Concepts for Analgosedation During Placement of Regional Anaesthesia Before Operations.

NCT04026074 | Completed Phase 4 DMC

• 1 other identifier: 2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Arthropathy; Hip Arthritis; Fractures, Closed

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patients' wellbeing

  1 day

• Complication rate (delirium, allergic reactions, cardiopulmonary decompensation)

  Through study completion, an average of 1 day

Study Arms (5)

Fentanyl i.v. (intravenously)

EXPERIMENTAL

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

Drug: Fentanyl; Drug: Placebo salve

Remifentanil i.v.

EXPERIMENTAL

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

Drug: Remifentanil; Drug: Placebo salve

Clonidine i.v.

EXPERIMENTAL

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

Drug: Clonidine; Drug: Placebo salve

EMLA salve

EXPERIMENTAL

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

Drug: EMLA Cream; Drug: Placebo iv

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo iv; Drug: Placebo salve

Interventions

Fentanyl DRUG

Weight adapted drug application

Fentanyl i.v. (intravenously)

Remifentanil DRUG

Weight adapted drug application

Remifentanil i.v.

Clonidine DRUG

Weight adapted drug application

Clonidine i.v.

EMLA Cream DRUG

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

EMLA salve

Placebo iv DRUG

i.v. administration of 0,9% NaCl

EMLA salve; Placebo

Placebo salve DRUG

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

Clonidine i.v.; Fentanyl i.v. (intravenously); Placebo; Remifentanil i.v.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients planed electively for orthopedic surgery

You may not qualify if:

• Missing patient's consent
• Intolerance against study medication

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Hospital LKH Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Fractures, Closed

Interventions

Fentanyl; Remifentanil; Clonidine; Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Imidazolines; Imidazoles; Azoles; Lidocaine; Acetanilides; Anilides; Amides; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Gregor A Schittek, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: July 26, 2019
• Primary Completion: October 16, 2019
• Study Completion: October 18, 2019
• Last Updated: October 21, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: Research groups interested in the data will be granted access.

Locations

AU (1)