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.
Overview
- Phase
- Phase 4
- Intervention
- Placebo salve
- Conditions
- Knee Arthropathy
- Sponsor
- Medical University of Graz
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Pain intensity during placement of the regional anaesthesia
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients planed electively for orthopedic surgery
Exclusion Criteria
- •Missing patient's consent
- •Intolerance against study medication
Arms & Interventions
Fentanyl i.v. (intravenously)
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
Intervention: Placebo salve
Fentanyl i.v. (intravenously)
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
Intervention: Fentanyl
Remifentanil i.v.
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
Intervention: Remifentanil
Remifentanil i.v.
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
Intervention: Placebo salve
Clonidine i.v.
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
Intervention: Clonidine
Clonidine i.v.
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
Intervention: Placebo salve
EMLA salve
Patients will be administered the medication (salve) and additionally will be administered i.v. saline as placebo
Intervention: EMLA Cream
EMLA salve
Patients will be administered the medication (salve) and additionally will be administered i.v. saline as placebo
Intervention: Placebo iv
Placebo
Patients will be administered i.v. placebo (0,9% NaCl) and placebo salve (skin protection salve)
Intervention: Placebo iv
Placebo
Patients will be administered i.v. placebo (0,9% NaCl) and placebo salve (skin protection salve)
Intervention: Placebo salve
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Complication rate (delirium, allergic reactions, cardiopulmonary decompensation)(Through study completion, an average of 1 day)
- Patients' wellbeing(1 day)