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

Dexamethasone Clinical Trial

Official title:

The Effect of Dexamethasone Used Together With Low Volume Ropivacaine in a Single Shot Interscalene Block on the Pain Free Time Experienced by the Patient

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02178449
• Other study ID #: DEXATrial1
• Secondary ID: GS4-EK-2/304-201
• Status: Unknown status
• Phase: Phase 4
• First received: May 26, 2014
• Last updated: June 27, 2014
• Start date: March 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2014
• Source: Landesklinikum Sankt Polten
• Contact: Christoph Hörmann, MD
• Phone: + 43 2742 9004
• Email: office[@]stpoelten.lknoe.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 109
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dexamethasone
• Interscalene Block
• Low Volume Regional Anesthesia
• Shoulder Arthroscopy

Intervention

Drug:
• Dexamethasone acetate

• Placebo

• Ropivacaine

Locations

Country	Name	City	State
Austria	Landesklinikum Sankt Pölten	Sankt Pölten	Lower Austria
Austria	Landesklinikum Sankt Pölten	Sankt Pölten	Lower Austria

Sponsors (1)

Lead Sponsor	Collaborator
Landesklinikum Sankt Polten

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction	Measured by a validated questionary	1 day, when the patient leaves the hospital
Primary	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	Visual Rating Scale for Pain at Movement and Rest		Measured 10 hours after the intervention