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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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04026074
Enrollment
50
Registered
2019-07-19
Start date
2019-07-26
Completion date
2019-10-18
Last updated
2019-10-21

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

Conditions

Knee Arthropathy, Hip Arthritis, Fractures, Closed

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.

Interventions

DRUGFentanyl

Weight adapted drug application

DRUGRemifentanil

Weight adapted drug application

DRUGClonidine

Weight adapted drug application

DRUGEMLA Cream

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

DRUGPlacebo iv

i.v. administration of 0,9% NaCl

DRUGPlacebo salve

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

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients planed electively for orthopedic surgery

Exclusion criteria

* Missing patient's consent * Intolerance against study medication

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity during placement of the regional anaesthesia1 dayPain 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

MeasureTime frameDescription
Patients' wellbeing1 dayWellbeing 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)Through study completion, an average of 1 dayComplications on operation day will be recorded and compared between the treatment groups.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026