Concepts for Analgosedation During Placement of Regional Anaesthesia Before Operations.

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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.

Conditions
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Knee Arthropathy, Hip Arthritis, Fractures, Closed

Intervention / Treatment
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* Drug: Fentanyl
* Drug: Remifentanil
* Drug: Clonidine
* Drug: EMLA Cream
* Drug: Placebo iv
* Drug: Placebo salve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients planed electively for orthopedic surgery Exclusion Criteria: Missing patient's consent Intolerance against study medication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fentanyl i.v. (intravenously)<br>Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve) | Drug: Fentanyl<br>* Weight adapted drug application<br>Drug: Placebo salve<br>* Skin protection salve (placebo salve) application on the body part where the regional anaesthesia will be administered<br>|
| Experimental: Remifentanil i.v.<br>Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve) | Drug: Remifentanil<br>* Weight adapted drug application<br>Drug: Placebo salve<br>* Skin protection salve (placebo salve) application on the body part where the regional anaesthesia will be administered<br>|
| Experimental: Clonidine i.v.<br>Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve) | Drug: Clonidine<br>* Weight adapted drug application<br>Drug: Placebo salve<br>* Skin protection salve (placebo salve) application on the body part where the regional anaesthesia will be administered<br>|
| Experimental: EMLA salve<br>Patients will be administered the medication (salve) and additionally will be administered i.v. saline as placebo | Drug: EMLA Cream<br>* Salve application on the body part where the regional anaesthesia will be administered<br>Drug: Placebo iv<br>* i.v. administration of 0,9% NaCl<br>|
| Placebo Comparator: Placebo<br>Patients will be administered i.v. placebo (0,9% NaCl) and placebo salve (skin protection salve) | Drug: Placebo iv<br>* i.v. administration of 0,9% NaCl<br>Drug: Placebo salve<br>* Skin protection salve (placebo salve) application on the body part where the regional anaesthesia will be administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |