Skip to main content
OpenTrials
Completed

NCT Number: NCT04026074

Concepts for Analgosedation During Placement of Regional Anaesthesia Before Operations.

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Arthropathy Fractures, Bone Fractures, Closed Hip Arthritis Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University Hospital LKH Graz

Graz, 8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients planed electively for orthopedic surgery

Exclusion criteria

  • Missing patient's consent
  • Intolerance against study medication

Treatment and study plan

Fentanyl

Drug

Weight adapted drug application

Remifentanil

Drug

Weight adapted drug application

Clonidine

Drug

Weight adapted drug application

EMLA cream

Drug

Salve application on the body part where the regional anaesthesia will be administered

Placebo IV

Drug

i.v. administration of 0,9% NaCl

Placebo salve

Drug

Skin protection salve (placebo salve) application on the body part where the regional anaesthesia will be administered

Primary outcomes

  1. 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

  1. Patients' wellbeing

    Time frame: 1 day

    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.

  2. Complication rate (delirium, allergic reactions, cardiopulmonary decompensation)

    Time frame: Through study completion, an average of 1 day

    Complications on operation day will be recorded and compared between the treatment groups.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 19, 2019
Registry last updated
Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.