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

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

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.

Study Overview

• Status: Unknown
• Conditions: Dexamethasone; Interscalene Block; Shoulder Arthroscopy; Low Volume Regional Anesthesia
• Intervention / Treatment: Drug: Placebo; Drug: Ropivacaine; Drug: Dexamethasone acetate

• Study Type: Interventional
• Enrollment (Anticipated): 109
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Christoph Hörmann, MD; Phone Number: + 43 2742 9004; Email: office@stpoelten.lknoe.at

Study Locations

• Austria
  • Lower Austria
    • Sankt Pölten, Lower Austria, Austria, 3100
      • Recruiting
      • Landesklinikum Sankt Pölten
      • Contact: Christoph Hörmann, MD; Phone Number: +43 2742 9004; Email: office@stpoelten.lknoe.at
      • Principal Investigator: Christoph Hörmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Verum; Dexamethasone and Ropivacaine	Drug: Ropivacaine; Drug: Dexamethasone acetate
Active Comparator: Placebo; Ropivacaine and Saline	Drug: Placebo; Drug: Ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Landesklinikum Sankt Polten
• Investigators: Study Director: Christoph Hörmann, MD, Landesklinikum Sankt Pölten

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): May 1, 2015

Study Registration Dates

• First Submitted: May 26, 2014
• First Submitted That Met QC Criteria: June 27, 2014
• First Posted (Estimate): June 30, 2014

Study Record Updates

• Last Update Posted (Estimate): June 30, 2014
• Last Update Submitted That Met QC Criteria: June 27, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Anesthetics, Local; Dexamethasone; Dexamethasone acetate; BB 1101; Ropivacaine
• Other Study ID Numbers: DEXATrial1; GS4-EK-2/304-2013 (Other Identifier: Ethics commission of lower austria)