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.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Pain intensity during placement of the regional anaesthesia
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients planed electively for orthopedic surgery
Exclusion Criteria
- •Missing patient's consent
- •Intolerance against study medication
Arms & Interventions
Placebo
Patients will be administered i.v. placebo (0,9% NaCl) and placebo salve (skin protection salve)
Intervention: Placebo iv (Drug)
Remifentanil i.v.
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
Intervention: Placebo salve (Drug)
EMLA salve
Patients will be administered the medication (salve) and additionally will be administered i.v. saline as placebo
Intervention: Placebo iv (Drug)
Fentanyl i.v. (intravenously)
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
Intervention: Placebo salve (Drug)
Clonidine i.v.
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
Intervention: Placebo salve (Drug)
Placebo
Patients will be administered i.v. placebo (0,9% NaCl) and placebo salve (skin protection salve)
Intervention: Placebo salve (Drug)
EMLA salve
Patients will be administered the medication (salve) and additionally will be administered i.v. saline as placebo
Intervention: EMLA Cream (Drug)
Fentanyl i.v. (intravenously)
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
Intervention: Fentanyl (Drug)
Clonidine i.v.
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
Intervention: Clonidine (Drug)
Remifentanil i.v.
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
Intervention: Remifentanil (Drug)
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)