Perineural Steroids for Peripheral Nerve Blocks

Wake Forest University Health Sciences85 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

DexamethasoneDRUG

Used in nerve block mixture

BupivacaineDRUG

Used in nerve block mixture

EpinephrineDRUG

Used in nerve block mixture

Saphenous Peripheral Nerve Block

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Duration of Sensory Nerve Block

The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. Testing will occur every two hours.

Time frame: 12 to 48 hours

Secondary Outcomes

Verbal Pain Scores

Verbal Pain Scores will be compared between groups as obtained every six hours during hospitalization. Patients will be asked to provide verbal pain scores both at rest and with movement on a scale of 0-10 (0 being no pain and 10 being the worst pain). These scores will be taken at 0, 6, 12, 18, 24, and 30 hours.

Time frame: 0 to 30 hours

Rate of Post Operative Nausea and Vomiting

Number of participants that experienced nausea and vomiting was recorded.

Time frame: 0 to 30 hours

Neurologic Complications

Each patient will be followed for neurologic complications (paresthesias, etc) if they should occur.

Time frame: throughout study completion, up to 48 hours

Post Operative Opioid Use and Consumption

Amount of opioid use and consumption was recorded.

Time frame: 0-30 hours

Time to First Opioid Analgesic Request

Time it took for the first opioid analgesic request was recorded.

Time frame: 0 to 36 hours

Data from ClinicalTrials.gov

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