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Completed

NCT Number: NCT02462148

Perineural Steroids for Peripheral Nerve Blocks

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

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Key information

Conditions

Osteoarthritis, Knee Agnosia Arthritis Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Osteoarthritis Pathological Conditions, Signs and Symptoms Perceptual Disorders Rheumatic Diseases Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Used in nerve block mixture

Other names: Dexamethasone Sodium Phosphate Injection

Bupivacaine

Drug

Used in nerve block mixture

Other names: Bupivacaine Hydrochloride

Epinephrine

Drug

Used in nerve block mixture

Other names: Adrenaline

Saphenous Peripheral Nerve Block

Procedure

Peripheral nerve block.

Other names: Adductor Canal Peripheral Nerve Block

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 3, 2015
Registry last updated
Sep 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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