Effect of Dexamethasone and Epinephrine on the Duration of Sciatic Nerve Blocks With Ropivacaine

NCT ID: NCT02104778

Last Updated: 2015-07-16

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

2014-04-30

Study Completion Date

2016-07-31

Brief Summary

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The aim of the present study is to test that adding dexamethasone or epinephrine significantly prolongs the duration of sciatic nerve blocks with ropivacaine and that the magnitude of the effect differs among dexamethasone and epinehrine.

Detailed Description

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In a double-blinded trial utilizing single-injection sciatic nerve block, patients are randomly assigned to one of three groups: control: 0.5% ropivacaine adding normal saline; epinephrine: 0.5% ropivacaine adding epinephrine; dexamethasone: 0.5% ropivacaine adding dexamethasone. We assess time to first analgesic request after post-anaesthesia care unit discharge.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dexamethasone

Dexamethasone 8 mg is added to 0.5% ropivacaine 20 ml for sciatic nerve block.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

In dexamethasone group, dexamethasone 8 mg is added to 0.5% ropivacaine 20 ml for sciatic nerve block.

Control

Normal saline 1 ml is added to 0.5% ropivacaine 20 ml for sciatic nerve block.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

epinephrine

Epinephrine 1:200,000 is added to 0.5% ropivacaine 20 ml for sciatic nerve block.

Group Type EXPERIMENTAL

Epinephrine

Intervention Type DRUG

Epinephrine 1:200,000 is added to 0.5% ropivacaine 20 ml for sciatic nerve block

Interventions

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Dexamethasone

In dexamethasone group, dexamethasone 8 mg is added to 0.5% ropivacaine 20 ml for sciatic nerve block.

Intervention Type DRUG

Epinephrine

Epinephrine 1:200,000 is added to 0.5% ropivacaine 20 ml for sciatic nerve block

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists physical status I and II
* patients undergoing elective hallux valgus repair

Exclusion Criteria

* patients receiving chronic analgesic therapy
* diabetes
* peripheral neuropathies
* psychiatric disorders
* hypersensitivity to amide local anesthetics
* renal disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yeungnam University College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Sangjin Park

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sangjin Park, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea

Locations

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Department of Anesthesiology and Pain Medicine, Yeungnam University hospital

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sangjin Park, M.D.

Role: CONTACT

82-53-620-3366

Facility Contacts

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Duckhee Lee, M.D.

Role: primary

82-53-620-3365

Other Identifiers

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apsj20140401

Identifier Type: -

Identifier Source: org_study_id

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