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

July 13, 2014 updated by: Hillel Yaffe Medical Center

Comparison Between Perineural and Systemic Effect of Dexamethasone as an Adjuvant for Prolongation of the Interscalene Brachial Plexus Block.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I (ISB-P)
Interscalene block with perineural injection of dexamethasone 0.1 mg/kg
Drug: Dexamethasone
Drug: Bupivacaine
Active Comparator: Group II (ISB-S)
Interscalene block with systemically injection of dexamethasone 0.1 mg/kg.
Drug: Dexamethasone
Drug: Bupivacaine
Active Comparator: Group III - ISB-C
Interscalene block without adjuvant.
Drug: Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy DxaM Perineural
Time Frame: One day
Duration of motor and sensory block.
One day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Systemic DxaM
Time Frame: One day
Duration of motor and sensory block
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Anatoly Stav, MD, Hillel Yaffe Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

July 13, 2014

First Submitted That Met QC Criteria

July 13, 2014

First Posted (Estimate)

July 15, 2014

Study Record Updates

Last Update Posted (Estimate)

July 15, 2014

Last Update Submitted That Met QC Criteria

July 13, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYMC-13.7.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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