) |
|
| Remifentanil i.v. | Experimental | Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve) |
|
| Clonidine i.v. | Experimental | Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve) |
|
| EMLA salve | Experimental | Patients will be administered the medication (salve) and additionally will be administered i.v. saline as placebo |
|
| Placebo | Placebo Comparator | Patients will be administered i.v. placebo (0,9% NaCl) and placebo salve (skin protection salve) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | Weight adapted drug application |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregor A Schittek, MD | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Hospital LKH Graz | Graz | 8036 | Austria |
After publication of our results, all data will be made available in respect to the austrian data privacy laws
After publication of our results, all data will be made available in respect to the austrian data privacy laws. Expected for Summer 2020.
Research groups interested in the data will be granted access.
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| ID | Term |
|---|---|
| D005596 | Fractures, Closed |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D000077208 | Remifentanil |
| D003000 | Clonidine |
| D000077442 | Lidocaine, Prilocaine Drug Combination |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011422 | Propionates |
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| Remifentanil |
| Drug |
Weight adapted drug application |
|
| Clonidine | Drug | Weight adapted drug application |
|
| EMLA Cream | Drug | Salve application on the body part where the regional anaesthesia will be administered |
|
| Placebo iv | Drug | i.v. administration of 0,9% NaCl |
|
| Placebo salve | Drug | Skin protection salve (placebo salve) application on the body part where the regional anaesthesia will be administered |
|
| Complication rate (delirium, allergic reactions, cardiopulmonary decompensation) | Complications on operation day will be recorded and compared between the treatment groups. | Through study completion, an average of 1 day |
| D000144 |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D008012 | Lidocaine |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D011318 | Prilocaine |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |