Concepts for Analgosedation During Placement of Regional Anaesthesia Before Operations.

Medical University of Graz

Status and phase: Completed; Phase 4

Conditions: Hip Arthritis; Fractures, Closed; Knee Arthropathy

Treatments: Drug: Placebo iv; Drug: Placebo salve; Drug: Clonidine; Drug: EMLA Cream; Drug: Fentanyl; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT04026074

2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients planed electively for orthopedic surgery

Exclusion criteria

• Missing patient's consent
• Intolerance against study medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 5 patient groups, including a placebo group

Fentanyl i.v. (intravenously)

Experimental group

Description:

Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)

Treatment:

Drug: Placebo salve

Drug: Fentanyl

Remifentanil i.v.

Experimental group

Description:

Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)

Treatment:

Drug: Remifentanil

Drug: Placebo salve

Clonidine i.v.

Experimental group

Description:

Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)

Treatment:

Drug: Clonidine

Drug: Placebo salve

EMLA salve

Experimental group

Description:

Patients will be administered the medication (salve) and additionally will be administered i.v. saline as placebo

Treatment:

Drug: Placebo iv

Drug: EMLA Cream

Placebo

Placebo Comparator group

Description:

Patients will be administered i.v. placebo (0,9% NaCl) and placebo salve (skin protection salve)

Treatment:

Drug: Placebo iv

Drug: Placebo salve