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

L

Landesklinikum Sankt Polten

Status and phase

Unknown
Phase 4

Conditions

Shoulder Arthroscopy
Interscalene Block
Low Volume Regional Anesthesia
Dexamethasone

Treatments

Drug: Ropivacaine
Drug: Placebo
Drug: Dexamethasone acetate

Study type

Interventional

Funder types

Other

Identifiers

NCT02178449
GS4-EK-2/304-2013 (Other Identifier)
DEXATrial1

Details and patient eligibility

About

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.

Enrollment

109 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

109 participants in 2 patient groups

Verum
Experimental group
Description:
Dexamethasone and Ropivacaine
Treatment:
Drug: Ropivacaine
Drug: Dexamethasone acetate
Placebo
Active Comparator group
Description:
Ropivacaine and Saline
Treatment:
Drug: Ropivacaine
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Christoph Hörmann, MD

Data sourced from clinicaltrials.gov

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