A Phase 4 interventional study of Fentanyl and Remifentanil in Knee Arthropathy, Hip Arthritis and Fractures, Closed, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-21.
Sponsored by Medical University of Graz · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
Drug: Fentanyl · Drug: Placebo salve
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
Drug: Remifentanil · Drug: Placebo salve
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
Drug: Clonidine · Drug: Placebo salve
Patients will be administered the medication (salve) and additionally will be administered i.v. saline as placebo
Drug: EMLA Cream · Drug: Placebo iv
Patients will be administered i.v. placebo (0,9% NaCl) and placebo salve (skin protection salve)
Drug: Placebo iv · Drug: Placebo salve
Weight adapted drug application
Weight adapted drug application
Weight adapted drug application
Salve application on the body part where the regional anaesthesia will be administered
i.v. administration of 0,9% NaCl
Skin protection salve (placebo salve) application on the body part where the regional anaesthesia will be administered
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.
Time frame: 1 day
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.
Time frame: 1 day
Complication rate (delirium, allergic reactions, cardiopulmonary decompensation)
Complications on operation day will be recorded and compared between the treatment groups.
Time frame: Through study completion, an average of 1 day
Plan to share: Yes — After publication of our results, all data will be made available in respect to the austrian data privacy laws
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Medical University of Graz