Concepts for Analgosedation During Placement of Regional Anaesthesia Before Operations.

Phase 4

Completed

• Conditions: Hip Arthritis; Knee Arthropathy; Fractures, Closed
• Interventions: Drug: Clonidine; Drug: Placebo iv; Drug: Fentanyl; Drug: EMLA Cream; Drug: Remifentanil; Drug: Placebo salve

• Registration Number: NCT04026074
• Lead Sponsor: Medical University of Graz

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 Timeline

• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-19
• Study Start: 2019-07-26
• Status Verified: 2019-10
• Primary Completion: 2019-10-16
• Study Completion: 2019-10-18
• Last Update Submitted: 2019-10-18
• Last Update Posted: 2019-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Adult patients planed electively for orthopedic surgery

Exclusion Criteria

• Missing patient's consent
• Intolerance against study medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clonidine i.v.	Clonidine	Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
Placebo	Placebo iv	Patients will be administered i.v. placebo (0,9% NaCl) and placebo salve (skin protection salve)
Fentanyl i.v. (intravenously)	Fentanyl	Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
Remifentanil i.v.	Placebo salve	Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
EMLA salve	Placebo iv	Patients will be administered the medication (salve) and additionally will be administered i.v. saline as placebo
Fentanyl i.v. (intravenously)	Placebo salve	Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
Clonidine i.v.	Placebo salve	Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
EMLA salve	EMLA Cream	Patients will be administered the medication (salve) and additionally will be administered i.v. saline as placebo
Placebo	Placebo salve	Patients will be administered i.v. placebo (0,9% NaCl) and placebo salve (skin protection salve)
Remifentanil i.v.	Remifentanil	Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)

Primary Outcome Measures

Name	Time	Method
Pain intensity during placement of the regional anaesthesia	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 Outcome Measures

Name	Time	Method
Complication rate (delirium, allergic reactions, cardiopulmonary decompensation)	Through study completion, an average of 1 day	Complications on operation day will be recorded and compared between the treatment groups.
Patients' wellbeing	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.

Trial Locations

Locations (1)

Medical University Hospital LKH Graz; 🇦🇹 Graz, Austria