Prolongation of Pain Free Time by the Use of Dexamethason... | NCT02178449

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

NCT02178449

Sponsor

Landesklinikum Sankt Polten

Status

Unknown status

Last Update Posted

Jun 30, 2014Estimated

Enrollment

109Estimated

Phase

Phase 4

Conditions

Interscalene Block
Shoulder Arthroscopy
Dexamethasone
Low Volume Regional Anesthesia

Interventions

Dexamethasone acetate
Placebo
Ropivacaine

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
GS4-EK-2/304-2013	Other Identifier	Ethics commission of lower austria

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Apr 2015Estimated

Completion Date

May 2015Estimated

First Submitted Date

May 26, 2014

First Submission Date that Met QC Criteria

Jun 27, 2014

First Posted Date

Jun 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2014

Last Update Posted Date

Jun 30, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

109Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Verum	Experimental	Dexamethasone and Ropivacaine	Drug: Dexamethasone acetate Drug: Ropivacaine
Placebo	Active Comparator	Ropivacaine and Saline	Drug: Placebo Drug: Ropivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone acetate	Drug		Verum
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain free time measured by the duration between block and the point at which the patient is asking for painkillers		Patients will be followed during their stay at the hospital, which will be normally around 24 to 48 hours.

Secondary Outcomes

Measure	Description	Time Frame
Visual Rating Scale for Pain at Movement and Rest		Measured 10 hours after the intervention

Other Outcomes

Measure	Description	Time Frame
Patient satisfaction	Measured by a validated questionary	1 day, when the patient leaves the hospital

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christoph Hörmann, MD	Contact	+ 43 2742 9004		office@stpoelten.lknoe.at

Overall Officials

Name	Affiliation	Role
Christoph Hörmann, MD	Landesklinikum Sankt Polten	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Landesklinikum Sankt Pölten	Recruiting	Sankt Pölten	Lower Austria	3100	Austria

Type	Date	Date Unknown
Release	Oct 1, 2015
Reset	Oct 29, 2015
Release	Mar 2, 2016
Reset	Mar 31, 2016
Release	Apr 1, 2016
Reset	May 6, 2016

Submission Tracking

Estimated Results First Submitted Date

Oct 1, 2015

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 1, 2015			Oct 29, 2015
Mar 2, 2016

Intervention Browse Module

MeSH Terms

ID	Term
C018038	dexamethasone acetate
D000077212	Ropivacaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided