MedDataX Logo

Concepts for Analgosedation During Placement of Regional Anaesthesia Before Operations.

NCT ID: NCT04026074

Last Updated: 2019-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-26

Study Completion Date

2019-10-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Protracted Effect of Combined Nerve Blocks After Total Knee Arthroplasty

NCT02067078

Total Knee Arthroplasty Pain Nerve Blocks
COMPLETED PHASE4

Comparison Between Blocks or Not in Joint Arthroplasty

NCT06230081

Osteoarthritis of the Knee or Hip
ACTIVE_NOT_RECRUITING NA

Perioperative Analgesia After Knee Arthroplasty

NCT01225484

Knee Arthroplasty
UNKNOWN PHASE4

The Analgesic Effect of Combined Nerve Block and Systemic High Dose Glucocorticoid After Total Knee Arthroplasty.

NCT02374008

Peripheral Nerve Block Pain
COMPLETED PHASE4

Effectiveness of Ultrasound Guided Adductor Canal Block on Chronic Pain in Knee Osteoarthritis

NCT02695654

Knee Osteoarthritis
COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Arthropathy Hip Arthritis Fractures, Closed

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fentanyl i.v. (intravenously)

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

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

Weight adapted drug application

Placebo salve

Intervention Type DRUG

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

Remifentanil i.v.

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

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

Weight adapted drug application

Placebo salve

Intervention Type DRUG

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

Clonidine i.v.

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

Group Type EXPERIMENTAL

Clonidine

Intervention Type DRUG

Weight adapted drug application

Placebo salve

Intervention Type DRUG

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

EMLA salve

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

Group Type EXPERIMENTAL

EMLA Cream

Intervention Type DRUG

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

Placebo iv

Intervention Type DRUG

i.v. administration of 0,9% NaCl

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo iv

Intervention Type DRUG

i.v. administration of 0,9% NaCl

Placebo salve

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fentanyl

Weight adapted drug application

Intervention Type DRUG

Remifentanil

Weight adapted drug application

Intervention Type DRUG

Clonidine

Weight adapted drug application

Intervention Type DRUG

EMLA Cream

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

Intervention Type DRUG

Placebo iv

i.v. administration of 0,9% NaCl

Intervention Type DRUG

Placebo salve

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients planed electively for orthopedic surgery

Exclusion Criteria

* Missing patient's consent
* Intolerance against study medication
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gregor A Schittek, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University Hospital LKH Graz

Graz, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Femoral Triangle Block: Early Mobilization and Postoperative Analgesia After Total Knee Arthroplasty
NCT03518450 COMPLETED NA
Effect of Nervus Cutaneous Femoris Lateralis-Blockade on Moderate Pain Responders After Total Hip Arthroplasty
NCT02344264 COMPLETED PHASE4
Study to Find Optimal Dose of Local Spinal Anesthetic (Mepivacaine) Combined With Narcotic (Fentanyl) For Knee Surgery
NCT01701102 COMPLETED NA
Effectiveness of Analgesia in Total Knee Arthroplasty
NCT01304212 COMPLETED PHASE4
Popliteal Plexus Block for Total Knee Arthroplasty
NCT03439787 TERMINATED PHASE4
Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator Nerve Blockade
NCT03064165 COMPLETED PHASE4
Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery
NCT02289937 COMPLETED PHASE4
Efficacy, Safety, and Pharmacokinetics of Femoral Nerve Block With EXPAREL in Total Knee Arthroplasty
NCT02713178 COMPLETED PHASE3
To Compare lidocaine2%/Clonidine in Combination, With Bupivacaine 0.5 % Alone in Equal Volumes for Combined Sciatic-saphenous Nerve Block in Terms of Selectivity of Blockade
NCT01759524 COMPLETED PHASE4
4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans
NCT02891798 COMPLETED PHASE3
The Effect of Popliteal Plexus Block on Pain After Total Knee Arthroplasty
NCT03198403 COMPLETED PHASE4
Evaluation of Anterior Quadratus Lumborum Block for Postoperative Analgesia in Hip Arthroscopy
NCT03432650 COMPLETED PHASE3
Comparison of Regional Anesthesia Techniques After Total Knee Arthroplasty
NCT03143738 COMPLETED NA
Pericapsular Nerve Group Block for Positional Pain and Postoperative Analgesia in Hip Fractures
NCT05079087 UNKNOWN NA
Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty
NCT01333943 COMPLETED NA
Optimized Perioperative Analgesia Reduces the Prevalence and the Intensity of Phantom Pain in Lower Limb Amputation
NCT00443404 COMPLETED PHASE2/PHASE3
Comparison of Different Analgesic Nerve Blocks in Total Knee Replacement Surgery
NCT06422585 RECRUITING
Ultrasound-guided Selective Blockade of the Saphenous and Obturator Nerves Following Total Knee Arthroplasty
NCT02465827 COMPLETED PHASE4
Does Adding an Additional Numbing Medication Injection in the Thigh Help With Pain Control After Knee Replacement Surgery?
NCT03326999 COMPLETED PHASE4
Comparison of Continuous Femoral Nerve Block and Adductor Canal Block After Total Knee Replacement Therapy
NCT02125903 COMPLETED NA
Addition of Popliteal Plexus Block to Continuous Femoral Nerve Block for Total Knee Arthroplasty
NCT04048889 UNKNOWN NA
Regional Anesthesia for Knee Prothesis Surgery
NCT02451605 UNKNOWN NA
The Analgesic Efficacy of the Ultrasound-Guided Femoral Articular Branch Block for Ambulatory Hip Arthroscopy
NCT03449680 COMPLETED NA
Genicular Nerve Block for Total Knee Arthroplasty
NCT03706313 COMPLETED PHASE4
Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade
NCT01335542 COMPLETED PHASE4