MedDataX Logo

Prolongation of Pain Free Time by the Use of Dexamethasone in Peripheral Nerve Blockade

NCT ID: NCT02178449

Last Updated: 2014-06-30

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-05-31

Brief Summary

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

The main aim of the study is to investigate the proven effect of dexamethsone on the duration of the interscalene block. The investigators try to define optimal dose and volume for ropivacaine, when used together with dexamethsone. The current literature uses often very high volumes of ropivacain when used together with dexamethasone. The investigators try to research the effect of using dexamethsone together with low volume, high concentration ropivacaine for interscalene blockade. The investigators' hypothesis is that dexamethasone has an positive effect on the pain free after used together with ropivacaine at the scalene block.

Detailed Description

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

Conditions

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

Interscalene Block Shoulder Arthroscopy Dexamethasone Low Volume Regional Anesthesia

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

TRIPLE

Participants Caregivers Investigators

Study Groups

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

Verum

Dexamethasone and Ropivacaine

Group Type EXPERIMENTAL

Dexamethasone acetate

Intervention Type DRUG

Ropivacaine

Intervention Type DRUG

Placebo

Ropivacaine and Saline

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Ropivacaine

Intervention Type DRUG

Interventions

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

Dexamethasone acetate

Intervention Type DRUG

Placebo

Intervention Type DRUG

Ropivacaine

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* atroscopy of the shoulder
* repair of the RM

Exclusion Criteria

* patient under 18 years
* patient is fertile
* chronic opiat use more than 30mg oxycodone per day
* operations at the shoulder that involves the bone
* usage of cortisone for more than 2 weeks
* risk greater as asa III
* damage to nerves
* neuropathy at the target arm
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.

Landesklinikum Sankt Polten

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.

Christoph Hörmann, MD

Role: STUDY_DIRECTOR

Landesklinikum Sankt Polten

Locations

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

Landesklinikum Sankt Pölten

Sankt Pölten, Lower Austria, Austria

Site Status RECRUITING

Landesklinikum Sankt Pölten

Sankt Pölten, Lower Austria, Austria

Site Status RECRUITING

Countries

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

Austria

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christoph Hörmann, MD

Role: CONTACT

Phone: + 43 2742 9004

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Christoph Hörmann, MD

Role: primary

Christoph Hörmann, MD

Role: primary

Other Identifiers

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

GS4-EK-2/304-2013

Identifier Type: OTHER

Identifier Source: secondary_id

DEXATrial1

Identifier Type: -

Identifier Source: org_study_id