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.

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).

Study Overview

• Status: Completed
• Conditions: Fractures, Closed; Hip Arthritis; Knee Arthropathy
• Intervention / Treatment: Drug: Fentanyl; Drug: Placebo salve; Drug: Remifentanil; Drug: Clonidine; Drug: EMLA Cream; Drug: Placebo iv

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University Hospital LKH Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients planed electively for orthopedic surgery

Exclusion Criteria:

• Missing patient's consent
• Intolerance against study medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fentanyl i.v. (intravenously); Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)	Drug: Fentanyl; Weight adapted drug application; Drug: Placebo salve; Skin protection salve (placebo salve) application on the body part where the regional anaesthesia will be administered
Experimental: Remifentanil i.v.; Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)	Drug: Placebo salve; Skin protection salve (placebo salve) application on the body part where the regional anaesthesia will be administered; Drug: Remifentanil; Weight adapted drug application
Experimental: Clonidine i.v.; Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)	Drug: Placebo salve; Skin protection salve (placebo salve) application on the body part where the regional anaesthesia will be administered; Drug: Clonidine; Weight adapted drug application
Experimental: EMLA salve; Patients will be administered the medication (salve) and additionally will be administered i.v. saline as placebo	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
Placebo Comparator: Placebo; Patients will be administered i.v. placebo (0,9% NaCl) and placebo salve (skin protection salve)	Drug: Placebo salve; Skin protection salve (placebo salve) application on the body part where the regional anaesthesia will be administered; Drug: Placebo iv; i.v. administration of 0,9% NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Gregor A Schittek, MD, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2019
• Primary Completion (Actual): October 16, 2019
• Study Completion (Actual): October 18, 2019

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): October 21, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Closed; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Anesthetics, Combined; Sympatholytics; Remifentanil; Fentanyl; Lidocaine, Prilocaine Drug Combination; Clonidine
• Other Study ID Numbers: 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication of our results, all data will be made available in respect to the austrian data privacy laws
• IPD Sharing Time Frame: After publication of our results, all data will be made available in respect to the austrian data privacy laws. Expected for Summer 2020.
• IPD Sharing Access Criteria: Research groups interested in the data will be granted access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No