Concepts for Analgosedation During Placement of Regional Anaesthesia Before Operations.

Knee Arthropathy Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04026074
• Other study ID #: 2
• Status: Completed
• Phase: Phase 4
• Start date: July 26, 2019
• Est. completion date: October 18, 2019

Study information

• Verified date: October 2019
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 18, 2019
• Est. primary completion date: October 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients planed electively for orthopedic surgery

Exclusion Criteria:

• Missing patient's consent

• Intolerance against study medication

Related Conditions & MeSH terms

• Fractures, Closed
• Hip Arthritis
• Joint Diseases
• Knee Arthropathy

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University Hospital LKH Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity during placement of the regional anaesthesia	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.	1 day
Secondary	Patients' wellbeing	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.	1 day
Secondary	Complication rate (delirium, allergic reactions, cardiopulmonary decompensation)	Complications on operation day will be recorded and compared between the treatment groups.	Through study completion, an average of 1 day