Does Perineural Dexamethasone Increase the Duration of an Ulnar Nerve Block When Controlling for Systemic Effects?

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-07

Study Completion Date

2021-05-15

Brief Summary

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Investigators will assess if perineural dexamethasone can increase the duration of an ulnar nerve block when controlling for systemic effects in healthy volunteers.

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Detailed Description

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Healthy volunteers will have bilateral ulnar nerve blocks performed with bupivacaine on two different days with a minimum of 14 days wash-out. On one day, the participants will also receive dexamethasone in one arm and placebo in the other. On the other day, the participants will also receive placebo in one arm and lidocaine in the other. By this using this design, the investigators will be able to assess if perineural dexamethasone can increase the duration of an ulnar nerve block when controlling for the systemic effects. Furthermore, to ensure blinding, the investigators have also incorporated the lidocaine group which also allows for the assessment of the effects of adding lidocaine to a peripheral nerve block with bupivacaine. The order of which the participant will receive dexamethasone and lidocaine will be random. It will also be random in which arm the participant receives dexamethasone and lidocaine.

Conditions

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Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomised, blinded, placebo-controlled, paired, non-inferiority trial in healthy volunteers.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The trial medication will be identical in appearance and will be prepared in syringes of identical appearance with an identical volume of trial medication by an un-masked nurse who is not otherwise involved in the trial. The participant, anaesthesiologist performing the blocks, the investigators, and the outcome assessors for all outcomes will be masked to treatment allocation.

Study Groups

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Perineural dexamethasone

Bilateral ulnar nerve blocks with bupivacaine. Dexamethasone will be added perineurally in this arm on the same day as the 'systemic dexamethasone' group.

Group Type EXPERIMENTAL

Perineural dexamethasone

Intervention Type DRUG

Dexamethasone 4mg will be added perineurally to an ulnar nerve block with bupivacaine.

Systemic dexamethasone

Bilateral ulnar nerve blocks with bupivacaine. Placebo (saline) will be added perineurally in this arm on the same day as the 'perineural dexamethasone' group. Thereby, this ulnar nerve block will only be affected by the perineurally added dexamethasone that is absorbed and redistributed systemically.

Group Type ACTIVE_COMPARATOR

Systemic dexamethasone

Intervention Type DRUG

Dexamethasone will be added perineurally to an ulnar nerve block with bupivacaine, some will be reabsorbed and distributed systemically. Thereby, the investigators control for the systemic effects of adding perineural dexamethasone to an ulnar nerve block.

Placebo

Bilateral ulnar nerve blocks with bupivacaine. Placebo (saline) will be added perineurally in this arm on the same day as lidocaine group. This will be the actual placebo group.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline will be added perineurally to an ulnar nerve block with bupivacaine.

Perineural lidocaine

Bilateral ulnar nerve blocks with bupivacaine. Lidocaine will be added perineurally in this arm on the same day as the actual placebo group.

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Lidocaine 40 mg will be added perineurally to an ulnar nerve block with bupivacaine.

Interventions

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Perineural dexamethasone

Dexamethasone 4mg will be added perineurally to an ulnar nerve block with bupivacaine.

Intervention Type DRUG

Lidocaine

Lidocaine 40 mg will be added perineurally to an ulnar nerve block with bupivacaine.

Intervention Type DRUG

Placebo

Saline will be added perineurally to an ulnar nerve block with bupivacaine.

Intervention Type DRUG

Systemic dexamethasone

Dexamethasone will be added perineurally to an ulnar nerve block with bupivacaine, some will be reabsorbed and distributed systemically. Thereby, the investigators control for the systemic effects of adding perineural dexamethasone to an ulnar nerve block.

Intervention Type DRUG

Other Intervention Names

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Saline

Eligibility Criteria

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Inclusion Criteria

* Age of 18 years or above
* Must fully understand the protocol and sign written informed consent
* American Society of Anaesthesiologists Physical Status Classification System of 1 or 2
* Body Mass Index above 18 kg/m\^2
* For fertile women, safe contraceptives for the last month and negative urine human chorionic gonadotropin is required

Exclusion Criteria

* Participants unable to cooperate
* Participants unable to speak or read Danish
* Age above 65 years
* Cardiovascular disease
* Allergy to study medication
* History of alcohol or substance abuse
* Intake of corticosteroids within the last 14 days
* Daily intake of prescription analgesia within the last four weeks
* Intake of over-the-counter analgesia within the last 48 hours
* Neuromuscular diseases or wounds on the arms or hands preventing adequate test or block performance.
* Diabetes mellitus

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes