Dexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-16

Study Completion Date

2019-04-30

Brief Summary

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When used as perineural (PN) adjuvants to local anesthetics (LAs), dexamethasone (DX) and dexmedetomidine (DXD) have been well documented to prolong the duration of peripheral nerve blocks. These drugs have important differences in terms of cost and safety profiles. This randomized controlled trial (RCT) will compare PN DX and PN DXD for ultrasound-guided infraclavicular brachial plexus blocks (ICBs).

Since analgesic and sensory duration can be influenced by factors different to block, motor block duration is the main outcome. The protocol is designed as an equivalency trial and hypothesize that both drugs result in similar durations. The equivalency margin is set at 3 hrs.

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Detailed Description

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Conditions

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Pain, Postoperative Pain, Acute Upper Extremity Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Perineural dexamethasone

addition of dexamethasone to local anesthetics in infraclavicular brachial plexus block

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Dexamethasone as perineural local anesthetic adjuvant

Perineural dexmedetomidine

addition of dexmedetomidine to local anesthetics in infraclavicular brachial plexus block

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine as perineural local anesthetic adjuvant

Interventions

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Dexamethasone

Dexamethasone as perineural local anesthetic adjuvant

Intervention Type DRUG

Dexmedetomidine

Dexmedetomidine as perineural local anesthetic adjuvant

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age between 18 and 75 years
* American Society of Anesthesiologists classification 1-3
* body mass index between 20 and 35

Exclusion Criteria

* adults who are unable to give their own consent
* pre-existing neuropathy (assessed by history and physical examination)
* coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
* renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
* hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
* allergy to local anesthetics (LAs)
* pregnancy
* prior surgery in the infraclavicular region
* chronic pain syndromes requiring opioid intake at home

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No