Perineural Steroids for Peripheral Nerve Blocks

Phase 4

Completed

Conditions: Osteoarthritis, Knee

Interventions: Drug: Dexamethasone
Drug: Bupivacaine
Drug: Epinephrine
Procedure: Saphenous Peripheral Nerve Block

Registration Number: NCT02462148

Lead Sponsor: Wake Forest University Health Sciences

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 85

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 mg Perineural Dexamethasone Group	Saphenous Peripheral Nerve Block	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.
1 mg Perineural Dexamethasone Group	Dexamethasone	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.
1 mg Perineural Dexamethasone Group	Saphenous Peripheral Nerve Block	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.
Placebo Group	Bupivacaine	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.
4 mg Perineural Dexamethasone Group	Epinephrine	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.
Placebo Group	Saphenous Peripheral Nerve Block	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.
4 mg Perineural Dexamethasone Group	Dexamethasone	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.
4 mg Perineural Dexamethasone Group	Bupivacaine	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.
1 mg Perineural Dexamethasone Group	Bupivacaine	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.
1 mg Perineural Dexamethasone Group	Epinephrine	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.
Placebo Group	Epinephrine	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.

Primary Outcome Measures

Name	Time	Method
Duration of Sensory Nerve Block	12 to 48 hours	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.

Secondary Outcome Measures

Name	Time	Method
Rate of Post Operative Nausea and Vomiting	0 to 30 hours	Number of participants that experienced nausea and vomiting was recorded.
Verbal Pain Scores	0 to 30 hours	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.
Post Operative Opioid Use and Consumption	0-30 hours	Amount of opioid use and consumption was recorded.
Time to First Opioid Analgesic Request	0 to 36 hours	Time it took for the first opioid analgesic request was recorded.
Neurologic Complications	throughout study completion, up to 48 hours	Each patient will be followed for neurologic complications (paresthesias, etc) if they should occur.