IV Dexamethasone for Prolongation of Peripheral Nerve Block

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

PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-12

Study Completion Date

2018-02-20

Brief Summary

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This is a volunteer study examining the effect of different doses of IV dexamethasone on prolongation of median nerve block in the forearm.

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Detailed Description

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18 healthy volunteers aged 18-50 will be recruited (6 patients in each dosing group). Each volunteer will receive two forearm median nerve blocks separated by a two week washout period. One block will be conducted alongside an infusion of normal saline (control). The other block will be conducted alongside a randomised dose of IV dexamethasone (2, 4 or 8mg). The order of these interventions will be random. Blocks will be assessed quantitatively with cold and sharp sensation, electrical stimulation, quantitative sensory testing (thermal tolerance) and grip strength dynamometry. Measures or sensory and motor block including onset, intensity and duration will be compared between dosing groups.

Conditions

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Anesthesia, Conduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexamethasone 2mg

The experimental intervention in this arm will be an IV infusion of 2mg of dexamethasone. Volunteers will also have a cross-over placebo comparator (saline infusion).

Group Type EXPERIMENTAL

IV dexamethasone

Intervention Type DRUG

An infusion of IV dexamethasone

Dexamethasone 4mg

The experimental intervention in this arm will be an IV infusion of 4mg of dexamethasone. Volunteers will also have a cross-over placebo comparator (saline infusion).

Group Type EXPERIMENTAL

IV dexamethasone

Intervention Type DRUG

An infusion of IV dexamethasone

Dexamethasone 8mg

The experimental intervention in this arm will be an IV infusion of 8mg of dexamethasone. Volunteers will also have a cross-over placebo comparator (saline infusion).

Group Type EXPERIMENTAL

IV dexamethasone

Intervention Type DRUG

An infusion of IV dexamethasone

Interventions

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IV dexamethasone

An infusion of IV dexamethasone

Intervention Type DRUG

Other Intervention Names

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Dexamethasone sodium phosphate injection USP

Eligibility Criteria

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Inclusion Criteria

* ASA 1 (normal healthy) volunteers.
* 18 - 50 years of age.
* 60 - 100kg weight.
* English speaking.
* Female volunteers of childbearing potential will be required to provide a negative pregnancy test before being allowed to participate.
* Females of child bearing potential must be willing to use medically acceptable birth control methods between study interventions and for a minimum of 2 weeks following the second nerve block.

Exclusion Criteria

* Medical disorders (including bleeding disorders).
* Use of systemic steroids within 2 weeks of the study, prescription medications, live viral vaccines or any recreational drug use.
* Hypersensitivity to bupivacaine, dexamethasone or any component of saline.
* Contraindication to regional anesthetic block.
* Inability to provide informed consent.
* Baseline abnormality of hand sensation or motor function.
* Pregnancy / breast feeding.
* Individuals with mental health disorders (for example bipolar disorder or depression).
* Individuals with cataracts or glaucoma.
* Any known contraindication to IV dexamethasone as per the product monograph - bacteremia and systemic fungal infections, hypersensitivity to any of the products components, gastric and duodenal ulcers, certain viral infections i.e. varicella herpes genitalis.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes