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
2 other identifiers
interventional
109
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 26, 2014
CompletedFirst Posted
Study publicly available on registry
June 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJune 30, 2014
June 1, 2014
1.1 years
May 26, 2014
June 27, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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 (1)
Visual Rating Scale for Pain at Movement and Rest
Measured 10 hours after the intervention
Other Outcomes (1)
Patient satisfaction
1 day, when the patient leaves the hospital
Study Arms (2)
Verum
EXPERIMENTALDexamethasone and Ropivacaine
Placebo
ACTIVE COMPARATORRopivacaine and Saline
Interventions
Eligibility Criteria
You may qualify if:
- atroscopy of the shoulder
- repair of the RM
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Landesklinikum Sankt Pölten
Sankt Pölten, Lower Austria, 3100, Austria
Landesklinikum Sankt Pölten
Sankt Pölten, Lower Austria, 3100, Austria
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christoph Hörmann, MD
Landesklinikum Sankt Polten
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2014
First Posted
June 30, 2014
Study Start
March 1, 2014
Primary Completion
April 1, 2015
Study Completion
May 1, 2015
Last Updated
June 30, 2014
Record last verified: 2014-06