Perineural Steroids for Peripheral Nerve Blocks

Study Overview
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Brief Summary
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This study will look at the efficacy of dexamethasone for prolongation of peripheral nerve blocks.

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.

Official Title
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Perineural Steroids for Saphenous Peripheral Nerve Blocks: An Equivalency Dosing Study.

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Bupivacaine
* Drug: Epinephrine
* Procedure: Saphenous Peripheral Nerve Block


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4 mg Perineural Dexamethasone Group<br>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. | Drug: Dexamethasone<br>* Used in nerve block mixture<br>* Other names: Dexamethasone Sodium Phosphate Injection;Drug: Bupivacaine<br>* Used in nerve block mixture<br>* Other names: Bupivacaine Hydrochloride;Drug: Epinephrine<br>* Used in nerve block mixture<br>* Other names: Adrenaline;Procedure: Saphenous Peripheral Nerve Block<br>* Peripheral nerve block.<br>* Other names: Adductor Canal Peripheral Nerve Block;|
| Experimental: 1 mg Perineural Dexamethasone Group<br>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. | Drug: Dexamethasone<br>* Used in nerve block mixture<br>* Other names: Dexamethasone Sodium Phosphate Injection;Drug: Bupivacaine<br>* Used in nerve block mixture<br>* Other names: Bupivacaine Hydrochloride;Drug: Epinephrine<br>* Used in nerve block mixture<br>* Other names: Adrenaline;Procedure: Saphenous Peripheral Nerve Block<br>* Peripheral nerve block.<br>* Other names: Adductor Canal Peripheral Nerve Block;|
| Placebo Comparator: Placebo Group<br>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. | Drug: Bupivacaine<br>* Used in nerve block mixture<br>* Other names: Bupivacaine Hydrochloride;Drug: Epinephrine<br>* Used in nerve block mixture<br>* Other names: Adrenaline;Procedure: Saphenous Peripheral Nerve Block<br>* Peripheral nerve block.<br>* Other names: Adductor Canal Peripheral Nerve Block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 to 48 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Local, Anesthesia, Anesthesia, Conduction, Bupivacaine, Dexamethasone, Saphenous, Adductor Canal, Nerve Block, Analgesia, Preanesthetic Medication, Perioperative Period, Peripheral Nerve Block