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Perineural Steroids for Peripheral Nerve Blocks

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ClinicalTrials.gov Identifier: NCT02462148
Recruitment Status : Completed
First Posted : June 3, 2015
Results First Posted : August 7, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Dexamethasone Drug: Bupivacaine Drug: Epinephrine Procedure: Saphenous Peripheral Nerve Block Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perineural Steroids for Saphenous Peripheral Nerve Blocks: An Equivalency Dosing Study.
Study Start Date : July 2015
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 4 mg Perineural Dexamethasone Group
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
Used in nerve block mixture
Other Name: Dexamethasone Sodium Phosphate Injection

Drug: Bupivacaine
Used in nerve block mixture
Other Name: Bupivacaine Hydrochloride

Drug: Epinephrine
Used in nerve block mixture
Other Name: Adrenaline

Procedure: Saphenous Peripheral Nerve Block
Peripheral nerve block.
Other Name: Adductor Canal Peripheral Nerve Block
Experimental: 1 mg Perineural Dexamethasone Group
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
Used in nerve block mixture
Other Name: Dexamethasone Sodium Phosphate Injection

Drug: Bupivacaine
Used in nerve block mixture
Other Name: Bupivacaine Hydrochloride

Drug: Epinephrine
Used in nerve block mixture
Other Name: Adrenaline

Procedure: Saphenous Peripheral Nerve Block
Peripheral nerve block.
Other Name: Adductor Canal Peripheral Nerve Block
Placebo Comparator: Placebo Group
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
Used in nerve block mixture
Other Name: Bupivacaine Hydrochloride

Drug: Epinephrine
Used in nerve block mixture
Other Name: Adrenaline

Procedure: Saphenous Peripheral Nerve Block
Peripheral nerve block.
Other Name: Adductor Canal Peripheral Nerve Block


Outcome Measures
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Primary Outcome Measures :
  1. Duration of Sensory Nerve Block [ Time Frame: 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 :
  1. Verbal Pain Scores [ Time Frame: 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.

  2. Rate of Post Operative Nausea and Vomiting [ Time Frame: 0 to 30 hours ]
    Number of participants that experienced nausea and vomiting was recorded.

  3. Neurologic Complications [ Time Frame: throughout study completion, up to 48 hours ]
    Each patient will be followed for neurologic complications (paresthesias, etc) if they should occur.

  4. Post Operative Opioid Use and Consumption [ Time Frame: 0-30 hours ]
    Amount of opioid use and consumption was recorded.

  5. Time to First Opioid Analgesic Request [ Time Frame: 0 to 36 hours ]
    Time it took for the first opioid analgesic request was recorded.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462148


Locations
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United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Daryl S Henshaw, MD Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
Study Protocol and Statistical Analysis Plan  [PDF] August 7, 2015

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02462148    
Other Study ID Numbers: IRB00032807
First Posted: June 3, 2015    Key Record Dates
Results First Posted: August 7, 2018
Last Update Posted: September 24, 2018
Last Verified: September 2018
Keywords provided by Wake Forest University Health Sciences:
Anesthesia
Anesthesia, Conduction
Anesthesia, Local
Bupivacaine
Dexamethasone
Saphenous
 Adductor Canal
Nerve Block
Analgesia
Preanesthetic Medication
Perioperative Period
Peripheral Nerve Block
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Dexamethasone
Dexamethasone acetate
Epinephrine
Bupivacaine
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents