NCT02190760

Brief Summary

The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the duration of a block. The aim of this study is to determine whether this a systemic or local effect.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

2 years

First QC Date

July 13, 2014

Last Update Submit

July 13, 2014

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

  • Efficacy DxaM Perineural

    Duration of motor and sensory block.

    One day

Secondary Outcomes (1)

  • Efficacy of Systemic DxaM

    One day

Study Arms (3)

Group I (ISB-P)

ACTIVE COMPARATOR

Interscalene block with perineural injection of dexamethasone 0.1 mg/kg

Drug: DexamethasoneDrug: Bupivacaine

Group II (ISB-S)

ACTIVE COMPARATOR

Interscalene block with systemically injection of dexamethasone 0.1 mg/kg.

Drug: DexamethasoneDrug: Bupivacaine

Group III - ISB-C

ACTIVE COMPARATOR

Interscalene block without adjuvant.

Drug: Bupivacaine

Interventions

DexamethasoneDRUG
Group I (ISB-P)Group II (ISB-S)
BupivacaineDRUG
Group I (ISB-P)Group II (ISB-S)Group III - ISB-C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pre-surgical patients for arthroscopic or open shoulder surgery

You may not qualify if:

  • Skin infection near block site
  • Allergy to local anesthetics
  • Peripheral neuropathy
  • Proven opioid dependency
  • Coagulopathy
  • Dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Related Publications (1)

  • Bei T, Liu J, Huang Q, Wu J, Zhao J. Perineural Versus Intravenous Dexamethasone for Brachial Plexus Block: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Pain Physician. 2021 Sep;24(6):E693-E707.

    PMID: 34554686DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

DexamethasoneBupivacaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Anatoly Stav, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anatoly Stav, MD

CONTACT

972-4-6304687stav@hy.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2014

First Posted

July 15, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

July 15, 2014

Record last verified: 2014-07

Locations

IL(1)