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

Phase 4

• Conditions: Interscalene Block; Shoulder Arthroscopy; Dexamethasone; Low Volume Regional Anesthesia
• Interventions: Drug: Dexamethasone acetate; Drug: Placebo; Drug: Ropivacaine

• Registration Number: NCT02178449
• Lead Sponsor: Landesklinikum Sankt Polten

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 available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-26
• Status Verified: 2014-06
• Study First Submitted QC: 2014-06-27
• Last Update Submitted: 2014-06-27
• Study First Posted: 2014-06-30
• Last Update Posted: 2014-06-30
• Primary Completion: 2015-04
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum	Dexamethasone acetate	Dexamethasone and Ropivacaine
Verum	Ropivacaine	Dexamethasone and Ropivacaine
Placebo	Placebo	Ropivacaine and Saline
Placebo	Ropivacaine	Ropivacaine and Saline

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Visual Rating Scale for Pain at Movement and Rest	Measured 10 hours after the intervention

Trial Locations

Locations (1)

Landesklinikum Sankt Pölten; 🇦🇹 Sankt Pölten, Lower Austria, Austria