NCT04026074

Concepts for Analgosedation During Placement of Regional Anaesthesia Before Operations.

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Arthropathy
• Hip Arthritis
• Fractures, Closed

Interventions

Type	Name	Description
DRUG	Fentanyl	Weight adapted drug application
DRUG	Remifentanil	Weight adapted drug application
DRUG	Clonidine	Weight adapted drug application
DRUG	EMLA Cream	Salve application on the body part where the regional anaesthesia will be administered
DRUG	Placebo iv	i.v. administration of 0,9% NaCl
DRUG	Placebo salve	Skin protection salve (placebo salve) application on the body part where the regional anaesthesia will be administered

Timeline

• Start date: 2019-07-26
• Primary completion: 2019-10-16
• Completion: 2019-10-18
• First posted: 2019-07-19
• Last updated: 2019-10-21

Locations

1 site across 1 country: Austria