Perineural Steroids for Peripheral Nerve Blocks

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-08-31

Brief Summary

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This study will look at the efficacy of dexamethasone for prolongation of peripheral nerve blocks.

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Detailed Description

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The purpose of this randomized, double-blinded, placebo-controlled trial is to examine if dexamethasone given perineurally as an adjuvant to the nerve block will prolong the time to recovery from sensory nerve block from a saphenous (or adductor canal) nerve block. The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. If this primary end point is met, this study will also serve as an equivalency dosing study comparing 1 mg of perineural dexamethasone to 4 mg of perineural dexamethasone.

Conditions

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Osteoarthritis, Knee

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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4 mg Perineural Dexamethasone Group

4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Used in nerve block mixture

Bupivacaine

Intervention Type DRUG

Used in nerve block mixture

Epinephrine

Intervention Type DRUG

Used in nerve block mixture

Saphenous Peripheral Nerve Block

Intervention Type PROCEDURE

Peripheral nerve block.

1 mg Perineural Dexamethasone Group

1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Used in nerve block mixture

Bupivacaine

Intervention Type DRUG

Used in nerve block mixture

Epinephrine

Intervention Type DRUG

Used in nerve block mixture

Saphenous Peripheral Nerve Block

Intervention Type PROCEDURE

Peripheral nerve block.

Placebo Group

This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural.

Group Type PLACEBO_COMPARATOR

Bupivacaine

Intervention Type DRUG

Used in nerve block mixture

Epinephrine

Intervention Type DRUG

Used in nerve block mixture

Saphenous Peripheral Nerve Block

Intervention Type PROCEDURE

Peripheral nerve block.

Interventions

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Dexamethasone

Used in nerve block mixture

Intervention Type DRUG

Bupivacaine

Used in nerve block mixture

Intervention Type DRUG

Epinephrine

Used in nerve block mixture

Intervention Type DRUG

Saphenous Peripheral Nerve Block

Peripheral nerve block.

Intervention Type PROCEDURE

Other Intervention Names

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Dexamethasone Sodium Phosphate Injection Bupivacaine Hydrochloride Adrenaline Adductor Canal Peripheral Nerve Block

Eligibility Criteria

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Inclusion Criteria

* elective robotic medial MAKO partial knee arthroplasty
* agreed to a regional anesthesia technique

Exclusion Criteria

* contraindications to regional anesthesia
* presence of a progressive neurological deficit
* a pre-existing coagulopathy, infection
* insulin and non-insulin dependent diabetes mellitus
* systemic use of corticosteroids within 30 days of surgery
* chronic use of an opioid analgesic (\>3 months or a combined total of more than 40 mg Oxycodone equivalents a day)
* pregnancy
* a prior history of an adverse event (for example: psychosis) or an allergy to dexamethasone

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes