Does Perineural Dexamethasone Prolong Duration of a Nerve Block?

NCT ID: NCT02351804

Last Updated: 2015-09-01

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

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-03-31

Brief Summary

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The purpose of this study is to investigate whether dexamethasone as an adjuvant to ropivacaine for adductor canal block increases duration of the sensory block, when controlling for a systemic effect using a paired design and bilateral blocks.

The investigators hypothesize that adding dexamethasone to ropivacaine will prolong block duration compared with ropivacaine + placebo.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ropivacaine + dexamethasone

20 ml ropivacaine 0.5% + 0.5 ml dexamethasone 4 mg7ml

Group Type EXPERIMENTAL

Ropivacaine + dexamethasone

Intervention Type DRUG

Adductor canal block, single bolus

Ropivacaine + placebo

20 ml ropivacaine 0.5% + 0.5 ml isotonic saline ad

Group Type PLACEBO_COMPARATOR

Ropivacaine + placebo

Intervention Type DRUG

Adductor canal block, single bolus

Interventions

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Ropivacaine + dexamethasone

Adductor canal block, single bolus

Intervention Type DRUG

Ropivacaine + placebo

Adductor canal block, single bolus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists class 1
* Body Mass Index 18-30

Exclusion Criteria

* Allergy to study medication
* Earlier trauma or surgery to lower limb
* Diabetes Mellitus
* Alcohol or drug abuse
* Daily intake of opioids or steroids last 4 weeks
* Daily intake of any analgesics last 48 hours
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Pia Jaeger

Coordinating Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pia Jæger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital

Gentofte Municipality, Hellerup, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2014-004879-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SM2-PJ-14

Identifier Type: -

Identifier Source: org_study_id

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