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Comparison Between Perineural and Systemic Effect of Dexamethasone as an Adjuvant for Prolongation of Four Nerve Blocks With Bupivacaine in Total Knee Arthroplasty

NCT ID: NCT02253784

Last Updated: 2017-10-31

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

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-10-30

Brief Summary

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

Detailed Description

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Conditions

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Analgesia Pain, Postoperative

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)

Four nerve blocks with perineural injection of dexamethasone 0.1 mg/kg and bupivacaine 0.5% - 45 ml

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Bupivacaine

Intervention Type DRUG

Group II (ISB-S)

Four nerve blocks with systemic injection of dexamethasone 0.1 mg/kg and bupivacaine 0.5% - 45 ml

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Bupivacaine

Intervention Type DRUG

Group III (ISB-C)

Four nerve blocks without dexamethasone

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 total knee arthroplasty patients

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

Other Identifiers

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14-XX-HYMC

Identifier Type: -

Identifier Source: org_study_id