Study comparing sedation concepts during placement of regional anaesthesia before operations.

Pilot-Study comparing analgosedation concepts during placement of regional anaesthesia with either fentanyl, remifentanil, clonidine, EMLA-Patch or placebo in regard of patient's wellbeing, pain and satisfaction. A randomised, doubleblind, controlled pilot-study. - Concepts for analgosedation during placement of regional anaesthesia before operations.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000700-14-AT

Enrollment

Registered

2019-06-18

Start date

2019-07-08

Completion date

Unknown

Last updated

2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient with elective orthopedic surgery that will be administered a regional anaesthesia will be subject of the investigation

Interventions

Trade Name: Fentanyl Product Name: Fentanyl Pharmaceutical Form: Concentrate and solvent for solution for injection Other descriptive name: FENTANYL CITRATE Concentration unit: mg/ml milligram(s)/mill

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients planed electively for orthopedic surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Missing patient's consent, intolerance against study medication

Design outcomes

Primary

Measure	Time frame
Main Objective: To specify the best analgosedation technic during placement of regional anaesthesia from the patients view (primary endpoint is pain intensity during placement of the regional anaesthesia).;Secondary Objective: To specify the best analgosedation technic during placement of regional anaesthesia from score analysis durig the procedure defined by perioperative patients' wellbeing and side-effect evauation (delirium, allergic reactions, cardiopulmonary decompensation);Primary end point(s): Patient`s wellbeing, satisfaction and pain during placement of regional anaesthesia;Timepoint(s) of evaluation of this end point: During and after the placement of the needle for the regional anaesthesia	—

Measure

Time frame

Main Objective: To specify the best analgosedation technic during placement of regional anaesthesia from the patients view (primary endpoint is pain intensity during placement of the regional anaesthesia).;Secondary Objective: To specify the best analgosedation technic during placement of regional anaesthesia from score analysis durig the procedure defined by perioperative patients' wellbeing and side-effect evauation (delirium, allergic reactions, cardiopulmonary decompensation);Primary end point(s): Patient`s wellbeing, satisfaction and pain during placement of regional anaesthesia;Timepoint(s) of evaluation of this end point: During and after the placement of the needle for the regional anaesthesia

—

Secondary

Measure	Time frame
Secondary end point(s): Evaluation of the questionnaires for objectivation of patients answer regarding pain and perception;Timepoint(s) of evaluation of this end point: During and after the placement of the needle for the regional anaesthesia	—

Countries

Austria

Contacts

Public ContactDivision of general anaesthesia

Medical University of Graz

gregor.schittek@medunigraz.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026