Perineural Steroids for Peripheral Nerve Blocks

NCT02462148 | Completed Phase 4 Results

• 1 other identifier: IRB00032807
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis, Knee

Keywords

Anesthesia; Anesthesia, Conduction; Anesthesia, Local; Bupivacaine; Dexamethasone; Saphenous; Adductor Canal; Nerve Block; Analgesia; Preanesthetic Medication; Perioperative Period; Peripheral Nerve Block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Verbal Pain Scores

  0 to 30 hours

• Rate of Post Operative Nausea and Vomiting

  0 to 30 hours

• Neurologic Complications

  throughout study completion, up to 48 hours

• Post Operative Opioid Use and Consumption

  0-30 hours

• Time to First Opioid Analgesic Request

  0 to 36 hours

Study Arms (3)

4 mg Perineural Dexamethasone Group

EXPERIMENTAL

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

1 mg Perineural Dexamethasone Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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; Drug: Epinephrine; Procedure: Saphenous Peripheral Nerve Block

Interventions

Dexamethasone DRUG

Used in nerve block mixture

Also known as: Dexamethasone Sodium Phosphate Injection

1 mg Perineural Dexamethasone Group; 4 mg Perineural Dexamethasone Group

Bupivacaine DRUG

Used in nerve block mixture

Also known as: Bupivacaine Hydrochloride

1 mg Perineural Dexamethasone Group; 4 mg Perineural Dexamethasone Group; Placebo Group

Epinephrine DRUG

Used in nerve block mixture

Also known as: Adrenaline

1 mg Perineural Dexamethasone Group; 4 mg Perineural Dexamethasone Group; Placebo Group

Saphenous Peripheral Nerve Block PROCEDURE

Peripheral nerve block.

Also known as: Adductor Canal Peripheral Nerve Block

1 mg Perineural Dexamethasone Group; 4 mg Perineural Dexamethasone Group; Placebo Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective robotic medial MAKO partial knee arthroplasty
• agreed to a regional anesthesia technique

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• Turner JD, Henshaw DS, Weller RS, Jaffe JD, Edwards CJ, Reynolds JW, Russell GB, Dobson SW. Perineural dexamethasone successfully prolongs adductor canal block when assessed by objective pinprick sensory testing: A prospective, randomized, dose-dependent, placebo-controlled equivalency trial. J Clin Anesth. 2018 Aug;48:51-57. doi: 10.1016/j.jclinane.2018.05.009. Epub 2018 May 9.

  PMID: 29753264 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Agnosia

Interventions

Dexamethasone; dexamethasone 21-phosphate; Bupivacaine; Epinephrine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Dr. Jimmy Turner
• Organization: Wake Forest Baptist Health

jturner@wakehealth.edu

3368064498

Study Officials

• Daryl S Henshaw, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 3, 2015
• Study Start: July 1, 2015
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: September 24, 2018
• Results First Posted: August 7, 2018

Record last verified: 2018-09

Locations

US (1)