Perineural Steroids for Peripheral Nerve Blocks

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis, Knee

Treatments: Drug: Bupivacaine; Drug: Epinephrine; Drug: Dexamethasone; Procedure: Saphenous Peripheral Nerve Block

Study type: Interventional

Funder types: Other

Identifiers

NCT02462148

IRB00032807

Details and patient eligibility

About

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

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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85 participants in 3 patient groups, including a placebo group

4 mg Perineural Dexamethasone Group

Experimental group

Description:

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.

Treatment:

Procedure: Saphenous Peripheral Nerve Block

Drug: Epinephrine

Drug: Dexamethasone

Drug: Bupivacaine

1 mg Perineural Dexamethasone Group

Experimental group

Description:

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.

Treatment:

Procedure: Saphenous Peripheral Nerve Block

Drug: Epinephrine

Drug: Dexamethasone

Drug: Bupivacaine

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Saphenous Peripheral Nerve Block

Drug: Epinephrine

Drug: Bupivacaine