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Concepts for Analgosedation During Placement of Regional Anaesthesia Before Operations.

Primary Purpose

Knee Arthropathy, Hip Arthritis, Fractures, Closed

Status

Completed

Phase

Phase 4

Locations

Austria

Study Type

Interventional

Intervention

Fentanyl

Remifentanil

Clonidine

EMLA Cream

Placebo iv

Placebo salve

About this trial

This is an interventional treatment trial for Knee Arthropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult patients planed electively for orthopedic surgery

Exclusion Criteria:

Missing patient's consent
Intolerance against study medication

Sites / Locations

Medical University Hospital LKH Graz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Fentanyl i.v. (intravenously)

Remifentanil i.v.

Clonidine i.v.

EMLA salve

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Complication rate (delirium, allergic reactions, cardiopulmonary decompensation)

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

Full Information

NCT ID

NCT04026074

First Posted

July 17, 2019

Last Updated

October 18, 2019

Sponsor

Medical University of Graz

1. Study Identification

Unique Protocol Identification Number

NCT04026074

Brief Title

Concepts for Analgosedation During Placement of Regional Anaesthesia Before Operations.

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.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

July 26, 2019 (Actual)

Primary Completion Date

October 16, 2019 (Actual)

Study Completion Date

October 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Arthropathy, Hip Arthritis, Fractures, Closed

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fentanyl i.v. (intravenously)

Arm Type

Experimental

Arm Description

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

Arm Title

Remifentanil i.v.

Arm Type

Experimental

Arm Description

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

Arm Title

Clonidine i.v.

Arm Type

Experimental

Arm Description

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

Arm Title

EMLA salve

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Fentanyl

Intervention Description

Weight adapted drug application

Intervention Type

Drug

Intervention Name(s)

Remifentanil

Intervention Description

Weight adapted drug application

Intervention Type

Drug

Intervention Name(s)

Clonidine

Intervention Description

Weight adapted drug application

Intervention Type

Drug

Intervention Name(s)

EMLA Cream

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo iv

Intervention Description

i.v. administration of 0,9% NaCl

Intervention Type

Drug

Intervention Name(s)

Placebo salve

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain intensity during placement of the regional anaesthesia

Description

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.

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Patients' wellbeing

Description

Time Frame

1 day

Title

Complication rate (delirium, allergic reactions, cardiopulmonary decompensation)

Description

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

Time Frame

Through study completion, an average of 1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients planed electively for orthopedic surgery Exclusion Criteria: Missing patient's consent Intolerance against study medication

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gregor A Schittek, MD

Organizational Affiliation

Medical University of Graz

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University Hospital LKH Graz

City

Graz

ZIP/Postal Code

8036

Country

Austria

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Concepts for Analgosedation During Placement of Regional Anaesthesia Before Operations.

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