Perineural Steroids for Peripheral Nerve Blocks

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462148
• Other study ID #: IRB00032807
• Status: Completed
• Phase: Phase 4
• Start date: July 2015
• Est. completion date: August 31, 2017

Study information

• Verified date: September 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Dexamethasone
Used in nerve block mixture
• Bupivacaine
Used in nerve block mixture
• Epinephrine
Used in nerve block mixture

Procedure:
• Saphenous Peripheral Nerve Block
Peripheral nerve block.

Locations

Country	Name	City	State
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

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