Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block.

NCT ID: NCT02190760

Last Updated: 2014-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group I (ISB-P)

Interscalene block with perineural injection of dexamethasone 0.1 mg/kg

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Bupivacaine

Intervention Type DRUG

Group II (ISB-S)

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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Bupivacaine

Intervention Type DRUG

Group III - ISB-C

Interscalene block without adjuvant.

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Interventions

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Dexamethasone

Intervention Type DRUG

Bupivacaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pre-surgical patients for arthroscopic or open shoulder surgery

Exclusion Criteria

* Skin infection near block site
* Allergy to local anesthetics
* Peripheral neuropathy
* Proven opioid dependency
* Coagulopathy
* Dementia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anatoly Stav, MD

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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Anatoly Stav, MD

Role: CONTACT

972-4-6304687

References

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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.

Reference Type DERIVED
PMID: 34554686 (View on PubMed)

Other Identifiers

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HYMC-13.7.14

Identifier Type: -

Identifier Source: org_study_id

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