Clinical trial NCT02462148: Perineural Steroids for Peripheral Nerve Blocks
Official title: Perineural Steroids for Saphenous Peripheral Nerve Blocks: An Equivalency Dosing Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: Anesthesia
Anesthesia, Conduction
Anesthesia, Local
Bupivacaine
Dexamethasone
Saphenous
Adductor Canal
Nerve Block
Analgesia
Preanesthetic Medication
Perioperative Period
Peripheral Nerve Block
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of Sensory Nerve Block
timeFrame: 12 to 48 hours
Secondary outcomes:
measure: Verbal Pain Scores
timeFrame: 0 to 30 hours
measure: Rate of Post Operative Nausea and Vomiting
timeFrame: 0 to 30 hours
measure: Neurologic Complications
timeFrame: throughout study completion, up to 48 hours
measure: Post Operative Opioid Use and Consumption
timeFrame: 0-30 hours
measure: Time to First Opioid Analgesic Request
timeFrame: 0 to 36 hours
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Daryl S Henshaw, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turner JD, Henshaw DS, Weller RS, Jaffe JD, Edwards CJ, Reynolds JW, Russell GB, Dobson SW. Perineural dexamethasone successfully prolongs adductor canal block when assessed by objective pinprick sensory testing: A prospective, randomized, dose-dependent, placebo-controlled equivalency trial. J Clin Anesth. 2018 Aug;48:51-57. doi: 10.1016/j.jclinane.2018.05.009. Epub 2018 May 9.